SSDI Manual.02.15.2023

Site-Specific Data Item (SSDI) Manual

Effective with Cases Diagnosed 1/1/2018 and Forward

Published October 2022

Version 3.0

Editors: Jennifer Ruhl, MSHCA, RHIT, CCS, CTR, NCI SEER

Jim Hofferkamp, CTR, NAACCR

Suggested Citation: Ruhl J, Hofferkamp J, et al. (October 2022). Site-Specific Data Item (SSDI)

Manual. NAACCR, Springfield, IL 62704-4194

Funding for this project was made possible in part by a contract with Federal funds from the National

Cancer Institute, National Institutes of Health and Department of Health & Human Services under

Contract number HHSN261201400004I / HHSN26100002. Additionally, funding for this project was

made possible in part by a cooperative agreement with Federal funds from the Centers for Disease

Control and Prevention Cooperative Agreement number 5NU58DP004917. Its contents are solely the

responsibility of the authors and do not necessarily represent the official views of the NCI and CDC. The

NAACCR Board of Directors adopted these standards in February 2018.

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NAACCR gratefully acknowledges the dedicated work of the 2020-2022 NAACCR Site-Specific Data Item

(SSDI) Work Group.

Jennifer Ruhl, MSHCA, RHIT, CCS, CTR (NCI SEER) (chair)

Melissa Alvarado (NPCR)

Mary Brant, BS, CTR (California Cancer Registry)

Sheila Fukumura, CTR (Manitoba Cancer Registry)

Daisy Gray (Kentucky Cancer Registry)

Donna Gress, RHIT, CTR (AJCC)

Donna M. Hansen, CTR (California Cancer Registry)

Jim Hofferkamp, CTR (NAACCR)

Mei-Chin Hsieh, PhD (Louisiana Cancer Registry)

Annette Hurlbut, RHIT, CTR (Elekta)

Suzanne Kessler, MSM, RHIT, CTR (American College of Surgeons)

Richard Moldwin, M.D., Ph.D (College of American Pathologists)

Serban Negoita, MD, DrPH, CPH, CTR (NCI SEER)

Lisa Pareti, BS, RHIT, CTR (Louisiana Cancer Registry)

Loria Pollack, MD, MPH (Centers for Disease Control and Prevention)

Nicola Schussler, BS (IMS)

Aleisha Williams, MBA, CTR (AJCC)

Janine Smith, BS, CTR (California Cancer Registry)

Special Acknowledgements

Carolyn Callaghan, CTR and Tiffany Janes, CTR from the SEER*Educate program, and to Denise Harrison,

CTR (Trainer, Educatory) for their continued contribution to the SSDI Work Group

The AJCC Expert Panels for their continued critical support in clarifying concepts from the AJCC Cancer

Staging Manual, Eighth Edition and AJCC Cancer Staging System Version 9.

The College of American Pathologists (CAP) for their continued support with a CAP representative on the

SSDI Work Group and the recent participation by the CAP Cancer Committee to deal with specific issues.

CAP participation allows us to harmonize data elements between AJCC, NAACCR and the CAP Cancer

Protocols (CCPs), and electronic Cancer Checklists (eCCs). Since the terminology on many pathology

reports is guided by the latest CPPs and eCCs, the new CAP-consistent language in many of the SSDI

value sets and notes will ease the burden of coding current pathology terminology into exact matches

with NAACCR value sets. This is part of a broader effort to work towards improving interoperability

between EHR data sets and NAACCR SSDIs.

The following individuals contributed to document support and web development.

Suzanne Adams, BS, CTR (IMS)

Kathy Conklin, MSCS, Manger of IT, AJCC

Dustin Dennison, M.MIS (Information Technology Administrator, NAACCR)

Chuck May, BS (IMS)

Daniel Oluwadare, Programmer, AJCC

Nicola Schussler, BS (IMS)

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Table of Contents

Organization of the SSDI Manual and Suggestions for How to Use it ........................................................ 13

Introduction ................................................................................................................................................ 15

Timing for collection of SSDIs ..................................................................................................................... 17

Consult Reports ........................................................................................................................................... 18

General Definitions and Format of SSDI Codes........................................................................................... 19

Source Documents ...................................................................................................................................... 20

General Rules for Entering Laboratory Values and Other Measurements ................................................. 21

Rules for Recording Laboratory Values ....................................................................................................... 24

Rules for Recording Tests Based on Solid Tissue ........................................................................................ 28

Histologic Examination................................................................................................................................ 30

Schema Discriminators ............................................................................................................................... 31

3926: Schema Discriminator 1 ....................................................................................................... 32

3927: Schema Discriminator 2 ....................................................................................................... 33

3928: Schema Discriminator 3 ....................................................................................................... 34

SSDIs Required for Stage ............................................................................................................................. 35

SSDIs used for EOD Derived Stage Group ................................................................................................... 36

3800: Schema ID (2018+) ............................................................................................................................ 37

Schema ID Table ........................................................................................................................... 38

HEAD AND NECK ......................................................................................................................................... 48

00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+) .......... 49

3926: Schema Discriminator 1: Occult Head and Neck Lymph Nodes ............................................... 49

3831: Extranodal Extension Head and Neck Clinical ........................................................................... 53

3832: Extranodal Extension Head and Neck Pathological .................................................................. 56

3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other) ........................................... 59

3876: LN Head and Neck Levels I-III .................................................................................................... 61

3877: LN Head and Neck Levels IV-V .................................................................................................. 63

3878: LN Head and Neck Levels VI-VII ................................................................................................ 65

3879: LN Head and Neck Other........................................................................................................... 67

3883: LN Size ....................................................................................................................................... 69

00071: Lip (2018+) ........................................................................................................................ 71

00072: Tongue Anterior (2018+) ................................................................................................... 71

00073: Gum (2018+) ..................................................................................................................... 71

00074: Floor of Mouth (2018+) ..................................................................................................... 71

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00075: Palate Hard (2018+)........................................................................................................... 71

00076: Buccal Mucosa (2018+) ...................................................................................................... 72

00077: Mouth Other (2018+) ........................................................................................................ 72

00080: Major Salivary Glands (2018+) ........................................................................................... 72

00090: Nasopharynx (2018+) ........................................................................................................ 72

3926: Schema Discriminator 1: Nasopharynx/Pharyngeal Tonsil ....................................................... 73

00100: Oropharynx HPV-Mediated (p16+) (2018+) ........................................................................ 74

3927: Schema Discriminator 2: Oropharyngeal p16 ........................................................................... 75

00111: Oropharynx (p16-) (2018+) ................................................................................................ 76

00112: Hypopharynx (2018+) ........................................................................................................ 77

00121: Maxillary Sinus (2018+) ..................................................................................................... 77

00122: Nasal Cavity and Ethmoid Sinuses (2018+) ......................................................................... 77

00130: Larynx Other (2018+) ......................................................................................................... 77

00131: Larynx Supraglottic (2018+) ............................................................................................... 77

00132: Larynx Glottic (2018+) ....................................................................................................... 77

00133: Larynx SubGlottic (2018+) .................................................................................................. 78

00140: Mucosal Melanoma of the Head and Neck (2018+) ............................................................. 78

00150: Cutaneous Carcinoma of the Head and Neck (2018+) ......................................................... 78

3858: High Risk Histologic Features .................................................................................................... 79

GASTROINTESTINAL TRACT (UPPER AND LOWER) ...................................................................................... 81

00161: Esophagus (including GE junction) Squamous (2018+) ........................................................ 82

3926: Schema Discriminator 1: EsophagusGEJunction (EGJ)/Stomach .............................................. 82

3927: Schema Discriminator 2: Histology Discriminator for 8020/3 .................................................. 85

3829: Esophagus and EGJ Tumor Epicenter ........................................................................................ 86

3855: HER2 Overall Summary ............................................................................................................. 88

00169: Esophagus (including GE junction) (excluding Squamous) (2018+) ....................................... 90

00170: Stomach (2018+) ............................................................................................................... 90

00190: Appendix (2018-2022) ....................................................................................................... 90

09190: Appendix (2023+) .............................................................................................................. 90

3960: Histologic Subtype .................................................................................................................... 91

00200: Colon and Rectum (2018+)................................................................................................. 93

3819, 3820: CEA Pretreatment Lab Value and Interpretation ............................................................ 93

3820: CEA Pretreatment Lab Value..................................................................................................... 94

3819: CEA Pretreatment Interpretation ............................................................................................. 96

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3823: Circumferential Resection Margin (CRM) ................................................................................. 98

3866: KRAS ........................................................................................................................................ 101

3890: Microsatellite Instability (MSI)................................................................................................104

3909: Perineural Invasion ................................................................................................................. 107

3934: Tumor Deposits ....................................................................................................................... 109

3940: BRAF Mutational Analysis ....................................................................................................... 111

3941: NRAS Mutational Analysis ....................................................................................................... 113

09210: Anus (2023+) ................................................................................................................... 116

3956: p16 .......................................................................................................................................... 116

HEPATOBILIARY SYSTEM ........................................................................................................................... 117

00220: Liver (2018+) ................................................................................................................... 118

3809, 3810: Alpha-Fetoprotein (AFP) Pretreatment Lab Value and Interpretation (Liver) .............. 118

3810: AFP Pretreatment Lab Value ................................................................................................... 119

3809: AFP Pretreatment Interpretation ........................................................................................... 120

3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score ............................ 121

3813: Bilirubin Pretreatment Total Lab Value .................................................................................. 124

3814: Bilirubin Pretreatment Unit of Measure ................................................................................. 126

3824: Creatinine Pretreatment Lab Value ........................................................................................ 127

3825: Creatinine Pretreatment Unit of Measure .............................................................................. 129

3860: International Normalized Ratio .............................................................................................. 130

3835: Fibrosis Score .......................................................................................................................... 131

002300: Bile Ducts Intrahepat (2018+) ........................................................................................ 133

3917: Primary Sclerosing Cholangitis ................................................................................................ 134

3935: Tumor Growth Pattern............................................................................................................ 136

00242: Cystic Duct (2018+) .......................................................................................................... 138

3926: Schema Discriminator 1: BileDuctsDistal/BileDuctsPerihilar/CysticDuct ............................... 138

00250: Bile Ducts Perhilar (2018+) .............................................................................................. 140

00260: Bile Duct Distal (2018+) ................................................................................................... 140

00280: Pancreas (2018+) ............................................................................................................. 141

3942: CA 19-9 PreTx Lab Value ......................................................................................................... 141

00290: NET Stomach (2018+) ...................................................................................................... 143

3863: Ki-67 ........................................................................................................................................ 143

00301: NET Duodenum (2018+)................................................................................................... 145

00302: NET Ampulla of Vater (2018+) .......................................................................................... 145

00310: NET Jejunum and Ileum (2018+)....................................................................................... 145

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00320: NET Appendix (2018+) ..................................................................................................... 145

00330: NET Colon and Rectum (2018+) ........................................................................................ 145

00340: NET Pancreas (2018+) ...................................................................................................... 145

THORAX ..................................................................................................................................................... 146

00360: Lung (2018+) ................................................................................................................... 147

3929: Separate Tumor Nodules ........................................................................................................ 147

3937: Visceral and Parietal Pleural Invasion ..................................................................................... 150

3938: ALK Rearrangement ................................................................................................................ 153

3939: EGFR Mutational Analysis ....................................................................................................... 155

00370: Pleura Mesothelioma (2018+) .......................................................................................... 157

3913: Pleural Effusion ....................................................................................................................... 157

BONE ......................................................................................................................................................... 159

00381: Bone Appendicular Skeleton (2018+) ............................................................................... 160

3908: Percent Necrosis Post Neoadjuvant........................................................................................ 160

00382: Bone Spine (2018+) ......................................................................................................... 162

00383: Bone Pelvis (2018+) ......................................................................................................... 162

SOFT TISSUE SARCOMA ............................................................................................................................ 163

00400: Soft Tissue Head and Neck (2018+) .................................................................................. 164

3815: Bone Invasion .......................................................................................................................... 164

00410: Soft Tissue Trunk and Extremities (2018+) ........................................................................ 166

3927: Schema Discriminator 2: Soft Tissue Sarcoma (C473, C475, C493-C495) ............................... 167

00421: Soft Tissue Abdomen and Thoracic (2018+) ...................................................................... 171

00422: Heart, Mediastinum and Pleura (2018+)........................................................................... 171

00430: GIST (2018+) ................................................................................................................... 172

3926: Schema Discriminator 1: Primary Peritoneum Tumor ............................................................ 172

3865: KIT Gene Immunohistochemistry ........................................................................................... 173

00440: Retroperitoneum (2018+) ................................................................................................ 175

00458: Soft Tissue Rare (2018+) .................................................................................................. 175

00459: Soft Tissue Other (2018+) ................................................................................................ 175

SKIN ........................................................................................................................................................... 176

00460: Merkel Cell Carcinoma (2018+) ........................................................................................ 177

3830: Extranodal Extension Clin (non-Head and Neck) .................................................................... 177

3833: Extranodal Extension Path (non-Head and Neck) ................................................................... 179

3880: LN Isolated Tumor Cells (ITC) .................................................................................................. 181

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3918: Profound Immune Suppression .............................................................................................. 183

00470: Melanoma Skin (2018+) ................................................................................................... 185

3817: Breslow Tumor Thickness ....................................................................................................... 185

3936: Ulceration ................................................................................................................................ 188

3893: Mitotic Rate Melanoma .......................................................................................................... 190

3932: LDH Lab Value ......................................................................................................................... 192

3869: LDH Level ................................................................................................................................. 194

3870: LDH Upper Limits of Normal ................................................................................................... 195

3961: Clinical Margin Width .............................................................................................................. 197

BREAST ...................................................................................................................................................... 199

00480: Breast (2018+) ................................................................................................................. 200

Estrogen Receptor and Progesterone Receptor ............................................................................... 200

3827: Estrogen Receptor Summary .................................................................................................. 202

3826: Estrogen Receptor Percent Positive or Range ........................................................................ 204

3828: Estrogen Receptor Total Allred Score ..................................................................................... 206

3915: Progesterone Receptor Summary ........................................................................................... 208

3914: Progesterone Receptor Percent Positive or Range ................................................................. 210

3916: Progesterone Receptor Total Allred Score ............................................................................. 212

HER2 .................................................................................................................................................. 214

3850: HER2 IHC Summary ................................................................................................................. 217

3854: HER2 ISH Summary ................................................................................................................. 219

3855: HER2 Overall Summary ........................................................................................................... 221

3853: HER2 ISH Single Probe Copy Number ..................................................................................... 223

3851: HER2 ISH Dual Probe Copy Number........................................................................................ 225

3852: HER2 ISH Dual Probe Ratio ..................................................................................................... 227

Multigene Signature Method and Results ........................................................................................ 229

3894: Multigene Signature Method .................................................................................................. 231

3895: Multigene Signature Results ................................................................................................... 233

Oncotype Dx Tests ............................................................................................................................ 235

3903: Oncotype Dx Recurrence Score-DCIS ...................................................................................... 237

3905: Oncotype Dx Risk Level-DCIS .................................................................................................. 238

3904: Oncotype Dx Recurrence Score-Invasive ................................................................................ 239

3906: Oncotype Dx Risk Level-Invasive ............................................................................................. 241

3863: Ki-67 ........................................................................................................................................ 242

3882: LN Positive Axillary Level I-II ................................................................................................... 244

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3922: Response to Neoadjuvant Therapy ......................................................................................... 247

FEMALE REPRODUCTIVE ORGANS ............................................................................................................ 249

3836: FIGO ........................................................................................................................................ 250

Lymph Node Assessment Methods & Status for Regional & Distant Lymph Nodes in GYN Sites .... 253

00500: Vulva (2018+) .................................................................................................................. 254

3836: FIGO: Vulva ............................................................................................................................. 254

3959: LN Status: Femoral-Inguinal .................................................................................................... 255

3871: LN Assessment Method Femoral-Inguinal .............................................................................. 257

3957: LN Status: Pelvic ...................................................................................................................... 259

3873: LN Assessment Method Pelvic ................................................................................................ 261

3881: LN Laterality ............................................................................................................................ 263

00510: Vagina (2018+) ................................................................................................................ 265

3836: FIGO: Vagina............................................................................................................................ 265

3959: LN Status: Femoral-Inguinal .................................................................................................... 266

3871: LN Assessment Method Femoral-Inguinal .............................................................................. 268

3958: LN Status: Para-Aortic ............................................................................................................. 270

3872: LN Assessment Method Para-Aortic ....................................................................................... 272

3957: LN Status: Pelvic ...................................................................................................................... 274

3873: LN Assessment Method Pelvic ................................................................................................ 276

3875: LN Distant: Mediastinal, Scalene ............................................................................................ 278

3874: LN Distant Assessment Method .............................................................................................. 279

00520: Cervix (2018-2020) .......................................................................................................... 280

3836: FIGO: Cervix............................................................................................................................. 281

09520: Cervix (2021+) ................................................................................................................. 283

3956: p16 .......................................................................................................................................... 284

00528: Cervix Sarcoma ............................................................................................................... 285

00530: Corpus Carcinoma and Carcinosarcoma (2018+) ............................................................... 286

3836: FIGO: Corpus Carcinoma and Carcinosarcoma ....................................................................... 286

3899-3902: Number of Positive and Examined Para-Aortic and Pelvic Nodes ................................. 288

3901: Number of Positive Para-Aortic Nodes ................................................................................... 289

3899: Number of Examined Para-Aortic Nodes ................................................................................ 291

3902: Number of Positive Pelvic Nodes ............................................................................................ 293

3900: Number of Examined Pelvic Nodes ......................................................................................... 295

3911: Peritoneal Cytology ................................................................................................................. 297

00541: Corpus Sarcoma (2018+) .................................................................................................. 299

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3836: FIGO Stage (Sarcoma) ............................................................................................................. 300

00542: Corpus Adenosarcoma (2018+) ........................................................................................ 301

3836: FIGO Stage (Adenosarcoma) ................................................................................................... 302

00551: Ovary (2018+) ................................................................................................................. 303

3836: FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma ........................................................ 303

3818: CA-125 Pretreatment Interpretation ...................................................................................... 305

3921: Residual Tumor Volume Post Cytoreduction .......................................................................... 307

00552: Primary Peritoneal Carcinoma (2018+) ............................................................................. 309

00553: Fallopian Tube (2018+) .................................................................................................... 310

00560: Placenta (2018+) ............................................................................................................. 311

3836: FIGO: Gestational Trophoblastic Tumors (Placenta) .............................................................. 311

3837: Gestational Trophoblastic Prognostic Scoring Index .............................................................. 312

MALE GENITAL ORGANS ........................................................................................................................... 314

00570: Penis (2018+) .................................................................................................................. 315

00580: Prostate (2018+) ............................................................................................................. 316

3920: PSA (Prostatic Specific Antigen) Lab Value ............................................................................. 316

Gleason Patterns and Scores ............................................................................................................ 319

3838: Gleason Patterns Clinical ........................................................................................................ 322

3840: Gleason Score Clinical ............................................................................................................. 325

3839: Gleason Patterns Pathological ................................................................................................ 327

3841: Gleason Score Pathological ..................................................................................................... 330

3842: Gleason Tertiary Pattern ......................................................................................................... 332

Number of Cores Positive and Examined .......................................................................................... 333

3898: Number of Cores Positive ....................................................................................................... 334

3897: Number of Cores Examined .................................................................................................... 336

00590: Testis (2018+) .................................................................................................................. 338

Testis Serum Markers and S Category .............................................................................................. 338

Alpha-fetoprotein (AFP) (Testis) ....................................................................................................... 339

3807: AFP Pre-Orchiectomy Lab Value ............................................................................................. 341

3808: AFP Pre-Orchiectomy Range ................................................................................................... 343

3805: AFP Post-Orchiectomy Lab Value ............................................................................................ 345

3806: AFP Post-Orchiectomy Range ................................................................................................. 347

Human Chorionic Gonadotropin (hCG) (Testis) ................................................................................ 349

3848: hCG Pre-Orchiectomy Lab Value ............................................................................................. 351

3849: hCG Pre-Orchiectomy Range .................................................................................................. 352

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3846: hCG Post-Orchiectomy Lab Value ........................................................................................... 353

3847: hCG Post-Orchiectomy Range ................................................................................................. 355

Lactate Dehydrogenase (LDH) (Testis)..............................................................................................357

3868: LDH Pre-Orchiectomy Range................................................................................................... 359

3867: LDH Post-Orchiectomy Range ................................................................................................. 360

3923: S Category Clinical ................................................................................................................... 362

3924: S Category Pathological .......................................................................................................... 364

URINARY TRACT ........................................................................................................................................ 366

00600: Kidney Parenchyma (2018+) ............................................................................................ 367

3864: Invasion Beyond Capsule ........................................................................................................ 367

3886: Major Vein Involvement ......................................................................................................... 369

3861: Ipsilateral Adrenal Gland Involvement ................................................................................... 371

3925: Sarcomatoid Features ............................................................................................................. 373

00631: Urethra (2018+) .............................................................................................................. 375

3926: Schema Discriminator 1: Urethra/Prostatic Urethra .............................................................. 375

00633: Urethra-Prostatic (2018+) ................................................................................................ 376

OPHTHALMIC SITES ................................................................................................................................... 377

00640: Skin Eyelid (2018+) .......................................................................................................... 378

3909: Perineural Invasion ................................................................................................................. 378

00660: Melanoma Conjunctiva (2018+) ....................................................................................... 380

00671: Melanoma Iris (2018+) .................................................................................................... 381

3926: Schema Discriminator 1: Melanoma Ciliary Body/Melanoma Iris .......................................... 381

3821: Chromosome 3 Status ............................................................................................................. 382

3822: Chromosome 8q Status ........................................................................................................... 384

3834: Extravascular Matrix Patterns ................................................................................................. 386

3887: Measured Basal Diameter ....................................................................................................... 388

3888: Measured Thickness ............................................................................................................... 390

3891: Microvascular Density ............................................................................................................. 392

3892: Mitotic Count Uveal Melanoma .............................................................................................. 394

00672: Melanoma Choiroid and Ciliary Body (2018+) ................................................................... 396

00680: Retinoblastoma (2018+) .................................................................................................. 397

3856: Heritable Trait ......................................................................................................................... 397

00690: Lacrimal Gland (2018+) .................................................................................................... 399

3926: Schema Discriminator 1: Lacrimal Gland/Sac ......................................................................... 400

3803: Adenoid Cystic Basaloid Pattern ............................................................................................. 401

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00698: Lacrimal Sac (2018+) ........................................................................................................ 403

CENTRAL NERVOUS SYSTEM ..................................................................................................................... 404

00721: Brain (2018-2022) ............................................................................................................ 405

3816: Brain Molecular Markers ........................................................................................................ 405

3801, 3802: Loss of Heterozygosity: Chromosome 1p and Chromosome 19q (CNS) ....................... 407

3801: Chromosome 1p: Loss of Heterozygosity (LOH) ..................................................................... 408

3802: Chromosome 19q: Loss of Heterozygosity (LOH) ................................................................... 410

3889: Methylation of O6-Methylguanine-Methyltransferase .......................................................... 412

09721: Brain (2023+) .................................................................................................................. 414

00722: CNS Other (2018-2022) .................................................................................................... 415

09722: CNS Other (2023+) ........................................................................................................... 416

09724: Medulloblastoma (2023+) ............................................................................................... 417

ENDOCRINE SYSTEM ................................................................................................................................. 418

00730: Thyroid (2018+) ............................................................................................................... 419

3926: Schema Discriminator 1: Thyroid Gland/Thyroglossal Duct ................................................... 419

00740: Thyroid Medullary (2018+) .............................................................................................. 420

HEMATOLOGIC MALIGNANCIES ................................................................................................................ 421

00790: Lymphoma (excluding CLL/SLL) (2018+) ........................................................................... 422

3926: Schema Discriminator 1: Histology Discriminator for 9591/3 ................................................ 422

3812: B Symptoms ............................................................................................................................ 423

3859: HIV Status ................................................................................................................................ 425

3896: NCCN International Prognostic Index (IPI) .............................................................................. 427

00795: Lymphoma-CLL/SLL (2018+) ............................................................................................. 429

Rai Classification ............................................................................................................................... 430

3885: Lymphocytosis......................................................................................................................... 432

3804: Adenopathy ............................................................................................................................. 434

3907: Organomegaly ......................................................................................................................... 436

3811: Anemia .................................................................................................................................... 438

3933: Thrombocytopenia .................................................................................................................. 440

3955: Derived Rai stage .................................................................................................................... 442

00811: Mycosis Fungoides (2018+) .............................................................................................. 443

3910: Peripheral Blood Involvement ................................................................................................ 443

00821: Plasma Cell Myeloma (2018+) .......................................................................................... 446

RISS Stage (Plasma Cell Myeloma) .................................................................................................... 446

3926: Schema Discriminator 1: Plasma Cell Myeloma Terminology ................................................ 447

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3931: Serum Beta-2 Microglobulin Pretreatment Level ................................................................... 448

3930: Serum Albumin Pretreatment Level ....................................................................................... 449

3857: High Risk Cytogenetics............................................................................................................450

3869: LDH Level ................................................................................................................................. 451

00830: HemeRetic (2018+) .......................................................................................................... 452

3862: JAK 2 ........................................................................................................................................ 453

99999: Ill-Defined Other (2018+) ................................................................................................. 455

ALPHABETICAL INDEX ............................................................................................................................... 456

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Organization of the SSDI Manual and Suggestions for How to Use it

The Site-Specific Data Item (SSDI) manual is the primary resource for documentation and coding

instructions for site-specific data items introduced in 2018. Information in the SSDI Manual is similar to

that provided in the Collaborative Stage v2 (CSv2) Manual Part I, Section II for Site Specific Factors (SSF).

Before using the Manual as an information resource for specific data items, it is important to review the

introductory materials and general instructions carefully. Although the majority of data items that are

collected as SSDIs were previously collected as SSFs, the format of the data items and allowable values

have changed substantially, particularly for laboratory values.

Information about the SSDIs has been organized using primary site groupings and presented in the order

used in the AJCC Manuals, a format that is familiar and useful to registrars and most others using the

SSDI Manual. However, we have also provided an alphabetical index for the SSDIs with the

corresponding page number in the last 2 pages of the Manual for those who may want to search it for a

specific SSDI by data item name. The Table of Contents for the Manual contains hyperlinks so that

clicking anywhere on the line where an SSDI and page number are listed will take you directly to that

page in the Manual.

An important new concept introduced in 2018 is the use of a Schema ID to define the applicable SSDIs

and grade table for a particular tumor, based on primary site, histology, and in some cases, additional

information. The appropriate Schema ID will be defined by registry software and will not have to be

assigned by the registrar. However, a Schema ID Table defining the Schema ID number, description and

associated SSDIs is provided in the SSDI Manual for reference purposes. The Schema ID Table will also be

useful for registrars abstracting cases before their software is available. In addition to Schema IDs, the

Schema ID Table also provides the applicable SSDIs with a hyperlink to the page on which the

description of the relevant SSDIs begins. A hyperlink at the end of the information on each SSDI can be

used to return to the Schema ID Table.

For each SSDI, the SSDI Manual includes:

NAACCR Data Item Name

Item Length

NAACCR Item #

NAACCR Alternative Name

Schema ID(s)

Description

o The description is a brief summary used to define the data item in the NAACCR data

dictionary

Rationale

o The rationale describes the reason why the data item is collected, such as required for

staging or recommended for registry data collection by AJCC. If the data item was

collected in CSv2, the primary site and SSF# is included in the rationale

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Definition

o The definition provides additional background on the data item and its clinical

importance. This information was previously included in the CSv2 Manual, Part I, Section

Additional Information

o This section may include source documents, other names, normal reference ranges and

any other information deemed relevant for a particular SSDI. This information was

previously included in the CSv2 Manual, Part I, Section II

Coding instructions and Codes

o Coding instructions are provided as numbered notes. Codes are provided in a table.

Codes and coding instructions are usually provided in registry software.

Appendix A

Appendix A, presented in Schema ID order, provides detailed information on the sites, histologies and

behavior codes included in each schema, along with the applicable SSDIs, grade table, EOD Schema

Name, Summary Stage 2018 Chapter and the current AJCC Staging System. This information is used in

registry software development and may also be useful to researchers and others interested in

understanding schema definitions.

Appendix B

Appendix B is an excel spreadsheet which lists all of the CSv2 site specific factors by CS Schema, their

current status (based on CoC), primary site, and (where applicable), the NAACCR v18 Data Item # and

Name.

Appendix C

Appendix C is a WORD document which lists all the SSDIs in numerical order, the applicable Schema ID(s)

and the start and end year.

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Introduction

In 2018, Collaborative Stage (CS) Site-Specific Factors (SSFs) will be discontinued and Site-Specific Data

Items (SSDIs) will be used for collection of site-specific information. SSDIs will have unique names and

NAACCR data item numbers and can be applied to as many sites as needed. Unlike SSFs, field length is

not limited to 3 digits, decimals are allowed, and different coding conventions are used to record actual

values, percentages and ranges. NAACCR is the custodian of the SSDIs and the SSDI TF is responsible for

their development and updates.

The NAACCR Site-Specific Data Item Taskforce

In October 2016, the NAACCR Site-Specific Data Item (SSDI) Taskforce was formed to determine how to

collect information recorded in the site-specific factors (SSFs) which are part of the Collaborative Stage

software (CS DLL). The taskforce evaluated the structure of the CS SSFs and made recommendations on

how the information should be collected and then updated/revised the format, codes, and coding

instructions as needed.

Taskforce members evaluated several different ways of collecting the information. The final decision

was to discontinue the CS SSF approach and create new individual site-specific data items (SSDIs) for

data collection beginning with cases diagnosed in 2018. There are several reasons for this decision.

More flexibility

No longer will all site-specific data items be three characters in length. Some are shorter, others

are longer

Also, registrars can record lab values with the decimal point as part of the code.

Meaningful names

Each new data item has been given a name that will be displayed in registry software.

o For example, the software displays ER instead of Breast, SSF1

It is easier for registrars and researchers to retrieve data.

o For example, query the database for PSA instead of remembering that SSF1 is PSA in

Prostate

Reduced duplication

CS SSFs which were collected for multiple sites/chapters/schema under different SSF numbers

are now one data item when possible

What is a SSDI?

A “SSDI’” is a site-specific data item. “Site” in this instance is based on the primary site, the AJCC Staging

System, Summary Stage chapter and the EOD schema. SSDIs were preceded by CS SSFs, which were first

introduced in 2004 with CSv1, and went through major revisions in 2010 with Collaborative Stage v2

(CSv2). CS SSFs were discontinued as of 12/31/2017.

SSDIs have their own data item name and number and can be collected for as many sites/systems

/schemas as needed.

Each Site-Specific Data Item (SSDI) applies only to selected schemas. SSDI fields should be blank for

schemas where they do not apply.

Unless otherwise noted, all SSDIs start collection in 2018. For those that have a collection start date later

than 2018, a note has been added to instruct registrars when it should be collected.

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How SSDIs are associated with relevant site/histologies and schemas

In Collaborative Stage v2 (CSv2), 153 Schemas were defined based on site/histology and used to assign

applicable site-specific factors (SSFs) and staging algorithms. For 2018, Schema ID [3800] is used to link

all combinations of sites and histologies (using additional information from schema discriminators if

needed) with the appropriate stage data collection systems and SSDIs. AJCC ID [995] is used to link AJCC

staging eligible sites/histologies (using additional information from schema discriminators if needed)

with the appropriate AJCC Staging System and staging algorithm. Schema ID and AJCC ID will be derived

by registry software based on site and histology codes entered by the registrar. Refer to Appendix A for

a complete listing of schemas IDs and related schema information.

Process of Developing the SSDIs

Development of the SSDIs began with reviewing the CS SSFs. Due to the number of CS SSFs, and the fact

that many of them were discontinued in CSv0204, a priority order was established.

First: schema discriminators. These are data items needed to determine the correct SSDIs, AJCC

Staging System, EOD schema, or Summary Stage schema

Second: data items required to assign stage

Third: data items currently required by at least one standard setter and listed as registry

collection data items in at least one AJCC Staging System

Last: certain data items required by standard setters and not necessarily stage related. These

comprise a small percentage of the data items

CS SSFs discontinued in CSv0204 were not reviewed for 2018 data collection. New registry data

collection items listed in the AJCC Staging System was not reviewed, unless they are required for staging.

Number of SSDIs compared to CS SSFs

Approximately 260 unique CS SSFs in CSv0205

101 discontinued

12 obsolete

147 required

Of these, 27 are not required for 1/1/2018+

120 SSDIs added to the NAACCR v18 layout

CS SSF data will be retained for cases diagnosed 2004-2017. CS SSF data will not be mapped to the SSDIs.

Collection of CS SSFs or the new SSDIs is based strictly on the date of diagnosis. For cases

diagnosed 2004-2017, CS SSFs will continue to be collected according to the appropriate

standard setter. For cases diagnosed 2018 or later, the SSDIs will be collected according to the

appropriate standard setter

Example: A case diagnosed in 2017 is abstracted in 2018. Code the applicable/required CS SSFs for

that case, not the SSDIs.

For a complete listing of site-specific factors from CSv0205 and the corresponding SSDI (if any) for 2018,

see Appendix B.

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Timing for collection of SSDIs

The SSDIs are to be collected during the initial diagnosis, work up and first course of treatment. Some

SSDIs have specific instructions as to when the SSDIs are collected (e.g., CEA is to be collected prior to

polypectomy, or PSA is to be collected prior to needle core biopsy).

Note: Active surveillance is first course of treatment.

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Consult Reports

If a report is sent out for consult and the results are different than the original report, record the results

from the consult

Example 1: Patient had biopsy done at a facility with a Gleason Score of 4+4=8. Slides were sent out for

consult and their review showed Gleason Score 4+3=7.

Record the Gleason score of 4+3=7 based on the consult.

Example 2: Original pathology report states ER and PR positive. Slides were sent out for consult and their

review showed ER and PR negative.

Record ER and PR as negative

Example 3: Breast pathology report states Grade 3, ER 95% strong on outside pathology. Patient

presents at facility for treatment and the slides from the outside facility are reviewed, with the results of

Grade 2, ER 80% intermediate.

Record Grade 2 and ER 80% intermediate

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General Definitions and Format of SSDI Codes

Not applicable: This code is to be used ONLY when the data item is relevant for the case and the

standard setter does not require the data item. Not applicable codes ALWAYS end in an 8 but will differ

depending on the length of the data item.

Note: “Not applicable” is not available for schema discriminators or data items which are required

for staging.

Examples:

Perineural Invasion. This is a 1-digit field. “Not applicable” is 8

FIGO Stage (for all GYN cases). This is a 2-digit field. “Not applicable” is 98

Creatinine Pretreatment Lab Value. This is a 4-digit field including the decimal point. “Not

applicable” is XX.8

AFP (Alpha Fetoprotein) Pre-Orchiectomy Lab Value. This is a 7-digit field including the decimal

point. “Not applicable” is XXXXX.8

It is important to review each data item carefully to determine how the “not applicable” code is

formatted.

Unknown: Previous codes from CS for test not done (998) and unknown (999) have been combined.

Unknown codes ALWAYS end in a 9 but will differ depending on the length of the data item. The

unknown code includes

Test/evaluation/assessment not done or UNKNOWN if done

“Cannot be determined by pathologist.” For some data items, this is a selection box on the College of

American Pathologists (CAP) checklist. Cannot be determined by pathologist is primarily used when a

tissue specimen is not adequate for testing.

“Not identified.” For some data items, this is a selection box on the CAP checklist. This means that the

pathologist has looked for it and it is not present. This is not the same thing as looking for it in the

medical record and not finding it (this would be “not documented in the medical record.”)

Death Certificate Only (DCOs) cases

For DCOs, the applicable SSDIs (except for applicable Schema Discriminators) may be blank.

Note: This instruction is for central registries only.

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Source Documents

Source documents are suggested for some data items as the most likely sources of information.

If no source document is suggested, use any information provided in the medical record

If a pathology report is suggested, that document includes

o Addenda or revisions to the report

o Gross or microscopic description

o Synoptic reports

o CAP protocol, or cancer checklist information provided by the pathologist

It is important to review each data item carefully to determine where the information can be found. For

some data items, the information is based on imaging or some other type of clinical exam. Other data

items are based on pathological findings from a surgical resection.

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General Rules for Entering Laboratory Values and Other Measurements

Lab values and other measurements that are not integers (whole numbers) and are reported as

continuous variables (not categories or ranges) will be recorded to a single decimal place with an explicit

decimal point.

There must always be a numeral or the letter ‘X’ immediately before the decimal point and a numeral

after the decimal point, which will be in the next-to-last character position in the field. The entered

value must be right-justified in the field and padded with spaces to the left if necessary to fill the field.

Users’ software will usually justify and pad the value automatically for the registrar.

In addition to the actual values, codes are defined for situations such as value unknown; test done but

results not in chart; and other special cases. Sometimes codes will be provided for when a value is

expressed as “at least” some value.

These may be needed, for example, in the measurement of tumor size or thickness when the

tumor has been transected and the actual size cannot be determined. These codes will begin

with one or more ‘X’s.

When a value in the medical record does not provide the expected decimal digit, i.e. it is expressed as a

whole number, then enter the value followed by a decimal point and a zero.

Examples for a 6-Character Lab Value

Value in Record Data Item Coded as

0.0 0.0

0 0.0

.1 0.1

11.0 11.0

11.1 11.1

11 11.0

111.1 111.1

1111.1 1111.1

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Rounding Rules

SSDIs follow the standard definitions for rounding. These general rules can be followed for most SSDIs

where lab values or percentages are recorded. All SSDIs that have lab values, percentages or

measurements are set up to record in the 10ths (one digit after the decimal point). If a lab value,

percentage or measurement is recorded in 100ths (two digits after the decimal point), then the last digit

must be rounded.

The general rounding rules are:

If digit is 0-4, round down

If digit is 5-9, round up

Note: Currently (2018+), the only SSDIs that have exceptions to the general rounding rules are:

o HER2 ISH Single Probe Copy Number

o HER2 ISH Dual Probe Copy Number

o HER2 ISH Dual Probe Ratio

Examples

Breslow’s measurement 4.32 mm

o Since the last digit is 2, round down and record 4.3

CEA lab value 18.35

o Since the last digit is 5, round up and record 18.4

HER2 ISH Dual Probe Copy Number 6.78

o Per note 8: If the test results are presented to the hundredth decimal, ignore the

hundredth decimal. Do NOT round. Record 6.7

o This also applies to HER2 ISH Single Probe Copy Number and HER2 ISH Dual Probe Ratio

Note: ER (and PR) percent positive do not have decimal points in the data items, so anything

with a decimal point will have to be rounded.

o Example: 78.6. Since the last digit is 6, round up and record 079 (79%)

o Note: For ER and PR percent positive, if a value is documented as 99.5% to 99.9%, round

up to 100% (code 100)

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Recording values when “less than” or “greater than” are used

Record the value as one less than stated when a value is reported as “less than X,” and as one more

than stated when a value is reported as “more than X.” One less or one more may refer to a whole

number (1), or a decimal (0.1), depending on the code structure of the field.

SSDIs with decimals in their code structures

Example 1: PSA stated as < (less than) 5. Record 4.9

Example 2: hCG lab value resulting findings of < (less than) 1. Record 0.9

Example 3: Ki-67 reported as > (greater than) 20%. Record 20.1

SSDIs without decimals in their code structure:

Example 1: ER Percent Positive stated as < (less than) 60%. Record 059 (59%)

Example 2: PR Percent Positive stated as > (greater than) 75%. Record 076 (76%)

Example 3: ER Percent Positive < (less than) 50%. Record 049 (49%)

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Rules for Recording Laboratory Values

Laboratory values refer to any tests that are based on blood, urine, ascites, or spinal fluid. Most of these

are based on blood.

Do not apply these rules to SSDIs that are based on tissue; see Rules for Recording Tests Based on Solid

Tissue .

Follow the below guidelines for recording laboratory values:

All laboratory values must be done no earlier than approximately three months before diagnosis

Only record test results obtained before any cancer-directed treatment is given (neoadjuvant

therapy or surgical), unless instructions for a specific laboratory test state otherwise

Record the highest laboratory value if multiple laboratory tests results are available, unless

instructions for a specific laboratory test state otherwise

The following SSDIs record laboratory values. If the SSDI specific coding rules column is yes, then check

the SSDI for additional coding instructions

Schema SSDI# SSDI SSDI Specific Coding

Rules

Colon and Rectum 3820 CEA Pretreatment Lab Value Yes

Colon and Rectum 3819 CEA Pretreatment Interpretation Yes

Liver 3810 AFP Pretreatment Lab Value

Liver 3809 AFP Pretreatment Interpretation

Liver 3813 Bilirubin Pretreatment Total Lab Value

Liver 3814 Bilirubin Pretreatment Unit of Measure

Liver 3820 Creatinine Pretreatment Total Lab Value

Liver 3825 Creatinine Pretreatment Unit of Measure

Liver 3860 International Normalized Ratio for Prothrombin Time

Lymphoma (CLL/SLL) 3811 Anemia

Lymphoma (CLL/SLL) 3933 Thrombocytopenia

Mycosis Fungoides 3910 Peripheral Blood Involvement

Ovary, Fallopian Tube,

Primary Peritoneal

Carcinoma

3818 CA-125 Pretreatment Interpretation

Melanoma Skin 3932 LDH Lab Value Yes

Melanoma Skin 3869 LDH Level Yes

Melanoma Skin 3870 LDH Upper Limits of Normal Yes

Pancreas 3942 CA 19-9 PreTx Lab Value

Plasma Cell Myeloma 3930 Serum Albumin Pretreatment Level

Plasma Cell Myeloma 3931 Serum Beta-2 Microglobulin Pretreatment Level

Plasma Cell Myeloma 3932 LDH Lab Value

Prostate 3920 PSA Lab Value (See SSDI specific instructions) Yes

Testis 3807 AFP Pre-Orchiectomy Lab Value Yes

Testis 3808 AFP Pre-Orchiectomy Range Yes

Testis 3805 AFP Post-Orchiectomy Lab Value Yes

Testis 3806 AFP Post-Orchiectomy Range Yes

Testis 3848 hCG Pre-Orchiectomy Lab Value Yes

Testis 3849 hCG Pre-Orchiectomy Range Yes

Testis 3846 hCG Post-Orchiectomy Lab Value Yes

Testis 3847 hCG Post-Orchiectomy Range Yes

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Schema SSDI# SSDI SSDI Specific Coding

Rules

Testis 3868 LDH Pre-Orchiectomy Range Yes

Testis 3867 LDH Post-Orchiectomy Range Yes

If the only test or tests performed do not meet these criteria, code "test not done" or "unknown if test

performed."

The results of laboratory values vary according to the laboratory conducting the test. The normal

reference range is included in the tumor marker comments as background information only. Some data

items ask for a laboratory value, others ask for the “interpretation” of the laboratory test (normal,

elevated, and so forth).

When the data item asks for the interpretation of a laboratory test, code the clinician’s/pathologist’s

interpretation, if available, as first priority. This would include statements of “abnormal”, “elevated”,

“normal”, “equivocal”, “present”, “absent”, and so forth. In addition, the physician's statement of a T,

N, or M value or stage group for the case could be an implied interpretation of a lab value used to

determine the TNM classification.

Example 1: Physician summarizes breast cancer workup by saying "HER2 IHC was positive at

3+.” Registrar would code interpretation as positive

Note: If the pathologist uses the term "indeterminate," code as borderline; undetermined if

positive or negative if that code exists in the data item. If a code for borderline or

undetermined does not exist, code as unknown

In the absence of a physician’s interpretation of the test, if the reference range for the lab is listed on

the test report, the registrar may use that information to assign the appropriate code.

Example 2: Medical record laboratory report shows ovarian cancer patient's CA-125 as 69

(normal range < 35 U/ml). Registrar may infer that CA-125 is elevated

When there is no clinician/pathologist interpretation of the lab test and no description of the reference

range in the medical record the registrar should code unknown. Do not code the lab value

interpretation based on background information provided in this manual for the data item.

Note: There will be some cases where an interpretation may be inferred from the background

information in this manual because the lab result is extremely abnormal. In such cases, common

sense would dictate that the case should be coded as elevated rather than unknown.

Example 3: Physician reports that Alpha Fetoprotein (AFP) collected in the office for a patient

suspected to have primary liver cancer was 750 but does not interpret this value. Background

information in the manual indicates a high normal would be > 500 but hepatocellular carcinoma

values are > 1000. Registrar should code AFP Interpretation as unknown

Example 4: Physician reports a CEA of 450 for a colon cancer without interpreting

it. Background information in the manual indicates a high normal would be 5 ng/ml. Registrar

may code CEA as elevated

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What does SI mean? SI is the French abbreviation for International System (Systeme Internationale),

standard units of measure (meter, kilogram, second). Most SI values are based on the kilogram and the

liter. A nanogram (ng) is one-thousandth of a microgram . A milliliter (ml) is one-thousandth of a

liter. Therefore, a lab value expressed in mg/L is equivalent to the same value expressed in

ng/ml. Some lab values, such as hormone levels, are recorded in International Units per Liter

(IU/L). This is equivalent to mIU/mL. The equivalence of mIU to ng varies according to what is

measured.

Note that instructions for entering many lab values state that the registrars should not convert the

values. For those where conversion is allowed, one measurement conversion website is:

https://www.amamanualofstyle.com/page/si-conversion-calculator

SI Conversion: 1 mg/L = 1 ng/ml.

For example, 1 ng of AFP is approximately equal to 1 mIU.

Note: Micrograms per liter may be printed as ug/L.

Prefixes and abbreviations. Units of measure can be described and written in various ways in the

medical record. In some circumstances, the unit of measure may be dependent on the printer used for

the report.

For example, the prefix “micron” (one millionth of a unit) is represented in scientific notation by

the Greek letter mu (m), but not all printers have the capability to print Greek symbols. As a

result, micro- may be printed as a lower-case u or as the abbreviation mc.

Do not confuse the abbreviation for micro- (u) with the abbreviation for Unit (an international

system measurement, U).

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Tables I-2-1a – I-2-1c below show abbreviations for units of measurement and the abbreviations for

fractions or multiples of those units.

Table I-2-1a. Measurement Prefixes

Number Prefix Written

1,000,000 Mega- M

1000 Kilo- k

Deka

1 (baseline)

1/10 Deci- d

1/100 Centi- c

1/1000 Milli- m

One millionth Micro- m, u, or mc

One billionth Nano- n

One trillionth

Pico

One quadrillionth Femto f

Table I-2-1b. Unit Abbreviations

Unit Abbrev.

Liter L

Unit U

Meter

Unit-of-substance mole, mol

Gram g, gr

milli-Equivalent mEq, meq

Table I-2-1c. Examples

Unit Abbrev.

Femtomole

fmol

Microgram ugr, mcg, mgr

Milliliter ml

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Rules for Recording Tests Based on Solid Tissue

Priority Order for SSDIs

Addendums or amendments (corrections that are not incorporated into the initial synoptic

report, including CAP Cancer Protocol)

Synoptic report (including CAP Cancer Protocol)

Pathology report: final diagnosis

Physician statement

General Rules versus SSDI specific rules

Unless instructions for a specific tissue test state otherwise, record the highest value (positive

versus negative, or actual numerical value) obtained from any tissue based examination (biopsy,

surgical resection, bone marrow biopsy).

If the SSDI specific coding rules column is yes, then check the SSDI for additional coding

instructions

Schema SSDI# SSDI SSDI Specific

Coding Rules

Bile Ducts Intrahepatic 3935 Tumor Growth Pattern

Bile Ducts Intrahepatic

Liver

3835 Fibrosis Score

Bile Ducts Intrahepatic,

Bile Ducts Perihilar

3917 Primary Sclerosing Cholangitis

Bone 3908 Percent Necrosis Post Neoadjuvant Yes

Brain, CNS 3816 Brain Molecular Markers

Brain, CNS 3801 Chromosome 1p: Loss of Heterozygosity

Brain, CNS 3802 Chromosome 19q: Loss of Heterozygosity

Brain, CNS 3889 Methylation of O6-Methylguanine-Methyltransferase

(MGMT)

Breast 3827 Estrogen Receptor Summary Yes

Breast 3826 Estrogen Receptor Percent Positive or Range Yes

Breast 3828 Estrogen Receptor Total Allred Score Yes

Breast 3882 LN Positive Axillary Level I-II Yes

Breast 3915 Progesterone Receptor Summary Yes

Breast 3914 Progesterone Receptor Percent Positive or Range Yes

Breast 3916 Progesterone Receptor Total Allred Score Yes

Breast 3855 HER2 Overall Summary Yes

Breast 3894 Multigene Signature Method

Breast 3895 Multigene Signature Results

Breast 3903 Oncotype Dx Recurrence Score-DCIS

Breast 3905 Oncotype Dx Risk Level-DCIS

Breast 3904 Oncotype Dx Recurrence Score-Invasive

Breast 3906 Oncotype Dx Risk Level Invasive

Breast 3863 Ki-67 Yes

Colon and Rectum 3823 Circumferential Resection Margin Yes

Colon and Rectum 3866 KRAS

Colon and Rectum 3890 Microsatellite Instability (MSI)

Colon and Rectum 3909 Perineural Invasion Yes

Colon and Rectum 3934 Tumor Deposits Yes

Colon and Rectum 3940 BRAF Mutational Analysis

Colon and Rectum 3941 NRAS Mutational Analysis

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Schema SSDI# SSDI SSDI Specific

Coding Rules

Cutaneous Carcinoma

Skin

3858 High Risk Histologic Features

Cutaneous Carcinoma

Skin

3909 Perineural Invasion Yes

Esophagus (both

schemas)

3855 HER2 Overall Summary

GIST 3865 KIT Gene Immunochemistry

HemeRetic 3862 JAK2

Kidney 3864 Invasion Beyond Capsule Yes

Kidney 3886 Major Vein Involvement Yes

Kidney 3861 Ipsilateral Adrenal Gland Involvement Yes

Kidney 3925 Sarcomatoid Features

Lacrimal Gland 3803 Adenoid Cystic Basaloid Pattern

Lacrimal Gland 3903 Perineural Invasion Yes

Lung 3938 ALK Rearrangement

Lung 3939 EGFR Mutational Analysis

Lung 3937 Visceral and Parietal Pleural Invasion

Melanoma Choroid and

Ciliary Body; Iris

3821 Chromosome 3 status

Melanoma Choroid and

Ciliary Body; Iris

3821 Chromosome 8q status

Melanoma Choroid and

Ciliary Body; Iris

3834 Extravascular Matrix Patterns

Melanoma Choroid and

Ciliary Body; Iris

3887 Measured Basal Diameter

Melanoma Choroid and

Ciliary Body; Iris

3888 Measured Thickness

Melanoma Choroid and

Ciliary Body; Iris

3891 Microvascular Density

Melanoma Choroid and

Ciliary Body; Iris

3892 Mitotic Count Uveal Melanoma

Melanoma Skin 3817 Breslow Tumor Thickness Yes

Melanoma Skin 3936 Ulceration Yes

Melanoma Skin 3893 Mitotic Rate Melanoma

NET Schemas 3863 Ki-67 Yes

Plasma Cell Myeloma 3857 High Risk Cytogenetics

Prostate 3838 Gleason Patterns Clinical Yes

Prostate 3840 Gleason Score Clinical Yes

Prostate 3839 Gleason Patterns Pathological Yes

Prostate 3841 Gleason Score Pathological Yes

Prostate 3898 Number of Cores Positive Yes

Prostate 3897 Number of Cores Examined

Yes

Retinoblastoma 3856 Heritable Trait

Stomach 3855 HER2 Overall Summary

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Histologic Examination

Histologic examination is the assessment of a tissue specimen. Aspiration of fluid (cells) is a cytologic

examination. Some data items require analysis of tissue, whereas others can be performed on any

specimen (tissue or fluid). Pathological examination can refer to either histological or cytological

examination.

Also referred to as “microscopic confirmation.”

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Schema Discriminators

Introduced in Collaborative Stage version 2 (CSv2), schema discriminators are used when primary site

and/or histology are not sufficient to identify the correct AJCC staging algorithm. Due to the complexity

of some of the AJCC Staging System, more than one schema discriminator may be needed to define the

correct schema. Three SSDIs (Data Item #’s 3926, 3927 and 3928) are available to collect the information

needed to define schema, although most sytems that require a schema discriminator need only one.

Schema discriminators are used to define both Schema ID, used to link all combinations of sites and

histologies, with the appropriate stage data collection systems and SSDIs, and AJCC ID, used to link AJCC

staging eligible sites/histologies with the appropriate AJCC Staging System and staging algorithm.

Schema discriminators do not have a “not applicable” code. If the schema discriminator is needed for

some sites or histologies within the schema but not for all, it should be left blank where it is not

necessary.

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3926: Schema Discriminator 1

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Description

Captures additional information needed to generate AJCC ID and Schema ID for some anatomic sites.

Discriminators can be based on sub site, histology or other features which affect prognosis.

Rationale

A schema discriminator is used to assign AJCC ID when site and histology alone are insufficient to

identify the applicable AJCC staging method and to assign Schema ID, which links each case to the

appropriate SSDIs, Summary Stage and EOD data collection system.

Codes (The information recorded in Schema Discriminator differs for each anatomic site. See the SSDI

manual for most current version of the site-specific codes and coding structures.)

The following are Schema Discriminator 1

3926: Schema Discriminator 1: BileDuctsDistal/BileDuctsPerihilar/CysticDuct

3926: Schema Discriminator 1: EsophagusGEJunction (EGJ)/Stomach

3926: Schema Discriminator 1: Histology Discriminator for 9591/3

3926: Schema Discriminator 1: Lacrimal Gland/Sac

3926: Schema Discriminator 1: Melanoma Ciliary Body/Melanoma Iris

3926: Schema Discriminator 1: Nasopharynx/Pharyngeal Tonsil

3926: Schema Discriminator 1: Occult Head and Neck Lymph Nodes

3926: Schema Discriminator 1: Plasma Cell Myeloma Terminology

3926: Schema Discriminator 1: Primary Peritoneum Tumor

3926: Schema Discriminator 1: Thyroid Gland/Thyroglossal Duct

3926: Schema Discriminator 1: Urethra/Prostatic Urethra

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3927: Schema Discriminator 2

Item Length: 1

NAACCR Item #: 3927

XML Parent-NAACCR ID: Tumor-schemaDiscriminator2

NAACCR Alternate Name: None

Active years: 2018+

Description

Captures additional information needed to generate AJCC ID and Schema ID for some anatomic sites.

Discriminators can be based on sub site, histology or other features which affect prognosis.

Rationale

A schema discriminator is used to assign AJCC ID when site and histology alone are insufficient to

identify the applicable AJCC staging method and to assign Schema ID, which links each case to the

appropriate SSDIs, Summary Stage and EOD data collection system.

Codes (The information recorded in Schema Discriminator differs for each anatomic site. See the SSDI

manual for most current version of the site-specific codes and coding structures.)

The following are Schema Discriminator 2

3927: Schema Discriminator 2: Histology Discriminator for 8020/3

3927: Schema Discriminator 2: Oropharyngeal p16

3927: Schema Discriminator 2: Soft Tissue Sarcoma (C473, C475, C493-C495)

34 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

3928: Schema Discriminator 3

Item Length: 1

NAACCR Item #: 3928

XML Parent-NAACCR ID: Tumor-schemaDiscriminator3

NAACCR Alternate Name: None

Active years: 2018+

Description

Captures additional information needed to generate AJCC ID and Schema ID for some anatomic sites.

Discriminators can be based on sub site, histology or other features which affect prognosis.

Rationale

A schema discriminator is used to assign AJCC ID when site and histology alone are insufficient to

identify the applicable AJCC staging method and to assign Schema ID, which links each case to the

appropriate SSDIs, Summary Stage and EOD data collection system.

There are currently no defined Schema Discriminators 3s.

35 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

SSDIs Required for Stage

In addition to AJCC T, N, M or EOD fields (primary tumor, regional nodes, and mets), there are SSDIs that

are needed to either assign an AJCC stage or derive the EOD Derived Stage Group.

Note: Required for stage data items do not have a “not applicable” code. These data items must

be coded for all applicable cases. If the information is not available, code the appropriate

“unknown” value.

For further information on these data items, see the individual data items.

SSDI

#/Description

Schema ID

#/Description

3829: Esophagus and EGJ Tumor Epicenter

00161:

Esophagus (including GE junction) Squamous

3827: Estrogen Receptor Summary 00480: Breast

3915: Progesterone Receptor Summary 00480: Breast

3855: HER2 Overall Summary 00480: Breast

3904: Oncotype Dx Recurrence Score-Invasive 00480: Breast

3837: Gestational Trophoblastic Prognostic Scoring

Index

00560: Placenta

3920: PSA (Prostatic Specific Antigen) Lab Value 00580: Prostate

3923: S Category Clinical 00590: Testis

3924: S Category Pathological 00590: Testis

3856: Heritable Trait 00680: Retinoblastoma

3804: Adenopathy 00795: Lymphoma (CLL/SLL)

3811: Anemia 00795: Lymphoma (CLL/SLL)

3885: Lymphocytosis 00795: Lymphoma (CLL/SLL)

3907: Organomegaly 00795: Lymphoma (CLL/SLL)

3933: Thrombocytopenia 00795: Lymphoma (CLL/SLL)

3910: Peripheral Blood Involvement 00811: Mycosis Fungoides

3857: High Risk Cytogenetics

00821:

Plasma Cell Myeloma

3869: LDH Level

00821:

Plasma Cell Myeloma

3930: Serum Albumin Pretreatment Level 00821: Plasma Cell Myeloma

3931: Serum Beta-2 Microglobulin Pretreatment Level 00821: Plasma Cell Myeloma

36 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

SSDIs used for EOD Derived Stage Group

In addition to the SSDIs required for AJCC stage, the following SSDIs are used for the EOD Derived Stage

group. These SSDIs are only required for those registries that are collecting EOD but may be collected by

others.

SSDI#/Description Schema ID#/Description

3883: LN Size 00100: Oropharynx HPV-Mediated (p16+)

3869: LDH Level 00470: Melanoma Skin

3882: LN Positive Axillary Level I-II 00480: Breast

3911: Peritoneal Cytology 00530: Corpus Carcinoma and Carcinosarcoma

3911: Peritoneal Cytology 00541: Corpus Sarcoma

3911: Peritoneal Cytology 00542: Corpus Adenosarcoma

3887: Measured Basal Diameter 00671: Melanoma Iris

3887: Measured Basal Diameter 00672: Melanoma Choroid and Ciliary Body

3888: Measured Thickness

00671: Melanoma Iris

3888: Measured Thickness

00672: Melanoma Choroid and Ciliary

Body

37 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

3800: Schema ID (2018+)

Item Length: 5

NAACCR Item #: 3800

XML Parent-NAACCR ID: Tumor-schemaID

NAACCR Alternate Name: None

Active years: 2018+

Description

The derived values in this data item link Site-Specific Data Items (including grade data items) with the

appropriate site/histology grouping and account for every combination of primary site and histology.

The values for this data item are derived based on primary site, histology, and schema discriminator

fields (when required). The derived values link Site-Specific Data Items with the appropriate

site/histology grouping.

For example, the Schema ID for an adenocarcinoma of the lung is 00360. This value links the

Site-Specific Data Items associated with adenocarcinoma of the lung: Separate Tumor Nodules

[3929], Visceral and Parietal Pleural Invasion [3937], and Pleural Effusion [3913].

The Schema ID would also link to the appropriate grade data items an adenocarcinoma of the lung. The

AJCC ID [995] code for Lung is 36. The AJCC ID [995] would link to the AJCC TNM Data items (Clin T, Clin

N, Etc.) specific to Lung. AJCC ID [995] will not be assigned when a site/histology combination is not

eligible for TNM staging.

Rationale

The purpose of the derived Schema ID is to link the appropriate Site-Specific Data Items with the

patient’s primary site/histology. This data item is similar to AJCC ID [995] but includes additional

site/histologies that may not be eligible for TNM staging using the current AJCC Staging Manual. AJCC ID

[995] is left blank if a case is not eligible for TNM Staging using the current AJCC Staging Manual.

Separating AJCC ID [995] and the Schema ID allows coding of Site-Specific Data Items for site/histology

combinations that are not eligible for an AJCC Stage but are eligible for Summary Stage. This data item

will also be used to develop edits and could potentially be used for analysis. Codes: See the NAACCR

Site-Specific Data Item webpage for codes. Each Site-Specific Data Item (SSDI) applies only to selected

primary sites, histologies, and years of diagnosis.

Definition

In Collaborative Stage v2 (CSv2), 153 Schemas were defined based on site/histology and used to assign

applicable site-specific factors (SSFs) and staging algorithms. Beginning on January 1, 2018, SSFs are

replaced with SSDIs and site-specific grading systems are used and Schema ID [3800] is used to link all

combinations of sites and histologies (using additional information from schema discriminators if

needed) with the appropriate SSDIs and site-specific grading system. A separate data item, AJCC ID

[995], is used to link AJCC staging eligible sites/histologies (using additional information from schema

discriminators if needed) with the appropriate AJCC Staging System and staging algorithm. Schema ID

and AJCC ID will be derived by registry software based on site and histology codes entered by the

registrar.

38 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Schema ID Table

Schema ID#/Description

SSDI

#/Description

Years Applicable

00060: Cervical Lymph Nodes

and Unknown Primary Tumors

of the Head and Neck (2018+)

3926: Schema Discriminator 1: Occult Head and Neck

Lymph Nodes (primary site C760)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

3883: LN Size

2018+

00071: Lip (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00072: Tongue Anterior

(2018+)

3831

: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00073: Gum (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00074: Floor of Mouth (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00075: Palate Hard (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00076: Buccal Mucosa (2018+)

3831

: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00077: Mouth Other (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00080: Major Salivary Glands

(2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00090: Nasopharynx (2018+) 3926: Schema Discriminator 1:

Nasopharynx/PharyngealTonsil

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

39 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Schema ID#/Description SSDI #/Description Years Applicable

00100: Oropharynx HPV-

Mediated (p16+)

3926: Schema Discriminator 1:

Nasopharynx/PharyngealTonsil

3927: Schema Discriminator 2: Oropharyngeal p16

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00111: Oropharynx (p16-)

(2018+)

3926: Schema Discriminator 1:

Nasopharynx/PharyngealTonsil

3927: Schema Discriminator 2: Oropharyngeal p16

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00112: Hypopharynx (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00118: Pharynx Other (2018+) No SSDIs defined for this Schema ID NA

00119: Middle Ear (2018+) No SSDIs defined for this Schema ID NA

00121: Maxillary Sinus (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00122: Nasal Cavity and

Ethmoid Sinuses (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00128: Sinus Other (2018+)

No SSDIs defined for this Schema ID

00130: Larynx Other (2018+)

3831

: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00131: Larynx Supraglottic

(2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00132: Larynx Glottic (2018+) 3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

00133: Larynx SubGlottic

(2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3883: LN Size

2018+

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Schema ID#/Description SSDI #/Description Years Applicable

00140: Mucosal Melanoma of

the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck

Pathological

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

3883: LN Size

2018+

00150: Cutaneous Carcinoma

of the Head and Neck (2018+)

3858

: High Risk Histologic Features

3883: LN Size

3909: Perineural Invasion

2018+

00161: Esophagus (including

GE junction) Squamous

(2018+)

3926: Schema Discriminator 1: EsophagusGE Junction

(EGJ)/Stomach) (primary site C160)

3927: Schema Discriminator 2: Histology

Discriminator for 8020/3

3829: Esophagus and EGJ Tumor Epicenter

3855: HER2 Overall Summary

2018+

2021+

00169: Esophagus (including

GE junction) (excluding

Squamous) (2018+)

3926: Schema Discriminator 1: EsophagusGE Junction

(EGJ)/Stomach) (primary site C160)

3927: Schema Discriminator 2: Histology

Discriminator for 8020/3

3855: HER2 Overall Summary

2018+

2021+

00170: Stomach (2018+) 3926: Schema Discriminator 1: EsophagusGE Junction

(EGJ)/Stomach) (primary site C160)

3855: HER2 Overall Summary

2018+

2021+

00180: Small

Intestine (2018+)

No SSDIs defined for this Schema ID

00190: Appendix (2018

2022)

3819

: CEA Pretreatment Interpretation

3820: CEA Pretreatment Lab Value

2018

2022

2018-2022

09190: Appendix (2023+)

3819

: CEA Pretreatment Int

erpretation

3820: CEA Pretreatment Lab Value

3960: Histology Subtype

23+

2023+

00200: Colon and Rectum

(2018+)

3819: CEA Pretreatment Interpretation

3820: CEA Pretreatment Lab Value

3823: Circumferential Resection Margin (CRM)

3866: KRAS

3890: Microsatellite Instability (MSI)

3909: Perineural Invasion

3934: Tumor Deposits

3940: BRAF Mutational Analysis

3941: NRAS Mutational Analysis

2018+

2021+

00210: Anus (2018-2022) No SSDIs defined for this Schema ID NA

09210: Anus (2023+) 3956: p 16 2023+

00220: Liver (2018+) 3809: AFP Pretreatment Interpretation

3810: AFP Pretreatment Lab Value

3813: Bilirubin Pretreatment Total Lab Value

3814: Bilirubin Pretreatment Unit of Measure

3824: Creatinine Pretreatment Lab Value

3825: Creatinine Pretreatment Unit of Measure

3835: Fibrosis Score

3860: International Normalized Ratio

2018+

41 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Schema ID#/Description SSDI #/Description Years Applicable

00230: Bile Ducts Intrahepatic

(2018+)

3835: Fibrosis Score

3917: Primary Sclerosing Cholangitis

3935: Tumor Growth Pattern

2018+

00241: Gallbladder No SSDIs defined for this Schema ID

00242: Cystic Duct (2018+) 3926: Schema Discriminator 1:

BileDuctsDistal/BileDuctsPerihilar/ CysticDuct

2018+

00250: Bile Ducts Perhilar

(2018+)

3926: Schema Discriminator 1:

BileDuctsDistal/BileDuctsPerihilar/ CysticDuct

3917: Primary Sclerosing Cholangitis

2018+

00260: Bile Duct Distal (2018+) 3926: Schema Discriminator 1:

BileDuctsDistal/BileDuctsPerihilar/ CysticDuct

2018+

00270: Ampulla of Vater

(2018+)

No SSDIs defined for this Schema ID NA

00278: Biliary Other (2018+) No SSDIs defined for this Schema ID NA

00280: Pancreas (2018+) 3942: CA 19-9 PreTx Lab Value 2021+

00288: Digestive Other (2018+) No SSDIs defined for this Schema ID NA

00290: NET Stomach (2018+) 3863: Ki-67

2021+

00301: NET Duodenum

(2018+)

3863: Ki-67

2021+

00302: NET Ampulla of Vater

(2018+)

3863: Ki-67

2021+

00310: NET Jejunum and Ileum

(2018+)

3863: Ki-67

2021+

00320: NET Appendix (2018+) 3863: Ki-67

2021+

00330: NET Colon and Rectum

(2018+)

3863:

2021+

00340: NET Pancreas (2018+) 3863: Ki-67

2021+

00350: Thymus No SSDIs defined for this Schema ID NA

00358: Trachea No SSDIs defined for this Schema ID NA

00360: Lung (2018+) 3929: Separate Tumor Nodules

3937: Visceral and Parietal Pleural Invasion

3938: ALK Rearrangement

3939: EGFR Mutational Analysis

2018+

2021+

00370: Pleura Mesothelioma

(2018+)

3913: Pleural Effusion 2018+

00378: Respiratory Other

(2018+)

No SSDIs defined for this Schema ID NA

00381: Bone Appendicular

Skeleton (2018+)

3908: Percent Necrosis Post Neoadjuvant 2018+

00382: Bone Spine (2018+) 3908: Percent Necrosis Post Neoadjuvant 2018+

00383: Bone Pelvis (2018+) 3908: Percent Necrosis Post Neoadjuvant 2018+

00400: Soft Tissue Head and

Neck (2018+)

3815: Bone Invasion 2018+

00410: Soft Tissue Trunk and

Extremities (2018+)

3815: Bone Invasion

3927: Schema Discriminator 2: Soft Tissue Trunk and

Extremities/ Soft Tissue Abdomen and Thoracic

2018+

00421: Soft Tissue Abdomen

and Thoracic (2018+)

3815: Bone Invasion

3927: Schema Discriminator 2: Soft Tissue Trunk and

Extremities/ Soft Tissue Abdomen and Thoracic

2018+

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Schema ID#/Description SSDI #/Description Years Applicable

00422: Heart, Mediastinum

and Pleura (2018+)

3815: Bone Invasion 2018+

00430: GIST (2018+) 3926: Schema Discriminator 1: Primary Peritoneum

Tumor

3865: KIT Gene Immunohistochemistry

2018+

00440: Retroperitoneum

(2018+)

3815: Bone Invasion

00458: Soft Tissue Rare

(2018+)

3815: Bone Invasion

00459: Soft Tissue Other

(2018+)

3815: Bone Invasion

3926: Schema Discriminator 1: Occult Head and Neck

Lymph Nodes (primary site C760)

3927: Schema Discriminator 2: Soft Tissue Trunk and

Extremities/ Soft Tissue Abdomen and Thoracic

00458: Kaposi Sarcoma No SSDIs defined for this Schema ID NA

00460: Merkel Cell Carcinoma

(2018+)

3830: Extranodal Extension Clin (non-Head & Neck)

3833: Extranodal Extension Path (non-Head & Neck)

3880: LN Isolated Tumor Cells (ITC)

3918: Profound Immune Suppression

2018+

00470: Melanoma Skin (2018+) 3817: Breslow Tumor Thickness

3936: Ulceration

3893: Mitotic Rate Melanoma

3932: LDH Lab Value

3869: LDH Level

3870: LDH Upper Limits of Normal

3961: Clinical Margin Width

2018+

2023+

00478: Skin Other (2018+) No SSDIs defined for this Schema ID NA

00480: Breast (2018+)

3826

: Estrogen Receptor Percent Positive or Range

3827: Estrogen Receptor Summary

3828: Estrogen Receptor Total Allred Score

3914: Progesterone Receptor Percent Positive or

Range

3915: Progesterone Receptor Summary

3916: Progesterone Total Allred Score

3850: HER2 IHC Summary

3851: HER2 ISH Dual Probe Copy Number

3852: HER2 ISH Dual Probe Ratio

3853: HER2 ISH Single Probe Copy Number

3854: HER2 ISH Summary

3855: HER2 Overall Summary

3894: Multigene Signature Method

3895: Multigene Signature Results

3903: Oncotype Dx Recurrence Score-DCIS

3904: Oncotype Dx Recurrence Score-Invasive

3905: Oncotype Dx Risk Level-DCIS

3906: Oncotype Dx Risk Level-Invasive

3863: Ki-67

3882: LN Positive Axillary Level I-II

3922: Response to Neoadjuvant Therapy

2018

2018+

2018-2022

2018+

2018-2022

2018-2020

2018+

43 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Schema ID#/Description SSDI #/Description Years Applicable

00500: Vulva (2018+) 3836: FIGO Stage (Vulva)

3959: LN Status: Femoral-Inguinal

3871: LN Assessment Method Femoral-Inguinal

3957: LN Status: Pelvic

3873: LN Assessment Method Pelvic

3881: LN Laterality

2018+

00510: Vagina (2018+) 3836: FIGO Stage (Vagina)

3959: LN Status: Femoral-Inguinal

3871: LN Assessment Method Femoral-Inguinal

3958: LN Status: Para-aortic

3872: LN Assessment Method Para-aortic

3959: LN Status: Pelvic

3873: LN Assessment Method Pelvic

3874: LN Distant Assessment Method

3875: LN Distant: Mediastinal, Scalene

2018+

00520: Cervix (2018-2020) 3836: FIGO Stage (Cervix)

3871: LN Assessment Method Femoral-Inguinal

3872: LN Assessment Method Para-aortic

3873: LN Assessment Method Pelvic

3874: LN Distant Assessment Method

3875: LN Distant: Mediastinal, Scalene

2018-2020

09520: Cervix (2021+)

3836

: FIGO Stage (Cervix)

3958: LN Status Para-aortic

3872: LN Assessment Method Para-aortic

3957: LN Status Pelvic

3873: LN Assessment Method Pelvic

3874: LN Distant Assessment Method

3875: LN Distant: Mediastinal, Scalene

3956: p 16

21+

2021+

00528: Cervix Sarcoma 3836: FIGO Stage (Corpus Sarcoma)

3899: Number of Examined Para-Aortic Nodes

3900: Number of Examined Pelvic Nodes

3901: Number of Positive Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3911: Peritoneal Cytology

2021+

00530: Corpus Carcinoma and

Carcinosarcoma

3836: FIGO Stage (Corpus Carcinoma and

Carcinosarcoma)

3899: Number of Examined Para-Aortic Nodes

3900: Number of Examined Pelvic Nodes

3901: Number of Positive Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3911: Peritoneal Cytology

2018+

00541: Corpus Sarcoma 3836: FIGO Stage (Corpus Sarcoma)

3899: Number of Examined Para-Aortic Nodes

3900: Number of Examined Pelvic Nodes

3901: Number of Positive Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3911: Peritoneal Cytology

2018+

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Schema ID#/Description SSDI #/Description Years Applicable

00542: Corpus Adenosarcoma 3836: FIGO Stage (Corpus Adenosarcoma)

3899: Number of Examined Para-Aortic Nodes

3900: Number of Examined Pelvic Nodes

3901: Number of Positive Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3911: Peritoneal Cytology

2018+

00551: Ovary (2018+) 3818: CA-125 Pretreatment Interpretation

3836: FIGO Stage (Ovary, Fallopian Tube and Primary

Peritoneal Carcinomas)

3921: Residual Tumor Volume Post Cytoreduction

2018+

00552: Primary Peritoneal

Carcinoma (2018+)

3818

: CA

125 Pretreatment Interpretation

3836: FIGO Stage (Ovary, Fallopian Tube and Primary

Peritoneal Carcinomas)

3921: Residual Tumor Volume Post Cytoreduction

2018

2018+

00553: Fallopian Tube (2018+) 3818: CA-125 Pretreatment Interpretation

3836: FIGO Stage (Ovary, Fallopian Tube and Primary

Peritoneal Carcinomas)

3921: Residual Tumor Volume Post Cytoreduction

2018+

00558: Adnexa Uterine Other

(2018+)

No SSDIs defined for this Schema ID NA

00559: Genital Female Other

(2018+)

No SSDIs defined for this Schema ID NA

00560: Placenta (2018+) 3836: FIGO Stage (Gestational Trophoblastic Tumors)

3837: Gestational Trophoblastic Prognostic Scoring

Index

2018+

00570: Penis (2018+) 3830: Extranodal Extension Clin (non-Head and Neck)

3833: Extranodal Extension Path (non-Head and

Neck)

2018+

00580: Prostate (2018+) 3838: Gleason Patterns Clinical

3839: Gleason Patterns Pathological

3840: Gleason Score Clinical

3841: Gleason Score Pathological

3842: Gleason Tertiary Pattern

3897: Number of Cores Examined

3898: Number of Cores Positive

3920: PSA (Prostatic Specific Antigen) Lab Value

2018+

00590: Testis (2018+) 3805: AFP Post-Orchiectomy Lab Value

3806: AFP Post-Orchiectomy Range

3807: AFP Pre-Orchiectomy Lab Value

3808: AFP Pre-Orchiectomy Range

3846: hCG Post-Orchiectomy Lab Value

3847: hCG Post-Orchiectomy Range

3848: hCG Pre-Orchiectomy Lab Value

3849: hCG Pre-Orchiectomy Range

3867: LDH Post-Orchiectomy Range

3868: LDH Pre-Orchiectomy Range

3923: S Category Clinical

3924: S Category Pathological

2018+

00598: Genital Male Other

(2018+)

No SSDIs defined for this Schema ID NA

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Schema ID#/Description SSDI #/Description Years Applicable

00600: Kidney Parenchyma

(2018+)

3861: Ipsilateral Adrenal Gland Involvement

3864: Invasion Beyond Capsule

3886: Major Vein Involvement

3925: Sarcomatoid Features

2018+

00610: Kidney Renal Pelvis

(2018+)

No SSDIs defined for this

Schema ID

00620: Bladder (2018+) No SSDIs defined for this Schema ID NA

00631: Urethra (2018+) 3926: Schema Discriminator 1 (Urethra/Prostatic

Urethra)

2018+

00633: Urethra-Prostatic

(2018+)

3926: Schema Discriminator 1 (Urethra/Prostatic

Urethra)

2018+

00638: Urinary Other (2018+) No SSDIs defined for this Schema ID NA

00640: Skin Eyelid (2018+) 3909: Perineural Invasion 2018+

00650: Conjunctiva (2018+) No SSDIs defined for this Schema ID NA

00600: Melanoma Conjunctiva 3888: Measured Thickness 2018+

00671: Melanoma Iris (2018+) 3926: Schema Discriminator 1 (Melanoma Ciliary

Body/Melanoma Iris)

3821: Chromosome 3 Status

3822: Chromosome 8q Status

3834: Extravascular Matrix Patterns

3887: Measured Basal Diameter

3888: Measured Thickness

3891: Microvascular Density

3892: Mitotic Count Uveal Melanoma

2018+

00672: Melanoma Choiroid

and Ciliary Body (2018+)

3926: Schema Discriminator 1 (Melanoma Ciliary

Body/Melanoma Iris)

3821: Chromosome 3 Status

3822: Chromosome 8q Status

3834: Extravascular Matrix Patterns

3887: Measured Basal Diameter

3888: Measured Thickness

3891: Microvascular Density

3892: Mitotic Count Uveal Melanoma

2018+

00680: Retinoblastoma

(2018+)

3856: Heritable Trait 2018+

00690: Lacrimal Gland (2018+) 3926: Schema Discriminator 1 (Lacrimal

Gland/Lacrimal Sac)

3803: Adenoid Cystic Basaloid Pattern

3909: Perineural Invasion

2018+

00698: Lacrimal Sac (2018+)

3926:

Schema Discriminator 1 (Lacrimal

Gland/Lacrimal Sac)

2018

00700: Orbital Sarcoma

(2018+)

No SSDIs defined for this Schema ID

00710: Lymphoma

Ocular

Adnexa (2018+)

No SSDIs defined for this Schema ID

00718: Eye Other (2018+) No SSDIs defined for this Schema ID NA

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Schema ID#/Description SSDI #/Description Years Applicable

00721: Brain (2018-2022) 3801: Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity

(LOH)

3816: Brain Molecular Markers

3889: Methylation of O6-Methylguanine-

Methyltransferase

2018-2022

09721: Brain (2023+) 3801: Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity

(LOH)

3816: Brain Molecular Markers

3889: Methylation of O6-Methylguanine-

Methyltransferase

2023+

00722: CNS Other (2018-2022) 3801: Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity

(LOH)

3816: Brain Molecular Markers

3889: Methylation of O6-Methylguanine-

Methyltransferase

2018-2022

09722: CNS Other (2023+)

3801

Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity

(LOH)

3816: Brain Molecular Markers

3889: Methylation of O6-Methylguanine-

Methyltransferase

2023+

00723: Intracranial Other

(2018-2022)

No SSDIs defined for this Schema ID

09723: Intracranial Other

(2023+)

No SSDIs defined for this Schema ID

09724: Medulloblastoma

(2023+)

3816

: Brain Molecular Markers

2023+

00730: Thyroid (2018+)

3926

Schema Discriminator 1 (Thyroid

Gland/Thyroglossal Duct)

2018

00740: Thyroid Medullary

(2018+)

3926

Schema Discriminator 1 (Thyroid

Gland/Thyroglossal Duct)

2018

00750: Parathyroid (2018+) No SSDIs defined for this Schema ID NA

00760: Adrenal Gland (2018+) No SSDIs defined for this Schema ID NA

00770: NET Adrenal Gland

(2018+)

No SSDIs defined for this Schema ID NA

00778: Endocrine Other

(2018+)

No SSDIs defined for this Schema ID NA

00790: Lymphoma (excluding

CLL/SLL) (2018+)

3926: Schema Discriminator 1 (Histology

Discriminator for 9591/3)

3812: B Symptoms

3859: HIV Status

3896: NCCN International Prognostic Index (IPI)

2018+

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Schema ID#/Description SSDI #/Description Years Applicable

00795: Lymphoma-CLL/SLL

(2018+)

3812: B Symptoms

3859: HIV Status

3896: NCCN International Prognostic Index (IPI)

3804: Adenopathy

3811: Anemia

3812: B symptoms

3859: HIV Status

3885: Lymphocytosis

3896: NCCN International Prognostic Index (IPI)

3907: Organomegaly

3933: Thrombocytopenia

2018+

00811: Mycosis Fungoides

(2018+)

3910

Peripheral Blood Involvement

2018

00812: Primary Cutaneous

Lymphomas (excluding

Mycosis Fungoides) (2018+)

No SSDIs defined for this Schema ID NA

00821: Plasma Cell Myeloma

(2018+)

3926: Schema Discriminator 1 (Multiple Myeloma

Terminology)

3857: High Risk Cytogenetics

3869: LDH Level

3930: Serum Albumin Pretreatment Level

3931: Serum Beta-2 Microglobulin Pretreatment

Level

2018+

00822: Plasma Cell Disorders

(2018+)

No SSDIs defined for this Schema ID

00830: HemeRetic (2018+)

3926

Schema Discriminator 1 (Histology

Discriminator for 9591/3)

3862: JAK2

2018

2018+

99999: ILL-DEFINED OTHER

(2018+)

3926: Schema Discriminator 1 (Occult Head and Neck

Lymph Nodes) (Primary site C760 only)

2018+

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HEAD AND NECK

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3926: Schema Discriminator 1: Occult Head and Neck Lymph Nodes

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00060: Cervical Lymph Nodes and Unknown Primary (2018+)

00459: Soft Tissue Other (2018+)

99999: Ill-Defined Other (2018+)

Definition

In AJCC 8

edition, a new chapter was introduced for situations when there are positive cervical nodes

(head and neck nodes for Levels I-VII, and other group), however, the primary tumor is not evident

(occult tumor) and the primary tumor is suspected to be from the head and neck region (primary sites

C00-C14, C30-32).

If the differential diagnosis includes non-head and neck sites, the primary site should be coded

to C809

o Example: path report states metastasis to the cervical lymph node could be from a head

and neck primary, lung primary, or gynecologic primary

If there is no indication that the cervical lymph node is from a head and neck site, then the

primary site should be coded to C809

If the tumor is found to be EBV+ or p16+. See Coding Guidelines below.

If the tumor is suspected to be from a head and neck site, or a potential head and neck site is

indicated by the physician, see Coding Guidelines below.

To develop a software algorithm that can be used to send the registrar to the right chapter/schema, this

schema discriminator was developed.

To get to this schema discriminator, the registrar will code C760 (head and neck, NOS) when there is a

suspected head and neck tumor, yet the primary site is not known, and/or the primary tumor was not

identified. The schema discriminator will then be brought up.

Note: If the physician “suspects” or “assigns” a specific head and neck subsite, the registrar is

still to assign C760 so that the correct staging information can be abstracted.

o Example: FNA of cervical lymph node metastases shows squamous cell carcinoma, p16

negative. Workup shows no evidence of primary tumor, although physician states this

may be a laryngeal primary based on “best guess”.

Even though the primary site is suspected to be larynx, primary site would still be coded to

C760. For all head and neck sites, except for oropharynx p16+ and nasopharynx EBV positive, no

evidence of primary tumor (T0) does not exist in the individual AJCC chapters or EOD schemas.

These cases are collected as unknown head and neck primary (C760), which will have no

evidence of primary tumor. This Schema ID was designed specifically to group together these

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cases of an occult primary, a tumor that is not identified on physical exam or imaging

techniques.

o Note: Previous instructions were to code these types of cases to C148.

Coding Guidelines

This schema discriminator is based on several different criteria

Positive cervical lymph nodes. This is the overall term used for the head and neck regional lymph

nodes, which include Levels I-VII, and other group.

o For a complete listing of these lymph nodes, see AJCC 8

Edition Chapter 5: Staging

Head and Neck Cancer

o This same information can be found in the EOD and Summary Stage Manuals

No evidence of primary tumor and the suspected primary site is in the head and neck. A specific

head and neck primary site may be suspected, but if there is no clinical/pathological evidence of

the primary tumor, then the case is included in this schema

Epstein-Barr Virus (EBV): EBV positive cancers are associated with nasopharyngeal cancer.

o If the EBV (EBER) test is done and is positive, the primary site should be assigned to

C119 (nasopharynx, NOS) instead of C760, so that the Nasopharynx staging system can

be used. Nasopharynx has a T0, for no evidence of primary tumor

p16: p16 positive cancers in the head and neck are associated with oropharyngeal cancer. p16 is

a surrogate marker for Human Papilloma Virus (HPV).

o If the p16 test is done and positive (and EBV is negative or unknown), the primary site

should be assigned to C109 (oropharynx, NOS) instead of C760, so that the Oropharynx

staging system can be used. Oropharynx has a T0, for no evidence of primary tumor.

o Note: p16 is the only test that can be used for this discriminator. If there is another HPV

test that is positive, the p16 would still be negative for purposes of this data item.

Code 0: Not occult

Primary tumor is evident in the head and neck region; however, a specific primary site cannot be

identified.

Note 1: If overlapping lesions are evident and the primary site cannot be determined, this would

not be a C760, but C148 (overlapping lesions) (Schema ID 00118: Pharynx Other)

Note 2: For tumors in this category, C760 should be used sparingly. If C760 is assigned, this

would be collected in the following schemas: Schema ID 99999: Ill-Defined Other OR Schema ID

00450: Soft Tissue Other (if specified sarcoma)

o Examples include: Cases with limited information, historical case

Code 1: Occult, Negative cervical nodes (regional head and neck nodes)

No evidence of primary tumor or positive cervical lymph nodes (head and neck regional lymph

nodes), suspected head and neck primary.

This type of situation would be rare but would probably be diagnosed based on metastatic

disease, including distant lymph nodes (Mediastinal [excluding superior mediastinal node(s)])

This case would be collected in the Ill-Defined Other schema, or Soft Tissue Other (if specified

sarcoma).

Code 2: Not tested for EBV or p16 in head and neck regional nodes (EBV and p16 both unknown)

There is no documentation in the record regarding p16 or EBV.

Code 3: Unknown EBV, p16 negative in head and neck regional nodes

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p16 is done and reported as negative. No documentation in the medical record regarding EBV.

Code 4: Unknown p16, EBV negative in head and neck regional nodes

EBV done and reported as negative. No documentation in the medical record regarding p16.

Code 5: Negative for both EBV and p16 in head and neck regional nodes

Both EBV and p16 done and reported as negative

EBV Positive EBV Negative EBV Unknown

p16 Positive C11.9 Nasopharynx

(00090:

Nasopharynx)

C10.9 Oropharynx

(00100: Oropharynx HPV-Mediated

(p16+))

C10.9 Oropharynx

(00100: Oropharynx HPV-Mediated

(p16+))

p16

Negative

C11.9 Nasopharynx

(00090:

Nasopharynx)

C76.0 Ill-Defined Site of the Head

and Neck

(00060: Cervical Lymph Nodes and

Unknown Primary)

C76.0 Ill-Defined Site of the Head

and Neck

(00060: Cervical Lymph Nodes and

Unknown Primary)

p16

Unknown

C11.9 Nasopharynx

(00090:

Nasopharynx)

C76.0 Ill-Defined Site of the Head

and Neck

(00060: Cervical Lymph Nodes and

Unknown Primary)

C76.0 Ill-Defined Site of the Head

and Neck

(00060: Cervical Lymph Nodes and

Unknown Primary)

Coding Instructions and Codes

Note 1: This schema discriminator is used to discriminate between head and neck tumors with unknown

primary site coded as C760. Some situations require that a more specific primary site be assigned.

00060: Cervical Lymph Nodes and Unknown Primary

Occult head and neck tumor with cervical metastasis in Levels I-VII, and other group lymph

nodes without a p16 immunostain or with negative results and without an Epstein-Barr virus

(EBV) encoded small RNAs (EBER) by in situ hybridization performed or with negative results are

staged using the AJCC Cervical Lymph Nodes and Unknown Primary Tumors of the Head and

Neck Staging System. Assign primary site C760; code the schema discriminator accordingly.

00090: Nasopharynx

Occult head and neck tumors with cervical metastasis in Levels I-VII, and other group lymph

nodes that is positive for Epstein–Barr virus (EBV+) (regardless of p16 status) encoded small

RNAs (EBER) identified by in situ hybridization are staged using the AJCC Nasopharynx Staging

System. Assign primary site C119; do NOT code this discriminator.

00100: Oropharynx HPV-Mediated (p16+)

Occult head and neck tumors with cervical metastasis in Levels I-VII, and other group lymph

nodes, p16 positive with histology consistent with HPV-mediated oropharyngeal carcinoma

(OPC), are staged using the AJCC HPV-Mediated (p16+) Oropharyngeal Cancer Staging System.

Assign primary site C109; do NOT code this discriminator

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99999: Ill-Defined Other

If the tumor is not occult or does not have cervical metastasis in Levels I-VII, and other group

lymph nodes, it is not included in the AJCC Cervical Lymph Nodes and Unknown Primary Tumors

of the Head and Neck Staging System and will be classified as Ill-Defined Other for Summary

Staging

Note 2: If there is no evidence of the primary tumor, yet the physician “suspects” a specific head and

neck subsite, do not assign that primary site, but code C760 (see exceptions for EBV positive or p16

positive cancers.)

Code Description Schema ID #/Description

0 Not Occult 99999: Ill-Defined Other

00459: Soft Tissue Other (8941/3 only)

1 Occult, Negative cervical nodes (regional head

and neck nodes)

99999: Ill-Defined Other

00459: Soft Tissue Other (8941/3 only)

2 Not tested for EBV or p16 in head and neck

regional nodes (EBV and p16 both unknown)

00060: Cervical Lymph Nodes and

Unknown Primary

3 Unknown EBV, p16 negative in head and neck

regional nodes

00060: Cervical Lymph Nodes and

Unknown Primary

4 Unknown p16, EBV negative in head and neck

regional nodes

00060: Cervical Lymph Nodes and

Unknown Primary

5 Negative for both EBV and p16 in head and

neck regional nodes

00060: Cervical Lymph Nodes and

Unknown Primary

<Blank> Not C760, discriminator does not apply

Positive p16 in head and neck regional nodes,

EBV unknown or negative

Assign primary site C109

Positive EBV in head and neck regional nodes,

p16 positive, negative, or unknown

Assign primary site C119

Various

00010: Oropharynx HPV-Mediated (p16+)

00090: Nasopharynx

Return to Schema ID Table

53 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

Item Length: 1

NAACCR Item #: 3831

XML Parent-NAACCR ID: Tumor-extranodalExtensionHeadNeckClin

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00060: Cervical Lymph Nodes and Unknown Primary (2018+)

00071: Lip (2018+)

00072: Tongue Anterior (2018+)

00073: Gum (2018+)

00074: Floor of Mouth (2018+)

00075: Palate Hard (2018+)

00077: Mouth Other (2018+)

00080: Major Salivary Glands (2018+)

00090: Nasopharynx (2018+)

000100: Oropharynx HPV-Mediated (p16+)

00111: Oropharynx (p16-)

00112: Hypopharynx (2018+)

00121: Ethmoid Sinus (2018+)

00122: Nasal Cavity and Ethmoid Sinus (2018+)

00130: Larynx Other (2018+)

00131: Larynx Supraglottic (2018+)

00132: Larynx Glottic (2018+)

Description

Extranodal extension is defined as “the extension of a nodal metastasis through the lymph node capsule

into adjacent tissue” and is a prognostic factor for most head and neck tumors. This data item pertains

to clinical extension.

Rationale

Extranodal Extension Head and Neck Clinical is a Registry Data Collection Variable in AJCC. It was

previously collected as Head and Neck SSF #8 (Common SSF).

Definition

The presence of extranodal extension (ENE) from regional lymph nodes is an important prognostic factor

in some cancers because these patients are rarely cured without some type of systemic chemotherapy

or radiation. Extranodal extension is defined as metastatic tumor growing from within the lymph node

outward through the lymph node capsule and into surrounding connective tissues.

This data item for ENE detected clinically.

Coding guidelines

Code 0 when there are positive nodes clinically, but ENE not identified/not present.

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Code 1 when there are positive nodes clinically, ENE is identified by physical exam WITH or

WITHOUT imaging

Code 2 when there are positive nodes clinically, ENE is identified by biopsy (microscopically

confirmed)

Code 4 when there are positive nodes clinically, ENE is identified, but not known how identified

Code 7 when nodes are clinically negative (cN0)

Code 9 when

o No information in the medical record

o Positive nodes clinically, not evaluated (assessed) for ENE

o Positive nodes clinically, unknown if evaluated (assessed) for ENE

o Lymph nodes not evaluated (assessed) clinically

o Unknown if lymph nodes evaluated (assessed) clinically

Additional Information

Source documents: pathology report, imaging reports, physical exam

Other names: ENE, extracapsular extension, ECE

Coding Instructions and Codes

Note 1: Physician statement of extranodal extension (ENE) clinically or physician clinical stage indicating

the absence or presence of ENE can be used to code this data item when no other information is

available. Physical exam alone is sufficient to determine Clinical ENE.

Note 2: The assessment of ENE must be based on evidence acquired prior to definitive surgery of the

primary site, chemotherapy, radiation or other type of treatment, i.e., the clinical timeframe for staging.

The assessment for ENE in addition to physical examination may include imaging, biopsy of the

regional lymph node, and/or biopsy of tissues surrounding the regional lymph node.

Imaging alone is not enough to determine or exclude ENE.

Note 3: Be aware that the rules for coding ENE for head and neck sites compared to non-head and neck

sites are different.

Note 4: Code 0 when lymph nodes are determined to be clinically positive and physical examination

does not indicate any signs of extranodal extension.

Note 5: Code 1 when

ENE is unquestionable as determined by physical examination

o Clinical ENE is described in the AJCC Head and Neck Staging System as “Unambiguous

evidence of gross ENE on clinical examination (e.g., invasion of skin, infiltration of

musculature, tethering to adjacent structures, or cranial nerve, brachial plexus,

sympathetic trunk, or phrenic nerve invasion with dysfunction)”

The terms ‘fixed’ or ‘matted’ are used to describe lymph nodes

Other terms for ENE include: ‘extranodal spread’, ‘extracapsular extension’, or ‘extracapsular

spread’.

Note 6: Code 9 when physical exam is not available AND at least one of the following

No additional information

Statement of lymph node involvement with no information on ENE

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Lymph node biopsy (e.g., FNA, core, incisional, excisional, sentinel node) performed and is

negative for ENE or not stated

Code Description

0 Regional lymph nodes involved, ENE not present/not identified during diagnostic workup

1 Regional lymph nodes involved, ENE present/identified during diagnostic workup, based on

physical exam WITH or WITHOUT imaging

2 Regional lymph nodes involved, ENE present/identified during diagnostic workup, based on

microscopic confirmation

4 Regional lymph nodes involved, ENE present/identified, unknown how identified

7 No lymph node involvement during diagnostic workup (cN0)

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error)

9 Not documented in medical record

ENE not assessed during diagnostic workup, or unknown if assessed

Clinical assessment of lymph nodes not done, or unknown if done

Return to Schema ID Table

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3832: Extranodal Extension Head and Neck Pathological

Item Length: 3

NAACCR Item #: 3832

XML Parent-NAACCR ID: Tumor-extranodalExtensionHeadNeckPath

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00060: Cervical Lymph Nodes and Unknown Primary (2018+)

00071: Lip (2018+)

00072: Tongue Anterior (2018+)

00073: Gum (2018+)

00074: Floor of Mouth (2018+)

00075: Palate Hard (2018+)

00077: Mouth Other (2018+)

00080: Major Salivary Glands (2018+)

00090: Nasopharynx (2018+)

000100: Oropharynx HPV-Mediated (p16+)

00111: Oropharynx (p16-)

00112: Hypopharynx (2018+)

00121: Ethmoid Sinus (2018+)

00122: Nasal Cavity and Ethmoid Sinus (2018+)

00130: Larynx Other (2018+)

00131: Larynx Supraglottic (2018+)

00132: Larynx Glottic (2018+)

Description

Extranodal extension (ENE) is defined as “the extension of a nodal metastasis through the lymph node

capsule into adjacent tissue” and is a prognostic factor for most head and neck tumors. This data item

pertains to pathological staging extension.

Rationale

Extranodal Extension Head and Neck Pathological is a Registry Data Collection Variable in AJCC. It was

previously collected as Head and Neck SSF #9 (Common SSF).

Definition

The presence of extranodal extension (ENE) from regional lymph nodes is an important prognostic factor

in some cancers because these patients are rarely cured without some type of systemic chemotherapy

or radiation. Extranodal extension is defined as metastatic tumor growing from within the lymph node

outward through the lymph node capsule and into surrounding connective tissues.

This data item for ENE that is detected pathologically for head and neck primaries.

Coding guidelines

Code 0.0 when there are positive nodes pathologically, but ENE not identified/not present.

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Code the actual size of the ENE in the range 0.1-9.9 mm

Code X.1 when actual size of the ENE is 10 mm or greater

Code X.2 when stated to be microscopic [ENE (mi)]

Code X.3 when stated to be major [ENE (ma)]

Code X.4 when size not documented, unknown whether microscopic (mi) or major (ma)

Code X.7 when nodes are surgically resected, and they are negative (pN0)

Code X.9 when

o No information in the medical record

o Positive nodes pathologically, not evaluated (assessed) for ENE

o Positive nodes pathologically, unknown if evaluated (assessed) for ENE

o Lymph nodes not evaluated (assessed) pathologically (no surgical resection of lymph

nodes)

o Unknown if lymph nodes evaluated pathologically (assessed)

Additional Information

Source documents: pathology report from surgical resection

Other names: ENE, extracapsular extension, ECE

Coding Instructions and Codes

Note 1: Physician statement of extranodal extension (ENE) pathologically during a lymph node

dissection or physician pathological stage indicating the absence or presence of ENE can be used to code

this data item when no other information is available.

Note 2: Extranodal extension is defined as “the extension of a nodal metastasis through the lymph node

capsule into adjacent tissue.” ENE is the preferred terminology. Other names include: extranodal spread,

extracapsular extension, or extracapsular spread.

“A regional node extending into a distant structure or organ is categorized as ENE and is not

recorded as distant metastatic disease.”

Note 3: Code the status of ENE assessed on histopathologic examination of surgically resected involved

regional lymph node(s). Do not code ENE from a lymph node biopsy (FNA, core, incisional, or the

absence of ENE from a sentinel). Do not code ENE for any distant lymph nodes. Code the status of ENE

based on the following criteria

Code 0.0

o Absence of ENE, positive lymph nodes assessed by lymph node dissection

o 1292: Scope of Regional Lymph Node Surgery must be 3-7

Codes 0.1-9.9, X.1, X.2, X.3, X.4 as appropriate for

o Presence of ENE assessed by Sentinel Lymph Node biopsy

o Presence of ENE assessed by lymph node biopsy

o 1292: Scope of Regional Lymph Node Surgery must be 2-7

Code X.7 as appropriate for

o Lymph nodes negative for cancer assessed by Sentinel lymph node biopsy or lymph

node dissection

o 1292: Scope of Regional Lymph Node Surgery must be 2-7

Code X.9

o Absence of ENE, positive lymph nodes assessed by Sentinel Lymph Node biopsy

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A positive Sentinel Lymph Node biopsy cannot assess the absence of ENE, only

the presence of it. This is because there is not enough surrounding tissue in a

Sentinel Lymph node biopsy to accurately assess ENE

If codes 0.1-0.9, X.1-X.7 are used, this indicates that the lymph nodes were surgically resected or

a Sentinel Lymph Node biopsy was done and Scope of Regional Lymph Node Surgery [NAACCR

Data Item: 1292] must be 2-7

Note 4: Be aware that the rules for coding ENE for head and neck sites compared to non-head and neck

sites are different.

Note 5: Definitions of ENE subtypes and rules:

Microscopic ENE [ENE (mi)] is defined as less than or equal to 2 mm.

Major ENE [ENE (ma)] is defined as greater than 2 mm.

Both ENE (mi) and ENE (ma) qualify as ENE (+) for definition of pN.

Note 6: The measurement of ENE is the distance from the lymph node capsule in millimeters (mm).

Code Description

0.0 Lymph nodes positive for cancer but ENE not identified or negative

0.1-9.9 ENE 0.1 to 9.9 mm

X.1 ENE 10 mm or greater

X.2 ENE microscopic, size unknown

Stated as ENE (mi)

X.3 ENE major, size unknown

Stated as ENE (ma)

X.4 ENE present, microscopic or major unknown, size unknown

X.7 Surgically resected regional lymph nodes negative for cancer (pN0)

X.8

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X.8 may result in an edit error)

X.9 Not documented in medical record

No surgical resection of regional lymph nodes

ENE not assessed pathologically, or unknown if assessed

Pathological assessment of lymph nodes not done, or unknown if done

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other)

For head and neck sites, regional lymph node information is coded in several different data items.

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

The Head and Neck Levels are defined as

1. Level I is subdivided into levels IA and IB, which contain the submental and submandibular

triangles bounded by the anterior and posterior bellies of the digastric muscle, the hyoid bone

inferiorly, and the body of the mandible superiorly. Lymph node chains at this level:

Submental (Level IA), submandibular (Level IB), submaxillary (Level IB)

2. Level II is subdivided into levels IIA and IIB, which contain the upper jugular lymph nodes and

extend from the level of the skull base superiorly to the hyoid bone inferiorly. A vertical plane

defined by the spinal accessory nerve is the boundary between level IIA (anterior to spinal

accessory nerve) and IIB (posterior to spinal accessory nerve). Lymph node chains at this level:

Jugulodigastric (subdigastric), upper deep cervical, upper jugular

3. Level III contains the middle jugular lymph nodes from the hyoid bone superiorly to the level of

the lower border of the cricoid cartilage inferiorly. Lymph node chains at this level:

Middle deep cervical, mid-jugular

4. Level IV contains the lower jugular lymph nodes from the level of the cricoid cartilage superiorly

to the clavicle inferiorly. Lymph node chains at this level:

Jugulo-omohyoid (supraomohyoid), lower deep cervical, lower jugular

5. Level V is subdivided into levels VA and VB, which contain the lymph nodes in the posterior

triangle bounded by the anterior border of the trapezius muscle posteriorly, the posterior

border of the sternocleidomastoid muscle anteriorly, and the clavicle inferiorly. For descriptive

purposes, Level V may be further subdivided into upper (VA) and lower (VB) levels

corresponding to a plane defined by the inferior border of the cricoid cartilage. Lymph node

chains at this level:

Posterior cervical, posterior triangle (spinal accessory, transverse cervical [upper,

middle, and lower, corresponding to the levels that define upper, middle, and lower

jugular nodes]), supraclavicular

6. Level VI contains the lymph nodes of the anterior central compartment from the hyoid bone

superiorly to the suprasternal notch inferiorly. On each side, the lateral boundary is formed by

the medial border of the carotid sheath. Lymph node chains at this level:

Laterotracheal, Paralaryngeal, paratracheal (above suprasternal notch), perithyroidal,

Precricoid (Delphian), Prelaryngeal, recurrent laryngeal)

7. Level VII contains the lymph nodes inferior to the suprasternal notch in the superior

mediastinum. Lymph node chains at this level:

Esophageal groove, paratracheal (below suprasternal notch), Pretracheal (below

suprasternal notch)

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8. Other head and neck lymph nodes:

Cervical, NOS; deep cervical (NOS), facial, buccinator (buccal), infraauricular, internal

jugular (NOS), intraparotid, mandibular, nasolabial, parapharyngeal, parotid,

periparotid, preauricular, retroauricular (mastoid), retropharyngeal, suboccipital

Coding guidelines

Example 1: A carcinoma of the base of tongue involves bilateral submandibular nodes and left

upper, mid-, and lower jugular nodes, the largest measuring 4 cm. There is no extracapsular

extension. These are level I, II, III, and IV lymph nodes according to AJCC definitions.

Levels I-III: Code 7 (Levels I, II and III lymph nodes involved) to show that levels I, II, and

III are involved

Levels IV-V: Code 1 to show that level IV is involved

Levels VI-VII: Code 0 for no other nodes involved

Head and Neck, Other: Code 0 for no other nodes involved

Example 2: Patient diagnosed elsewhere with carcinoma of oropharynx with cervical lymph

node involvement. No other information available. All Head and Neck Level data items are

coded to 9 since there is no specific information about the levels.

Levels I-III: Code 9

Levels IV-V: Code 9

Levels VI-VII: Code 9

Head and Neck, Other: Code 9

Coding NOS

Note: When the only information available is “Regional nodes, NOS” or “Cervical nodes, NOS” or

“Internal jugular nodes, NOS” or “Lymph nodes, NOS,” code 9. In other words, if regional nodes

are known to be positive but the level(s) of nodes involved is unknown, code 9.

Coding a Node That Overlaps Two Levels

Note: If a lymph node is described as involving two levels, code both levels.

o Example: Physical examination for a floor of mouth cancer describes a large lymph node

mass low in level II stretching into Level III. Code 6 for Levels II-III because both Level II

and Level III are mentioned.

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3876: LN Head and Neck Levels I-III

Item Length: 1

NAACCR Item #: 3876

XML Parent-NAACCR ID: Tumor-lnHeadAndNeckLevels1To3

NAACCR Alternate Name: Lymph Nodes Head and Neck Levels I-III

Active years: 2018+

Schemas(s):

00060: Cervical Lymph Nodes and Unknown Primary (2018+)

00140: Melanoma Head and Neck (2018+)

Description

Lymph Nodes for Head and Neck, Levels I-III records the involvement of Levels I-III lymph nodes.

Rationale

Level of nodal involvement is a Registry Data Collection Variable in AJCC for several head and neck

chapters. This data item was previously collected as Head and Neck SSF #3 (common SSF).

Definition

This data item is used to code the presence or absence of lymph node involvement in head and neck

levels I-III. The definitions of the levels are the same for all applicable head and neck sites.

Note: This data item was previously collected for all head and neck sites. It is now only clinically

relevant for unknown head and neck primaries with positive cervical (head and neck) lymph

nodes and mucosal melanomas of the head and neck.

See 3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Levels I-III lymph node involvement can be used to code this data item

when no other information is available.

Note 2: Head and Neck Lymph Node Involvement is coded in the following data items

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

Note 3: Code the presence or absence of lymph node involvement for Levels I-III.

For more information on Levels I-III lymph nodes, see AJCC 8

edition, Chapter 5: Staging Head

and Neck Cancers, Table 5.1

Note 4: Pathological information takes priority over clinical.

Note 5: If involved regional node levels are documented as a range, or if the involved nodes overlap

multiple levels, code all levels specified.

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Note 6: If information is available on some nodes, but the others are unknown, code what is known.

Example: Multiple lymph nodes involved, level II documented, but the other levels not

mentioned. Code 2 to indicate level II involvement.

Code Description

0 No involvement in Levels I, II, or III lymph nodes

Level I lymph node(s) involved

2 Level II lymph node(s) involved

3 Level III lymph node(s) involved

4 Levels I and II lymph nodes involved

5 Levels I and III lymph nodes involved

6 Levels II and III lymph nodes involved

7 Levels I, II and III lymph nodes involved

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error)

9 Not documented in medical record

Positive nodes, but level of positive node(s) unknown

Lymph node levels I-III not assessed, or unknown if assessed

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3877: LN Head and Neck Levels IV-V

Item Length: 1

NAACCR Item #: 3877

XML Parent-NAACCR ID: Tumor-lnHeadAndNeckLevels4To5

NAACCR Alternate Name: Lymph Nodes Head and Neck Levels IV-V

Active years: 2018+

Schemas(s):

00060: Cervical Lymph Nodes and Unknown Primary (2018+)

00140: Melanoma Head and Neck (2018+)

Description

Lymph Nodes for Head and Neck, Levels IV-V records the involvement of Levels IV-V lymph nodes.

Rationale

Level of nodal involvement is a Registry Data Collection Variable in AJCC. This data item was previously

collected as Head and Neck SSF #4 (common SSF).

Definition

This data item is used to code the presence or absence of lymph node involvement in head and neck

levels IV-V. The definitions of the levels are the same for all applicable head and neck sites.

Note: This data item was previously collected for all head and neck sites. It is now only clinically

relevant for unknown head and neck primaries with positive cervical (head and neck) lymph

nodes and mucosal melanomas of the head and neck.

See 3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Levels IV-V lymph node involvement can be used to code this data item

when no other information is available.

Note 2: Head and Neck Lymph Node Involvement is coded in the following data items

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

Note 3: Code the presence or absence of lymph node involvement for Levels IV-V.

For more information on Levels IV-V lymph nodes, see AJCC 8

edition, Chapter 5: Staging Head

and Neck Cancers, Table 5.1

Note 4: If lymph nodes are described only as “supraclavicular,” try to determine if they are in Level IV

(deep to the sternocleidomastoid muscle, in the lower jugular chain) or Level V (in the posterior triangle,

inferior to the transverse cervical artery) and code appropriately.

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If the specific level cannot be determined, or is documented as supraclavicular with no further

information, code them as Level V nodes

Note 5: Pathological information takes priority over clinical.

Note 6: If involved regional node levels are documented as a range, and/or if the involved nodes overlap

multiple levels, code all levels specified.

Note 7: If information is available on some nodes, but the others are unknown, code what is known.

Example: Multiple lymph nodes involved, level V documented, but the other levels not

mentioned. Code 2 to indicate level V involvement.

Code Description

0 No involvement in Levels IV or V lymph nodes

1 Level IV lymph node(s) involved

2 Level V lymph node(s) involved

3 Levels IV and V lymph node(s) involved

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error)

9 Not documented in medical record

Positive nodes, but level of positive node(s) unknown

Lymph node levels IV-V not assessed, or unknown if assessed

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3878: LN Head and Neck Levels VI-VII

Item Length: 1

NAACCR Item #: 3878

XML Parent-NAACCR ID: Tumor-lnHeadAndNeckLevels6To7

NAACCR Alternate Name: Lymph Nodes Head and Neck Levels VI-VII

Active years: 2018+

Schemas(s):

00060: Cervical Lymph Nodes and Unknown Primary

00140: Melanoma Head and Neck

Description

Lymph Nodes for Head and Neck, Levels VI-VII records the involvement of Levels VI-VII lymph nodes.

Rationale

Level of nodal involvement is a Registry Data Collection Variable in AJCC. This data item was previously

collected as Head and Neck SSF #5 (common SSF).

Definition

This data item is used to code the presence or absence of lymph node involvement in head and neck

levels VI and VII. The definitions of the levels are the same for all applicable head and neck sites.

Note 1: This data item was previously collected for all head and neck sites. It is now only

clinically relevant for unknown head and neck primaries with positive cervical (head and neck)

lymph nodes and mucosal melanomas of the head and neck.

Note 2: In Collaborative Stage v2 (CSv2), Facial Lymph Nodes were collected with Levels VI-VII.

They have now been moved to the “other” group.

See 3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Levels VI-VII lymph node involvement can be used to code this data item

when no other information is available.

Note 2: Head and Neck Lymph Node Involvement is coded in the following data items

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

Note 3: Code the presence or absence of lymph node involvement for Levels VI-VII.

For more information on Levels VI-VII lymph nodes, see AJCC 8

edition, Chapter 5: Staging

Head and Neck Cancers, Table 5.1

Note 4: Pathological information takes priority over clinical.

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Note 5: If involved regional node levels are documented as a range, or if the involved nodes overlap

multiple levels, code all levels specified.

Note 6: If information is available on some nodes, but the others are unknown, code what is known.

Example: Multiple lymph nodes involved, level VI documented, but the other levels not

mentioned. Code 1 to indicate level VI involvement.

Code Description

0 No involvement in Levels VI or VII lymph nodes

1 Level VI lymph node(s) involved

2 Level VII lymph node(s) involved

3 Levels VI and VII lymph node(s) involved

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error)

9 Not documented in medical record

Positive nodes, but level of positive node(s) unknown

Lymph nodes levels VI-VII not assessed, or unknown if assessed

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3879: LN Head and Neck Other

Item Length: 1

NAACCR Item #: 3879

XML Parent-NAACCR ID: Tumor-lnHeadAndNeckOther

NAACCR Alternate Name: Lymph Nodes Head and Neck Other

Active years: 2018+

Schemas(s):

00060: Cervical Lymph Nodes and Unknown Primary

00140: Melanoma Head and Neck

Description

Lymph Nodes for Head and Neck, Other records the involvement of lymph nodes other than Levels I-III,

IV-V, and VI-VII.

Rationale

Level of nodal involvement is a Registry Data Collection Variable in AJCC. This data item was previously

collected as Head and Neck SSF #6 (common SSF).

Definition

This data item is used to code the presence or absence of lymph node involvement for other head and

neck lymph nodes. The definitions of the levels are the same for all applicable head and neck sites.

Note 1: This data item was previously collected for all head and neck sites. It is now only

clinically relevant for unknown head and neck primaries with positive cervical (head and neck)

lymph nodes and mucosal melanomas of the head and neck.

Note 2: In Collaborative Stage v2 (CSv2), Facial Lymph Nodes were collected with Levels VI-VII.

They are now collected with the “other” lymph nodes.

See 3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of other head and neck lymph node involvement can be used to code this

data item when no other information is available.

Note 2: Head and Neck Lymph Node Involvement is coded in the following data items

3876: LN Head and Neck Levels I-III

3877: LN Head and Neck Levels IV-V

3878: LN Head and Neck Levels VI-VII

3879: LN Head and Neck Other

Note 3: Code the presence or absence of lymph node involvement for the “other” group.

For more information on the other head and neck lymph nodes, see AJCC 8

edition, Chapter 5:

Staging Head and Neck Cancers, Table 5.1

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Note 4: Pathological information takes priority over clinical.

Note 5: If involved regional node levels are documented as a range, and/or if the involved nodes overlap

multiple levels, code 7.

Note 6: If information is available on some nodes, but the others are unknown, code what is known.

Example: Multiple lymph nodes involved, preauricular documented, but the other levels not

mentioned. Code 4 to indicate preauricular involvement.

Code Description

0 No involvement in other head and neck lymph node regions

1 Buccinator (facial) lymph node(s) involved

2 Parapharyngeal lymph node(s) involved

3 Periparotid and intraparotid lymph node(s) involved

4 Preauricular lymph node(s) involved

Retropharyngeal lymph node(s) involved

Suboccipital/retroauricular lymph node(s) involved

7 Any combination of codes 1-6

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Positive nodes, but level of positive node(s) unknown

Other Head and Neck lymph nodes not assessed, or unknown if assessed

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00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3883: LN Size

Item Length: 4

NAACCR Item #: 3883

XML Parent-NAACCR ID: Tumor-lnSize

NAACCR Alternate Name: Lymph Nodes Size

Active years: 2018+

Schema(s):

00060: Cervical Lymph Nodes and Unknown Primary

00071: Lip

00072: Tongue Anterior

00073: Gum

00074: Floor of Mouth

00075: Palate Hard

00076: Buccal Mucosa

00077: Mouth Other

00080: Major Salivary Glands

00090: Nasopharynx

00100: Oropharynx HPV-Mediated (p16+)

00111: Oropharynx (p16-)

00112: Hypopharynx

00121: Maxillary Sinus

00122: Nasal Cavity and Ethmoid Sinuses

00130: Larynx Other

00131: Larynx SupraGlottic

00132: Larynx Glottic

00133: Larynx SubGlottic

00140: Melanoma Head and Neck

00150: Cutaneous Carcinoma of Head and Neck

Description

Lymph Nodes Size records diameter of the involved regional lymph node(s) with the largest diameter of

any involved regional lymph node(s). Pathological measurement takes precedence over a clinical

measurement for the same node.

Rationale

Lymph Nodes Size is a Registry Data Collection Variable in AJCC for several chapters. It was previously

collected in the Head and Neck chapters as Size of Lymph Nodes, SSF #1.

Definition

This data item is used to code the size of involved lymph nodes and is recorded in millimeters.

Coding guidelines

Code the largest diameter of any involved regional lymph nodes for head and neck (cervical lymph

nodes). The measurement can be pathological, if available, or clinical.

Code 0.0 when no regional lymph nodes are involved

Code XX.1 for 100 millimeters (10 cm) or greater

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Code XX.2 for microscopic focus or foci only and no size of focus given

Code XX.3 for lymph node met less than 1 cm (10 mm)

o Lymph node described as “subcentimeter)

Code XX.9 when

o Positive lymph nodes but size not stated

o No information about regional lymph nodes

o Lymph nodes not assessed or unknown if assessed

In order to align with the CAP guidelines, additional codes have been added for “at least” categories

which are used in the CAP protocols. Only use these codes when the pathologist has used this

terminology to indicate the lymph node size.

XX.4: Describes a lymph node size at least 2 cm (20 mm)

XX.5: Described a lymph node size at least 3 cm (30 mm)

XX.6: Describes a lymph node size at least 4 cm (40 mm)

XX.7: Describes a lymph node size 5 cm (50 mm) or greater

Coding Instructions and Codes

Note 1: Physician statement of Lymph Nodes Size can be used to code this data item when no other

information is available.

Note 2: If the same largest involved node (or same level) is examined both clinically and pathologically,

record the size of the node from the pathology report, even if it is smaller.

Example: Clinical evaluation shows 1.5 cm (15 mm) Level II lymph node, pathological

examination shows Level II 1.3 cm (13 mm). Code 13.0.

Note 3: If the largest involved node is not examined pathologically, use the clinical node size.

Note 4: Do not code the size of any distant nodes.

Code Description

0.0 No regional lymph node involvement

Non-invasive neoplasm (behavior /2)

0.1-99.9 0.1 – 99.9 millimeters (mm)

(Exact size of lymph node to nearest tenth of a mm)

XX.1 100 millimeters (mm) or greater

XX.2 Microscopic focus or foci only and no size of focus given

XX.3 Described as "less than 1 centimeter (cm)" or “subcentimeter”

XX.4 Described as "at least” 2 cm

XX.5 Described as "at least” 3 cm

XX.6 Described as "at least” 4 cm

XX.7 Described as greater than 5 cm

XX.8

Not applicable: Information not

collected for this case

(If this item is required by your standard setter, use of code XX.8 will result in an edit error)

XX.9 Not documented in medical record

Regional lymph node(s) involved, size not stated

Lymph Nodes Size not assessed, or unknown if assessed

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00071: Lip (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00072: Tongue Anterior (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00073: Gum (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00074: Floor of Mouth (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00075: Palate Hard (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

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00076: Buccal Mucosa (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00077: Mouth Other (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00080: Major Salivary Glands (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00090: Nasopharynx (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

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00090: Nasopharynx (2018+)

3926: Schema Discriminator 1: Nasopharynx/Pharyngeal Tonsil

Primary site C111 only

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00090: Nasopharynx

00100: Oropharynx HPV-Mediated (p16+)

00111: Oropharynx (p16-)

Definition

Nasopharynx and pharyngeal tonsil have the same ICD-O topography code (C111). However, for

purposes of stage grouping AJCC 8

edition, nasopharynx and pharyngeal tonsil are staged in different

chapters. A schema discriminator is necessary to distinguish between these primary sites so that the

appropriate chapter/schema is used.

Coding Instructions and Codes

Note: A schema discriminator is used to discriminate for primary site C111: Posterior wall of

nasopharynx. Code the specific site in which the tumor arose.

00090: Nasopharynx (see code 1)

Used to stage for the following primary site description: posterior wall of nasopharynx (NOS)

00100 (Oropharynx HPV-Mediated (p16+)) or 00111 (Orpharynx (p16-)) (see code 2)

Oropharynx Staging Systems are used for the following primary site descriptions. An additional

schema discriminator will be used to distinguish between the AJCC HPV-Mediated (p16+)

Oropharyngeal Cancer and Oropharynx (p16-) and Hypopharynx Staging System

o Adenoid

o Pharyngeal tonsil

Code Description Schema ID #/Description

1 Posterior wall of nasopharynx, NOS 00090: Nasopharynx

2 Adenoid

Pharyngeal tonsil

3927: Schema discriminator 2:

Oropharyngeal p16

<Blank> Primary Site is NOT C111, Discriminator is not necessary

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00100: Oropharynx HPV-Mediated (p16+) (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

See 00090: Nasopharynx (2018+)

3926: Schema Discriminator 1: Nasopharynx/Pharyngeal Tonsil

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00100: Oropharynx HPV-Mediated (p16+) (2018+)

3927: Schema Discriminator 2: Oropharyngeal p16

Item Length: 1

NAACCR Item #: 3927

XML Parent-NAACCR ID: Tumor-schemaDiscriminator2

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00100: Oropharynx HPV-Mediated (p16+)

00111: Oropharynx (p16-)

Definition

Staging for oropharyngeal cancers changed in the AJCC 8

edition. Chapter 10 is now for p16+ tumors,

while Chapter 11 is for p16- negative tumors or where the p16 is not assessed or unknown. A schema

discriminator is necessary to determine the p16 status so that the appropriate chapter/schema is used.

Coding Instructions and Codes

Note 1: A schema discriminator is used to discriminate between oropharyngeal tumors that are p16

positive and oropharyngeal tumors that are p16 negative OR p16 status unknown.

Note 2: Only the HPV p16+ test can be used. If another HPV test is done, code 9.

00100: Oropharynx HPV-Mediated (p16+) (see code 2)

o Used for p16 (+) (positive)

00111: Oropharynx (p16-)

o p16 expression of weak intensity or limited distribution (see code 1)

o p16 without an immunostain performed (see code 9)

Code

Description

Schema ID#/Description

1 p16 Negative; Nonreactive 00111: Orpharynx (p16-)

2 p16 Positive; HPV Positive; Diffuse, Strong reactivity 00100: Oropharynx HPV-Mediated

(p16+)

9 Not tested for p16; Unknown 00111: Orpharynx (p16-)

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00111: Oropharynx (p16-) (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

See 00090: Nasopharynx (2018+)

3926: Schema Discriminator 1: Nasopharynx/Pharyngeal Tonsil

See 00100: Oropharynx HPV-Mediated (p16+)

3927: Schema Discriminator 2: Oropharyngeal p16

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00112: Hypopharynx (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00121: Maxillary Sinus (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00122: Nasal Cavity and Ethmoid Sinuses (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00130: Larynx Other (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00131: Larynx Supraglottic (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00132: Larynx Glottic (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

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00133: Larynx SubGlottic (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3883: LN Size

00140: Mucosal Melanoma of the Head and Neck (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3831: Extranodal Extension Head and Neck Clinical

3832: Extranodal Extension Head and Neck Pathological

3876-3879: Head and Neck Regional Lymph Nodes (Levels I-VII, Other)

o 3876: LN Head and Neck Levels I-III

o 3877: LN Head and Neck Levels IV-V

o 3878: LN Head and Neck Levels VI-VII

o 3879: LN Head and Neck Other

00150: Cutaneous Carcinoma of the Head and Neck (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3883: LN Size

See 00200: Colon and Rectum for the following data item

3909: Perineural Invasion

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00150: Cutaneous Carcinoma of the Head and Neck (2018+)

3858: High Risk Histologic Features

Item Length: 1

NAACCR Item #: 3858

XML Parent-NAACCR ID: Tumor-highRiskHistologicFeatures

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00150: Cutaneous Carcinoma of Head and Neck (2018+)

Description

High Risk Histologic Features are defined in AJCC 8 Chapter 15 to include the terms “poor

differentiation, desmoplasia, sarcomatoid differentiation, undifferentiated.” High risk histologic

features are a prognostic factor for cutaneous cell carcinomas of the head and neck.

Rationale

High Risk Histologic Features is a Registry Data Collection Variable in AJCC. It was previously collected as

Skin, CS SSF # 12.

Definition

In addition to the tumor size (diameter, not depth), the presence of certain specific high-risk features is

of prognostic significance for skin cancers of the head and neck.

In Collaborative Stage v2 (CSv2), which was based on AJCC 7

edition, the number of high risk features

impacted the assignment of T. This is no longer the case. The type of high risk feature is now recorded

instead of the number.

Coding guidelines

Record the presence of high-risk features

Code 1 for desmoplasia

Code 2 for poor differentiation (grade 3)

Code 3 for sarcomatoid differentiation (features)

Code 4 for undifferentiated (grade 4)

Code 5 when more than one feature is present

Code 6 when high risk features are present, but it is not specified which one

Code 9 when

o Not documented in medical record

o High risk features not evaluated (assessed)

o Unknown if high-risk features evaluated (assessed)

Additional Information

Source documents: pathology report, consultation report, other statements in the medical

record

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Other names: high risk histologic features, high risk tumor features

Coding Instructions and Codes

Note 1: Physician statement of high risk histologic features can be used to code this data item when no

other information is available.

Note 2: High risk histologic features include

Desmoplasia

Poor differentiation (grade 3)

Sarcomatoid differentiation (features)

Undifferentiated (grade 4)

Note 3: Code the presence or absence of high risk histologic features as documented in the pathology

report.

Note 4: Code 5 if more than one high risk histologic feature is present.

Code Description

No high risk histologic features

Non-invasive neoplasm (behavior /2)

1 Desmoplasia

2 Poor differentiation (grade 3)

3 Sarcomatoid differentiation

4 Undifferentiated (grade 4)

5 Multiple high risk histologic features

6 Histologic features, NOS (type of high risk histologic feature not specified)

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error)

Not documented in medical record

High risk histologic features not assessed or unknown if assessed

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GASTROINTESTINAL TRACT (UPPER AND LOWER)

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00161: Esophagus (including GE junction) Squamous (2018+)

3926: Schema Discriminator 1: EsophagusGEJunction (EGJ)/Stomach

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00161: Esophagus (including GE junction) Squamous (2018+)

00169: Esophagus (including GE junction) (excluding Squamous) (2018+)

00170: Stomach (2018+)

Definition

The esophagus chapter of the AJCC Cancer Staging Manual 8

edition includes the esophagogastric

junction (also called the cardia or gastroesophageal junction) and the proximal 2 cm of the stomach. The

cardia is defined as the opening or junction between the esophagus and the stomach, and it is between

0.1 and 0.4 cm in length. This 2-cm boundary measurement is based on the Siewert classification of

gastroesophageal cancers, which defines an area 2 cm above and 2 cm below the cardia or

esophagogastric junction. Both of these areas are coded to primary site C160, so a discriminator is

needed to get to the correct chapter.

Note: This is different from AJCC 7

edition (CSv2) where the measurement was 5 cm.

To determine whether a cancer of the cardia should be coded according to the esophagus schema or the

stomach system, it is necessary to identify the midpoint or epicenter of the tumor. If the midpoint is at

or above the cardia, the tumor is esophageal. If the midpoint of the tumor is within 2 cm distal to the

gastroesophageal junction (GEJ) and the lesion extends to or across the GEJ, the case should be coded

with the esophagus system. If the midpoint of the tumor is within 2 cm distal to the GEJ and the lesion

does not extend to the GEJ, the case should be coded with the stomach schema. Any tumor with a

midpoint more distal than 2 cm from the GEJ is coded with the stomach schema.

Select the code that best describes the location and extent of the tumor, and the computer

algorithm will bring the correct schema to the screen

Coding Notes and Instructions

Note 1: Under primary site code C160, there are two different structures that are staged differently.

Esophagogastric junction (Esophagus Schemas)

Cardia of the Stomach (Stomach schema)

Note 2: The gastroesophageal junction (GEJ) (primary site C160) is a poorly defined anatomic area that

represents the junction between the distal esophagus and the proximal stomach (cardia). The true

anatomic GEJ corresponds to the most proximal aspect of the gastric folds, which represents an

endoscopically apparent transition point in most individuals.

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Note 3: The cardia (also assigned primary site C160) is the first part of the stomach. It is the region

where the stomach meets the end of the esophageal tube. This region is also referred to as the Z-line or

the esophagogastric junction.

Note 4: Physician's statement can be used to code this data item when no other information is available.

Example: Patient diagnosed with tumor involving the cardia. No other information available.

Physician stages the patient using the Esophagus Staging System/CAP protocol

o Answer: Code 2 based on physician using the Esophagus Staging System

Note 5: Tumors with their midpoint (epicenter) in the GE Junction are staged as Esophagus, while

tumors with their midpoint (epicenter) in the cardia/stomach are staged using the Stomach Staging

System.

Note: The CAP protocol uses "midpoint" instead of "epicenter." This is the pathologist's

assessment of the point of tumor origin, regardless of tumor extension into other tissues.

Chapter 16: Esophagus and Esophagogastric Junction (see code 2)

Note 1: Use code 2 when

EGJ is documented as involved and the midpoint (epicenter) is within the proximal (above) 2 cm

of the cardia

EGJ is documented as involved and there is no mention of extension into the stomach or

stomach involvement

Example 1: MRI: Findings most consistent with metastatic GE junction cancer. Upper EUS:

Medium-sized, fungating, polypoid and ulcerated mass with no active bleeding was found in the

gastric cardia extending from GEJ to 42 cm from incisors. One malignant-appearing lymph node

was visualized in the peripancreatic region.

o Answer: Code 2 for involvement of the GE Junction/Cardia and no mention of

involvement of the stomach

EGJ is documented as involved and there is no information on stomach involvement and

o Esophagus CAP Protocol is used OR

o Esophagus Staging System is used

o If the CAP Protocol and AJCC Staging System are different, default to the AJCC Staging

System

Chapter 17: Stomach (see codes 0, 3, and 9)

Note 1: Use code 0 when only the cardia is documented as involved (no mention of EGJ)

Note 2: Use code 3 when

EGJ is documented as involved and the midpoint (epicenter) is more than 2 cm distal (below)

from the EGJ

EGJ is documented as involved and there is no information on stomach involvement AND

o Stomach CAP Protocol is used OR

o Stomach AJCC Staging System is used

o If the CAP Protocol and AJCC Staging System are different, default to the AJCC Staging

System

Note 3: Use code 9 when there is no documentation regarding EGJ involvement.

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Code Description Schema ID#/Description

0 NO involvement of esophagus or gastroesophageal junction

AND epicenter at ANY DISTANCE into the proximal stomach

(including distance unknown)

00170: Stomach

INVOLVEMENT of esophagus or esophagogastric junction (EGJ)

AND epicenter LESS THAN OR EQUAL TO 2 cm into the proximal

stomach

OR no stated involvement of or into the stomach

00161

, 00169: Esophagus

Schemas

AND go to Schema

Discriminator 2: Histology

Discriminator for 8020/3

INVOLVEMENT of esophagus or esophagogastric junction (EGJ)

AND epicenter GREATER THAN 2 cm into the proximal stomach

00170: Stomach

9 UNKNOWN involvement of esophagus or gastroesophageal junction

AND epicenter at ANY DISTANCE into the proximal stomach

(including distance unknown)

00170: Stomach

<Blank> Primary site is NOT C160, Discriminator is not necessary

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00161: Esophagus (including GE junction) Squamous (2018+)

3927: Schema Discriminator 2: Histology Discriminator for 8020/3

Item Length: 1

NAACCR Item #: 3927

XML Parent-NAACCR ID: Tumor-schemaDiscriminator2

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00161: Esophagus (including GE junction) Squamous (2018+)

00169: Esophagus (including GE junction) (excluding Squamous) (2018+)

Definition

Histology code 8020/3 is defined as “undifferentiated carcinoma.” In the AJCC 8

chapter for Esophagus,

this histology code is further subdivided into squamous or glandular component, which are staged

differently. A schema discriminator is necessary to distinguish between these histologies so that the

appropriate stage group table is used.

Coding Instructions and Codes

Note: A schema discriminator is used to discriminate for histology 8020/3: Undifferentiated carcinoma

to determine which AJCC Stage Group table to use.

8020/3: Undifferentiated carcinoma with squamous component (see code 1)

o Use the Squamous Cell Carcinoma AJCC Stage Group

8020/3: Undifferentiated carcinoma with glandular component (see code 2)

o Use the Adenocarcinoma AJCC Stage Group Table

8020/3: Undifferentiated carcinoma, NOS (no mention of squamous or glandular component)

(see code 3)

o Use the Squamous Cell Carcinoma AJCC Stage Group Table

Code Description Schema ID#/Description

1 Undifferentiated carcinoma with squamous component

00161: Esophagus (including GE

junction) Squamous

2 Undifferentiated carcinoma with glandular component

00169: Esophagus (including GE

junction) (excluding Squamous)

9 Undifferentiated carcinoma, NOS

00161: Esophagus (including GE

junction) Squamous

<Blank> Histology is NOT 8020, Discrminator is not necessary

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00161: Esophagus and Esophagogastric Junction (2018+)

3829: Esophagus and EGJ Tumor Epicenter

Item Length: 1

NAACCR Item #: 3829

XML Parent-NAACCR ID: Tumor-esophagusAndEgjTumorEpicenter

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00161: Esophagus (including GE junction) Squamous (2018+)

Required for Staging: The AJCC Esophagus Staging System and EOD, for Squamous Cell Carcinomas only

Description

Esophagus and Esophagogastric Junction (EGJ), Squamous Cell (including adenosquamous), Tumor

Location refers to the position of the epicenter of the tumor in the esophagus.

Rationale

This data item is required for prognostic stage grouping for squamous and adenosquamous carcinoma in

AJCC 8

edition, Chapter 16 Esophagus and Esophagogastric Junction. It is a new data item for cases

diagnosed 1/1/2018 and forward.

Coding Instructions and Codes

Note 1: This data item is used for pathological staging for squamous cell carcinoma of the esophagus

and esophagogastric junction. If information is available for clinical staging, record it.

Note 2: Location is defined by the position of the epicenter of the tumor in the esophagus.

Information is most likely to be obtained from pathological exam, scopes, operative notes or CT scans.

The epicenter of the lesion is used to describe location.

Example: If the lesion was from 15-21 cm, this is a 6-cm lesion with epicenter at 18 cm. It is the

midpoint.

Note 3: Clinician or pathologist statement of epicenter being the upper, middle, or lower takes priority

over any individual results or measurements. If no statement of epicenter is provided indicating upper,

middle, or lower is provided, the following measurements may be used.

15-24 cm from incisors = upper

25-29 cm from incisors = middle

30-40/45 cm from incisors = lower

Note 4: Additional information about the epicenter may be found in Chapter 16, Esophagus and

Esophagogastric Junction, Table 16.1 and Figure 16.1.

Note 5: The ascertainment of the epicenter of the tumor is for staging purposes and is separate from the

assignment of the ICD-O-3 topography code. If you have an overlapping tumor (C158), do not recode the

topography based on the epicenter.

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Note 6: If primary site is C259 (Esophagus, NOS), code 9.

Code Description

0 U: Upper (Cervical/Proximal esophagus to lower border of azygos vein)

1 M: Middle (Lower border of azygos vein to lower border of inferior pulmonary vein)

2 L: Lower (Lower border of inferior pulmonary vein to stomach, including

gastroesophageal junction)

9 X: Esophagus, NOS

Specific location of epicenter not documented in medical record

Specific location of epicenter not assessed or unknown if assessed

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00161: Esophagus (including GE junction) Squamous (2018+)

3855: HER2 Overall Summary

Item Length: 1

NAACCR Item #: 3855

XML Parent-NAACCR ID: Tumor-her2OverallSummary

NAACCR Alternate Name: None

Active years: 2021+

Schema(s):

00161: Esophagus (including GE junction) Squamous (2018+)

00169: Esophagus (including GE junction) (excluding Squamous) (2018+)

00170: Stomach (2018+)

Description

HER2 Overall Summary is a summary of results from HER2 testing.

Rationale

This data item is required for prognostic stage grouping in AJCC 8

edition, Chapter 48 Breast. It was

previously collected as Breast, CS SSF # 15. Experts recommend that every invasive breast cancer be

tested for the presence of HER2 because anti-HER2 treatments are highly effective for these tumors.

HER2 overall summary will be collected for Esophagus and Esophagogastric Junction and Stomach for

cases diagnosed 1/1/21+ because NCCN guidelines recommend HER2 testing at time of diagnosis if

patients are documented or suspected of having metastatic disease. HER2 monoclonal antibodies may

be added to chemotherapy for patients with HER2 positive disease.

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of HER2 Overall Summary can be used to code this data item when no

other information is available.

Note 3: HER2 may be recorded for all histologies; however, it is primarily performed for

adenocarcinomas. If information is not available, code 9.

Note 4: The result of the HER2 test performed on the primary tissue is to be recorded in this data item.

Use the highest (positive versus negative) when there are multiple results

Note 5: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no HER2 results from pre-treatment specimens,

report the findings from post-treatment specimens

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Code Description

0 HER2 negative; equivocal

1 HER2 positive

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Cannot be determined (indeterminate)

HER2 Overall Summary status not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is prior to 2021

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00169: Esophagus (including GE junction) (excluding Squamous) (2018+)

See 00161: Esophagus (including GE junction) Squamous (2018+)

3926: Schema Discriminator 1: EsophagusGEJunction (EGJ)/Stomach

3927: Schema Discriminator 2: Histology Discriminator for 8020/3

3855: HER2 Overall Summary

00170: Stomach (2018+)

See 00161: Esophagus (including GE junction) Squamous (2018+)

3926: Schema Discriminator 1: EsophagusGEJunction (EGJ)/Stomach

3855: HER2 Overall Summary

00190: Appendix (2018-2022)

See 00200: Colon and Rectum (2018+) for

3819: CEA Pretreatment Interpretation

3820: CEA Pretreatment Lab Value

09190: Appendix (2023+)

See 00200: Colon and Rectum (2018+) for

3819: CEA Pretreatment Interpretation

3820: CEA Pretreatment Lab Value

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09190: Appendix (2023+)

3960: Histologic Subtype

Item Length: 1

NAACCR Item #: 3960

XML Parent-NAACCR ID: histologicSubtype

NAACCR Alternate Name: None

Active years: 2023+

Schema(s):

09190: Appendix (2023+)

Definition

Histology code for appendiceal tumors (8480) is defined as “Mucinous Adenocarcinoma (in situ or

invasive).” In addition there are also low-grade appendiceal mucinous neoplasm (LAMN) and high-grade

appendiceal mucinous neoplasm (HAMN) diagnoses that are assigned the same histology.

Due to the different natures of these histologies, there is interest in tracking these different types of

tumors. With the current histology codes, a distinction cannot be made. A histology subtype data item is

needed.

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2023+.

a. For cases diagnosed 2018-2022, leave this SSDI blank

Note 2: Use the Solid Tumor Rules to determine histology prior to coding this SSDI.

Note 3: Histology 8480/2 or 8480/3 have multiple definitions that are collected in this histology. This

data item is used to further identify specific subtypes for histology code 8480/2 or 8480/3.

Examples:

1. Appendix: Disseminated peritoneal adenomucinous/low grade mucinous carcinoma peritonei.

Final diagnosis: Low grade appendiceal mucinous neoplasm

a. Code 1: This is a low grade mucinous (appendiceal) carcinoma (8480/3), which is LAMN.

The peritoneal adenomucinous/low grade mucinous carcinoma peritonei is describing

metastatic disease and not the histology

2. Appendix: Low grade (well diff) appendiceal adenocarcinoma

a. Code 0: This is an adenocarcinoma (8140/3), the low grade (well diff) is describing the

grade and not the histology

3. Appendix, appendectomy: Low grade appendiceal mucinous neoplasm (LAMN) with focal high

grade mucinous neoplasm.

a. Code 1: Based on the Solid Tumor Rules, the “focal” would be ignored and this would be

a LAMN.

4. Appendectomy: Mucinous adenocarcinoma of the appendix

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a. Code 3: Mucinous adenocarcinoma is the preferred terminology for histology code

8480/3. Since there is no mention of “low grade” or “high grade”, this would not be

LAMN or HAMN

5. Appendix: Mucinous (colloid) adenocarcinoma

a. Code 3: Colloid adenocarcinoma is an alternate name for 8480/3

Code

Description

0 Histology is NOT 8480

Low-grade appendiceal mucinous neoplasm

LAMN

High-grade appendiceal mucinous neoplasm

HAMN

Mucinous Adenocarcinoma/carcinoma

Mucus Adenocarcinoma/carcinoma

Mucoid adenocarcinoma/carcinoma

Colloid adenocarcinoma/carcinoma

4 Other terminology coded to 8480

BLANK

NA-Diagnosis year is prior to 2023

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00200: Colon and Rectum (2018+)

3819, 3820: CEA Pretreatment Lab Value and Interpretation

Definition

A protein molecule found in many different cells of the body but associated with certain tumors and

with the developing fetus. CEA is used as a tumor marker especially for gastrointestinal cancers, as

colorectal cancer is the most frequent cause for an increased/elevated CEA. CEA is also elevated by

biliary obstruction, alcoholic hepatitis, and heavy smoking. CEA level is most frequently tested on blood

serum, but it may be tested in body fluids and/or biopsy tissue. An abnormally high CEA level prior to

tumor resection is expected to fall following successful removal of the cancer. An increasing value

indicates possible recurrence.

There are 2 data items that record information on CEA. These data items should be coded from the

same test

3819: CEA Pretreatment Interpretation

3820: CEA Pretreatment Lab Value

Coding Guidelines

Record the highest value prior to treatment in nanograms per milliliter (ng/ml) in the range 0.1 (1 ng/ml)

to 9999.9 (9999 ng/ml) in the Lab Value data item and the clinician’s interpretation of the highest value

prior to treatment, based on the reference range used by the lab in the Interpretation data item.

Examples Lab Value Code Interpretation Code

0 ng/ml 0.0 0

23.6 ng/ml 23.6 1

127.8 ng/ml 127.8 1

3567 ng/ml 3567.0 1

11,000 XXXX.1 1

Test ordered, results not in chart XXXX.7 7

Not documented in medical record

CEA test not done

Unknown if CEA test done

XXXX.9

Additional Information

Other names: Carcinoembryonic antigen

Source documents: clinical laboratory report, sometimes pathology or cytology report; H&P,

operative report; consultant report; discharge summary

Normal reference range:

o Nonsmoker: < 2.5 ng/ml (SI: < 2.5 mg/L) SI Conversion: 1 mg/L = 1 ng/ml.

o Smoker: < 5 ng/ml (SI: < 5 mg/L) SI Conversion: 1 mg/mL = 1 ng/L

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00200: Colon and Rectum (2018+)

3820: CEA Pretreatment Lab Value

Item Length: 6

NAACCR Item #: 3820

XML Parent-NAACCR ID: Tumor-ceaPretreatmentLabValue

NAACCR Alternate Name: CEA (Carcinoembryonic Antigen) Pretreatment Lab Value

Active years: 2018+

Schema(s):

00190: Appendix (2018-2022)

09190: Appendix (2023+)

00200: Colon and Rectum (2018+)

Description

CEA (Carcinoembryonic Antigen) Pretreatment Lab Value records the CEA value prior to treatment. CEA

is a nonspecific tumor marker that has prognostic significance for colon and rectum cancer.

Rationale

CEA (Carcinoembryonic Antigen) Pretreatment Lab Value is a Registry Data Collection Variable in AJCC.

It was previously collected as Colon and Rectum, CS SSF #3.

See 3819, 3820: CEA Pretreatment Lab Value and Interpretation for additional information.

Coding Instructions and Codes

Note 1: Physician statement of CEA (Carcinoembryonic Antigen) Pretreatment Lab Value can be used to

code this data item when no other information is available.

Note 2: Record the lab value of the highest CEA test result documented in the medical record prior to

treatment or polypectomy. The lab value may be recorded in a lab report, history and physical, or

clinical statement in the pathology report.

Note 3: CEA is a tumor marker that has value in the management of certain malignancies.

Note 4: Record to the nearest tenth in nanograms/milliliter (ng/ml) the highest CEA lab value

documented in the medical record prior to treatment or polypectomy.

Example: Code a pretreatment CEA of 7 ng/ml as 7.0.

Note 5: Record 0.1 when the lab results are stated as less than 0.1 ng/ml with no exact value.

Note 6: The same laboratory test should be used to record information in 3819: CEA Pretreatment

Interpretation.

Code Description

0.0 0.0 nanograms/milliliter (ng/ml) exactly

0.1-

9999.9

0.1-9999.9 ng/ml

(Exact value to nearest tenth in ng/ml)

XXXX.1 10,000 ng/ml or greater

XXXX.7 Test ordered, results not in chart

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Code Description

XXXX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XXXX.8 may result in an edit error.)

XXXX.9 Not documented in medical record

CEA (Carcinoembryonic Antigen) Pretreatment Lab Value not assessed or unknown if assessed

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00200: Colon and Rectum (2018+)

3819: CEA Pretreatment Interpretation

Item Length: 1

NAACCR Item #: 3819

XML Parent-NAACCR ID: Tumor-ceaPretreatmentInterpretation

NAACCR Alternate Name: CEA (Carcinoembryonic Antigen) Pretreatment Interpretation

Active years: 2018+

Schema(s):

00190: Appendix (2018-2022)

09190: Appendix (2023+)

00200: Colon and Rectum (2018+)

Description

CEA (Carcinoembryonic Antigen) Pretreatment Interpretation refers to the interpretation of the CEA

value prior to treatment. CEA is a glycoprotein that is produced by adenocarcinomas from all sites as

well as many squamous cell carcinomas of the lung and other sites. CEA may be measured in blood,

plasma or serum. CEA is a prognostic marker for adenocarcinomas of the appendix, colon and rectum

and is used to monitor response to treatment.

Rationale

CEA (Carcinoembryonic Antigen) is a Registry Data Collection Variable for AJCC 8. CEA

(Carcinoembryonic Antigen) Pretreatment Interpretation was previously collected as Colon and Rectum,

CS SSF #1.

See 3819, 3820: CEA Pretreatment Lab Value and Interpretation for additional information.

Coding Instructions and Codes

Note 1: Physician statement of CEA (Carcinoembryonic Antigen) Pretreatment Interpretation

can be used to code this data item when no other information is available.

Note 2: Record the interpretation of the highest CEA test result documented in the medical record prior

to treatment or a polypectomy.

Note 3: Code 3 when a CEA value was documented in the record, but there is no statement that the CEA

is positive/elevated, negative/normal, and the normal range (from which you can determine

interpretation), is not documented.

Note 4: The same laboratory test should be used to record information in 3820: CEA Pretreatment Lab

Value.

Code Description

0 CEA negative/normal; within normal limits

1 CEA positive/elevated

2 Borderline

Undetermined if positive or negative (normal values not available)

AND no MD interpretation

Test

ordered, results not in chart

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Code Description

8 Not applicable: Information not collected for this case

(If this data item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

CEA (Carcinoembryonic Antigen) Pretreatment Interpretation not assessed or unknown if

assessed

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00200: Colon and Rectum (2018+)

3823: Circumferential Resection Margin (CRM)

Item Length: 4

NAACCR Item #: 3823

XML Parent-NAACCR ID: Tumor-circumferentialResectionMargin

NAACCR Alternate Name: Circumferential or Radial Resection Margin (CRM)

Active years: 2018+

Schema(s):

00200: Colon and Rectum (2018+)

Description

Circumferential or Radial Resection Margin, the distance in millimeters between the leading edge of the

tumor and the surgically dissected margin as recorded on the pathology report, is a prognostic indicator

for colon and rectal cancer. This may also be referred to as the Radial Resection Margin or surgical

clearance.

Rationale

Circumferential or Radial Resection Margin is a Registry Data Collection Variable in AJCC. It was

previously collected as Colon and Rectum CS SSF #6.

Definition

The CRM, also referred to as the radial margin or the mesenteric resection margin, is the measurement

of the distance from the deepest invasion of the tumor to the margin of resection in the

retroperitoneum or mesentery. In other words, the CRM is the width of the surgical margin at the

deepest part of the tumor in an area of the large intestine or rectum without serosa (non-peritonealized

rectum below the peritoneal reflection) or only partly covered by serosa (upper rectum, posterior

aspects of ascending and descending colon).

For segments of the colon completely encased by peritoneum, the mesenteric resection margin is the

only relevant circumferential margin.

The CRM is not the same as the distance to the proximal and distal margins of the colon specimen. For

rectal cancers, the circumferential resection margin is the most important predictor of local-regional

recurrence.

Coding guidelines

Code 0.0 is for positive margins, or margin is less than 0.1 mm

Codes 0.1-99.9 is for coding the exact measurement in millimeters of the negative margin

Code XX.0 for margins described as greater than 100 mm

Code XX.1 when the margin is stated as clear, but the distance is not available

Code XX.2 when the margins cannot be assessed

Note: ONLY when the pathology reports/CAP checklist states that the margin cannot be

assessed/evaluated.

Codes XX.3-XX.6 is for when the pathology uses “at least” categories

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Code XX.7 when there is no surgical resection of the primary site

Code XX.9 when

Not documented in the medical record

CRM is not evaluated (assessed)

Checked “Not applicable: Radial or Mesenteric Margin” on CAP Checklist

Unknown if CRM is evaluated (assessed)

Additional Information

Source documents: pathology report

For further information, refer to the Colon and Rectum cancer protocol published by the College

of American Pathologists for the AJCC Staging System Colon and Rectum

Coding Instructions and Codes

Note 1: Physician statement of Circumferential or Radial Resection Margin can be used to code this data

item when no other information is available.

Note 2: Per the AJCC Staging System Colon and Rectum, “the CRM is the distance in millimeters between

the deepest point of tumor invasion in the primary cancer and the margin of resection in the

retroperitoneum or mesentery.”

Note 3: The following guidelines were developed for the coding of surgery codes in relation to CRM.

These guidelines were confirmed by the CAP Cancer Committee.

For Colon primaries, surgery of primary site must be coded as 30-80

o If surgery of primary site is 00-29, then CRM must be coded as XX.7

For Rectal primaries, surgery of primary site must be coded as 27, 30-80

o If surgery of primary site is 00-26 or 28, then CRM must be coded as XX.7

Note 4: Tumor involvement of the circumferential resection margin or radial resection margin appears

to be a strong prognostic factor for local or systemic recurrences and survival after surgery

Note 5: The CRM may be referred to as

Circumferential radial margin

Circumferential resection margin

Mesenteric (mesocolon) (mesorectal) margin

Radial margin

Soft tissue margin

Note 6: Record in Millimeters (mm) to the nearest tenth the distance between the leading edge of the

tumor and the nearest edge of surgically dissected margin as recorded in the pathology report.

Examples

If the CRM is 2 mm, code 2.0

If the CRM is 2.78 mm, code 2.8

Note 7: If the value is recorded in Centimeters, multiply by 10 to get the value in Millimeters (mm).

Example: CRM recorded as 0.2 cm. Multiply 0.2 x 10 and record 2.0

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Note 8: If the margin is involved (positive), code 0.0. If the margin is described as less than 0.1 mm with

no more specific measurement, Code 0.0; margins of 0-1.0 mm are recorded by the pathologist as

involved.

Note 9: Code XX.2 (Margins cannot be assessed) ONLY when the pathology reports/CAP checklist states

that the margin cannot be assessed/evaluated.

Note 10: An exact measurement takes precedence over codes 0.0 and those beginning with XX.

Exact measurement takes priority even if the pathologist states the margin is positive.

Example: CRM stated as 0.3 mm in Final Diagnosis and Synoptic states: Circumferential (Radial)

Margin Interpreted as involved by invasive carcinoma (tumor less than 1mm from margin).

o Code the 0.3 mm instead of 0.0 (margin involved with tumor)

Note 11: Code XX.9 when

Checked “Not applicable: Radial or Mesenteric Margin” on CAP Checklist

Pathology report describes only distal and proximal margins, or margins, NOS

o Only specific statements about the CRM are collected in this data item

CRM not mentioned in the record

Code Description

0.0 Circumferential resection margin (CRM) positive

Margin IS involved with tumor

Described as "less than 0.1 millimeter (mm)"

0.1-

99.9

Distance of tumor from margin: 0.1- 99.9 millimeters (mm)

(Exact size to nearest tenth of millimeter)

XX.0 100 mm or greater

XX.1 Margins clear, distance from tumor not stated

Circumferential or radial resection margin negative, NOS

No residual tumor identified on specimen

XX.2 Margins cannot be assessed

XX.3 Described as “at least” 1 mm

XX.4 Described as “at least” 2 mm

XX.5 Described as “at least” 3 mm

XX.6 Described as "greater than” 3 mm

XX.7 No resection of primary site

Surgical procedure did not remove enough tissue to measure the circumferential or radial resection

margin

(Examples include: polypectomy only, endoscopic mucosal resection (EMR), excisional biopsy only,

transanal disk excision)

XX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XX.8 may result in an edit error.)

XX.9 Not documented in medical record

Non-invasive neoplasm (behavior /2)

Circumferential or radial resection margin not assessed or unknown if assessed

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00200: Colon and Rectum (2018+)

3866: KRAS

Item Length: 1

NAACCR Item #: 3866

XML Parent-NAACCR ID: Tumor-kras

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00200: Colon and Rectum (2018+)

Description

KRAS is an important signaling intermediate in the growth receptor pathway which controls cell

proliferation and survival. KRAS is a protein with production controlled by the K-ras gene. When the K-

ras gene is activated through mutation during colorectal carcinogenesis, production of KRAS

continuously stimulates cell proliferation and prevents cell deaths. Activating mutations in KRAS are an

adverse prognostic factor for colorectal carcinoma and predict a poor response to monoclonal anti-EGFR

antibody therapy in advanced colorectal carcinoma.

Rationale

KRAS is a Registry Data Collection Variable in AJCC. It was previously collected as Colon and Rectum CS

SSF #9.

Definition

KRAS is an oncogene (a gene that, when mutated or overexpressed, helps turn a normal cell into a

cancer cell). Mutations of KRAS indicate that a patient may not respond to the anti-epidermal growth

factor receptor drugs cetuximab (Erbitux) or panitumumab (Vectibix). ASCO recommends that Stage IV

colorectal patients be tested for KRAS if anti-EGFR therapy is being considered. There are two types of

KRAS genes: normal and mutated. The normal KRAS gene is also called the wild type allele; the mutated

gene may be described as abnormal or having an abnormal codon (abnormal DNA sequence).

Additional Information

Source documents: pathology report or clinical laboratory report

Other names: K-Ras, K-ras, Ki-Ras

For further information, refer to the Colon and Rectum Biomarker Reporting cancer protocol

published by the College of American Pathologists for the AJCC Staging System Colon and

Rectum

Coding Instructions and Codes

Note 1: Physician statement of KRAS can be used to code this data item when no other information is

available.

Note 2: KRAS is a gene which belongs to a class of genes known as oncogenes. When mutated,

oncogenes have the potential to cause normal cells to become cancerous. Studies suggest that KRAS

gene mutations are often present in colorectal cancer.

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Note 3: There are 4 KRAS codons that are commonly mutated in colorectal cancers. This SSDI does not

record the actual mutation, but instead records the codon or codon group that contains the mutation. If

a specific KRAS mutation is reported, its codon may be identified from the following list of common

KRAS mutations grouped by codon.

Codon 12

o Gly12Asp (GGT>GAT)

o Gly12Val (GGT>GTT)

o Gly12Cys (GGT>TGT)

o Gly12Ser (GGT>AGT)

o Gly12Ala (GGT>GCT)

o Gly12 Arg (GGT>CGT)

o Codon 12 mutation, not otherwise specified

Codon 13

o Gly13Asp (GGC>GAC)

o Gly13Arg (GGC>CGC)

o Gly13Cys (GGC>TGC)

o Gly13Ala (GGC>GCC)

o Gly13Val (GGC>GTC)

o Codon 13 mutation, not otherwise specified

Codon 61

o Gln61Leu (CAA>CTA)

o Gln61His (CAA>CAC)

o Codon 61 mutation, not otherwise specified

Codon 146

o Ala146Thr (G436A) (GCA>ACA)

o Codon 146 mutation, not otherwise specified

Note 4: KRAS analysis is commonly done for patients with metastatic disease.

Note 5: Results from nodal or metastatic tissue may be used for KRAS.

Note 6: Record the results of the KRAS from the initial workup (clinical and pathological workup).

Note 7: If KRAS is positive and there is no mention of the mutated codon, or the mutated codon is not

specified, code 4.

Note 8: Code 9 when

Insufficient amount of tissue available to perform test

No microscopic confirmation of tumor

KRAS not ordered or not done, or unknown if ordered or done

Code

Description

0 Normal

KRAS negative, KRAS wild type

Negative for (somatic) mutations, no alterations, no (somatic) mutations identified, not present,

not detected

1 Abnormal (mutated) in codon(s) 12, 13 and/or 61

2 Abnormal (mutated) in codon 146 only

Abnormal (mutated), but not in codon(s) 12, 13, 61, or 146

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Code Description

Abnormal (mutated), NOS, codon(s) not specified

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

KRAS not assessed or unknown if assessed

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00200: Colon and Rectum (2018+)

3890: Microsatellite Instability (MSI)

Item Length: 1

NAACCR Item #: 3890

XML Parent-NAACCR ID: Tumor-microsatelliteInstability

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00200: Colon and Rectum (2018+)

Description

Microsatellite Instability (MSI) is a form of genetic instability manifested by changes in the length of

repeated single- to six-nucleotide sequences (known as DNA microsatellite sequences). High MSI, found

in about 15% of colorectal carcinomas, is an adverse prognostic factor for colorectal carcinomas and

predicts poor response to 5-FU chemotherapy (although the addition of oxaliplatin in FOLFOX regimens

negates the adverse effects (page 266 AJCC manual)). High MSI is a hallmark of hereditary nonpolyposis

colorectal carcinoma, also known as Lynch syndrome.

Rationale

Microsatellite Instability (MSI) is a Registry Data Collection Variable in AJCC. It was previously collected

as Colon and Rectum, CS SSF #7.

Definition

Describes cancer cells that have a greater than normal number of genetic markers called microsatellites.

Microsatellites are short, repeated, sequences of DNA. Cancer cells that have large numbers of

microsatellites may have defects in the ability to correct mistakes that occur when DNA is copied in the

cell. Microsatellite instability is found most often in colorectal cancer, other types of gastrointestinal

cancer, and endometrial cancer. It may also be found in cancers of the breast, prostate, bladder, and

thyroid. Knowing whether cancer is microsatellite instability high may help plan the best treatment.

Additional Information

Other names: MSI-H

For further information, refer to the Colon and Rectum Biomarker Reporting cancer protocol

published by the College of American Pathologists for the AJCC Staging System Colon and

Rectum

Coding Instructions and Codes

Note 1: Physician statement of MSI can be used to code this data item when no other information is

available.

Note 2: The microsatellite instability (MSI) test is a genetic test performed on tumor tissue to look for

differences in length of certain non-functioning sections of DNA. The differences are caused by problems

with the genes that encode proteins that normally repair certain types of DNA damage. A high proportion

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of colon cancers arising in patients with hereditary nonpolyposis colorectal cancer (HNPCC) (also known

as Lynch syndrome) have high MSI and a smaller percentage of colon cancers not associated with Lynch

syndrome have high MSI. Patients with colon cancers with high MSI may be further tested to determine

if they have HNPCC. In addition, MSI is a useful prognostic marker in that patients with high MSI colon

cancers have better response to surgery and survival.

Note 3: MSI may be recorded for all stages; however, it is primarily performed for invasive neoplasms.

For non-invasive neoplasms (behavior /2), code to 9 if no information available.

Note 4: Results from nodal or metastatic tissue may be used for Microsatellite instability.

Note 5: Testing for MSI may be done by immunology or genetic testing. Only genetic testing results will

specify whether the MSI is low or high.

MSI is looking at instability in informative markers

MSI results are recorded as

o MSS (Code 0)

o Stable (Code 0)

o Negative (Code 0)

o Low probability of MSI-H (Code 0)

o MSS/MSI-L (Code 0)

o MSI-L (Code 1)

o Unstable, high (Code 2)

o Unstable, NOS (no designation of high or low) (Code 2)

o MSI-H (Code 2)

o MSI-I (intermediate) (Code 9)

Note 6: Testing for Mismatch Repair (MMR) is usually done by immunohistochemistry (IHC).

Most common markers are MLH1, MSH2, MSH6, PMS2

MMR results are recorded as

o No loss of nuclear expression (code 0)

o Mismatch repair (MMR) intact (code 0)

o MMR proficient (pMMR or MMR-P) (code 0)

o MMR normal (code 0)

o Loss of nuclear expression (code 2)

o MMR deficient (dMMR or MMR-D) (code 2)

o MMR abnormal (code 2)

Note 7: If both tests are done and one or both are positive, code 2.

Note 8: If all tests done are negative, code 0.

Code Description

0 Microsatellite instability (MSI) stable; microsatellite stable (MSS); negative, NOS

AND/OR

Mismatch repair (MMR) intact, no loss of nuclear expression of MMR proteins

MMR proficient (pMMR or MMR-P)

1 MSI unstable low (MSI-L)

2 MSI unstable high (MSI-H)

AND/OR

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Code Description

MMR-D (dMMR or MMR-D), loss of nuclear expression of one or more MMR proteins, MMR

protein deficient)

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

MSI-indeterminate

MSI-equivocal

Microsatellite instability not assessed or unknown if assessed

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00200: Colon and Rectum (2018+)

3909: Perineural Invasion

Item Length: 1

NAACCR Item #: 3909

XML Parent-NAACCR ID: Tumor-perineuralInvasion

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00150: Cutaneous Carcinoma of the Head and Neck (2018+)

00200: Colon and Rectum (2018+)

00640: Skin Eyelid (2018+)

00690: Lacrimal Gland (2018+)

Description

Perineural Invasion, within or adjacent to the primary tumor, is a negative prognostic factor for

cutaneous squamous cell carcinomas of the head and neck and carcinomas of the colon and rectum,

eyelid and lacrimal gland.

Rationale

Perineural Invasion is a Registry Data Collection Variable in AJCC. It was previously collected as Colon

and Rectum CS SSF #8 and Lacrimal Gland CS SSF #4.

Definition

Perineural invasion is infiltration of nerves in the area of the lesion by tumor cells or spread of tumor

along the nerve pathway. The presence of perineural invasion has been shown in several studies to be

an indicator of poor patient prognosis. If perineural invasion is not mentioned in the pathology report,

do not assume that there is no perineural invasion.

Additional Information

Source documents: pathology report

Other names: PNI, neurotropism

For further information, refer to the Colon and Rectum cancer protocol published by the College

of American Pathologists for the AJCC Staging System Colon and Rectum

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of perineural invasion, the registrar could assume that it was negative and code

appropriately. Per the SSDI as of 2018, this assumption cannot be made. There must be a

statement that perineural invasion is not present/negative to assign “negative.” (Code 0)

Coding Instructions and Codes

Note 1: Physician statement of microscopically confirmed perineural invasion can be used to code this

data item when no other information is available.

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Note 2: Code the presence or absence of perineural invasion by the primary tumor as documented in

the pathology report.

Note 3: Information on presence of perineural invasion can be taken from either a biopsy or resection.

Absence of perineural invasion can only be taken from a surgical resection pathology report.

Note 4: Code 9 if surgical resection of the primary site is performed and there is no mention of

perineural invasion.

Code Description

Perineural invasion not identified/not present

Non-invasive neoplasm (behavior /2)

1 Perineural invasion identified/present

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

Pathology report does not mention perineural invasion

Cannot be determined by the pathologist

Perineural invasion not assessed or unknown if assessed

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00200: Colon and Rectum (2018+)

3934: Tumor Deposits

Item Length: 2

NAACCR Item #: 3934

XML Parent-NAACCR ID: Tumor-tumorDeposits

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00200: Colon and Rectum (2018+)

Description

A tumor deposit is defined as a discrete nodule of cancer in pericolic/perirectal fat or in adjacent

mesentery (mesocolic or rectal fat) within the lymph drainage area of the primary carcinoma, without

identifiable lymph node tissue or identifiable vascular structure.

Rationale

The presence of tumor deposits is a Registry Data Collection Variable in AJCC. It was previously

collected as Colon and Rectum CS SSF #4.

Definition

Tumor deposits are separate nodules or deposits of malignant cells in perirectal or pericolic fat without

evidence of residual lymph node tissue. If present, tumor deposits may be found within the primary

lymphatic drainage area of the tumor. They are different from direct extension from the primary tumor

and may be the result of lymphovascular invasion with extravascular extension, a totally replaced lymph

node, or discontinuous spread. Nodules of tumor outside the primary lymphatic drainage area of the

tumor are distant metastasis.

Coding guidelines

Record whether tumor deposits are present or absent.

Code 00 when the pathology report states that there are no tumor deposits

Code the number of tumor deposits reported in the pathology report. Do not count involved lymph

nodes in this field, only tumor deposits

Code X1 for 100 or more tumor deposits

Code X2 if tumor deposits are mentioned but a number is not reported

Code X9 when

o Not documented in medical record

o No surgical resection done

o Pathology report not available

o Tumor deposits not evaluated (not assessed)

o Unknown if Tumor Deposits evaluated (assessed)

Additional Information

Source documents: pathology report

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Other names: discontinuous extramural extension, malignant tumor foci, malignant peritumoral

deposits, satellite nodule

For further information, refer to the Colon and Rectum cancer protocol published by the College

of American Pathologists for the AJCC Staging System Colon and Rectum

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of tumor deposits, the registrar could assume there were no tumor deposits and

code none. For the SSDI, this assumption cannot be made. There must be a statement that there

are no tumor deposits to code 00.

Coding Instructions and Codes

Note 1: Physician statement of Tumor Deposits can be used to code this data item when no other

information is available.

Note 2: Tumor deposits are defined as one or more satellite peritumoral nodules in the pericolorectal

adipose tissue of a primary carcinoma without histologic evidence of residual lymph node in the

nodule.”

Tumor deposits may represent discontinuous spread, venous invasion with extravascular

spread, or a totally replaced lymph node

Note 3: Record the number of Tumor Deposits whether or not there are positive lymph nodes.

Note 4: Code X9 if surgical resection of the primary site is performed, the pathology report is available,

and tumor deposits are not mentioned.

Code Description

00 No tumor deposits

01-

01-99 Tumor deposits

(Exact number of Tumor Deposits)

X1 100 or more Tumor Deposits

X2 Tumor Deposits identified, number unknown

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit error.)

X9 Not documented in medical record

Cannot be determined by the pathologist

Pathology report does not mention tumor deposits

No surgical resection done

Tumor Deposits not assessed or unknown if assessed

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00200: Colon and Rectum (2018+)

3940: BRAF Mutational Analysis

Item Length: 1

NAACCR Item #: 3940

XML Parent-NAACCR ID: Tumor-brafMutationalAnalysis

Active years: 2021+

Schema(s):

00200: Colon and Rectum (2018+)

Description

The BRAF oncoprotein is involved in transmitting cell growth and proliferation signals from KRAS and

NRAS. The BRAF V600E mutation is associated with poorer prognosis and predicts lack of response to

anti-EGFR therapies.

Rationale

BRAF mutational analysis is recommended in clinical guidelines for patients with advanced colorectal

cancer as a prognostic marker and factor in determining appropriate therapy. It is a new data item for

cases diagnosed 1/1/2021+.

Definition

“BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in

sending signals in cells and in cell growth. This BRAF gene mutation is found in colorectal cancer. It may

increase the growth and spread of cancer cells. Checking for this BRAF mutation in tumor tissue may

help to plan cancer treatment. BRAF (V600E) kinase inhibitor RO5185426 blocks certain proteins made

by the mutated BRAF gene, which may help keep cancer cells from growing.” (NCI Dictionary of Cancer

Terms https://www.cancer.gov/publications/dictionaries/cancer-terms)

Additional Information

Source documents: pathology report or clinical laboratory report

For further information, refer to the Colon and Rectum Biomarker Reporting cancer protocol

published by the College of American Pathologists for the AJCC Staging System Colon and

Rectum

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of BRAF can be used to code this data item when no other information is

available.

Note 3: BRAF may be recorded for all stages; however, it is primarily performed for patients with

metastatic disease. If information is not available, code 9.

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Note 4: BRAF is a gene which belongs to a class of genes known as oncogenes. When mutated,

oncogenes have the potential to cause normal cells to become cancerous. Studies suggest that BRAF

gene mutations are often present in colorectal cancer. The most common BRAF mutations is

BRAF V600E (c.1799T>A) mutation

Note 5: The most common testing methods for BRAF are

Direct Sanger sequencing

High-resolution melting analysis

Pyrosequencing

PCR, allele-specific hybridization

Real-time PCR

Note 6: Results from nodal or metastatic tissue may be used for BRAF.

Note 7: If BRAF is positive and there is no mention of the mutated codon, or the mutated codon is not

specified, code 4.

Note 8: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no BRAF results from pre-treatment specimens,

report the findings from post-treatment specimens

Note 9: Code 9 when

Insufficient amount of tissue available to perform test

No microscopic confirmation of tumor

BRAF not ordered or not done, or unknown if ordered or done

Code

Description

0 Normal

BRAF negative, BRAF wild type

Negative for (somatic) mutations, no alterations, no (somatic) mutations identified, not present,

not detected

1 Abnormal (mutated)/detected: BRAF V600E (c.1799T>A) mutation

2 Abnormal (mutated)/detected, but not BRAF V600E (c.1799T>A) mutation

Abnormal (mutated), NOS

st ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

Not documented in medical record

BRAF not assessed or unknown if assessed

<Blank>

N/A

Diagnosis year is prior to 2021

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00200: Colon and Rectum (2018+)

3941: NRAS Mutational Analysis

Item Length: 1

NAACCR Item #: 3941

XML Parent-NAACCR ID: Tumor-nrasMutationalAnalysis

NAACCR Alternate Name: None

Active years: 2021+

Schema(s):

00200: Colon and Rectum (2018+)

Description

NRAS is a signaling intermediate in the growth receptor pathway. Certain NRAS mutations predict poor

response to anti-EGFR therapy in patients with metastatic colorectal cancer.

Rationale

NRAS mutational analysis is recommended in clinical guidelines for patients with metastatic colon

cancer who are being considered for anti-EGFR therapy. It is a new data item for cases diagnosed

1/1/2021+.

Definition

KRAS (NAACCR Data Item # 3866) and NRAS are important signaling intermediates in the growth

receptor pathway, which controls cell proliferation and survival. Both KRAS and NRAS may be

constitutively activated through mutation during colorectal carcinogenesis so that they continuously

stimulate cell proliferation and prevent cell death (reference AJCC 8, pg. 266). KRAS and NRAS

mutations predict poor response to anti-EGFR therapy in patients with metastatic colon cancer. AJCC 8

estimates that KRAS may be activated in up to 40% and NRAS in about 7% of colorectal carcinomas.

Additional Information

Source documents: pathology report or clinical laboratory report

For further information, refer to the Colon and Rectum Biomarker Reporting cancer protocol

published by the College of American Pathologists for the AJCC Staging System Colon and

Rectum

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of NRAS can be used to code this data item when no other information is

available.

Note 3: NRAS may be recorded for all stages; however, it is primarily performed for patients with

metastatic disease. If information is not available, code 9.

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Note 4: NRAS is a gene which belongs to a class of genes known as oncogenes. When mutated,

oncogenes have the potential to cause normal cells to become cancerous. Studies suggest that NRAS

gene mutations are often present in colorectal cancer.

Note 5: There are 3 NRAS codons that are commonly mutated in colorectal cancers. This SSDI does not

record the actual mutation, but instead records the codon or codon group that contains the mutation. If

a specific NRAS mutation is reported, its codon may be identified from the following list of common

NRAS mutations grouped by codon.

Codon 12

o Gly12Asp (GGT>GAT)

o Gly12Val (GGT>GTT)

o Gly12Cys (GGT>TGT)

o Gly12Ser (GGT>AGT)

o Gly12Ala (GGT>GCT)

o Gly12Arg (GGT>CGT)

o Codon 12 mutation, not otherwise specified

Codon 13

o Codon 13 mutation, not otherwise specified

Codon 61

o Gln61Lys (CAA>AAA)

o Gln61Arg (CAA>CGA)

o Codon 61 mutation, not otherwise specified

Note 6: Results from nodal or metastatic tissue may be used for NRAS.

Note 7: If NRAS is positive and there is no mention of the mutated codon, or the mutated codon is not

specified, code 4.

Note 8: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no NRAS results from pre-treatment specimens,

report the findings from post-treatment specimens

Note 9: Code 9 when

Insufficient amount of tissue available to perform test

No microscopic confirmation of tumor

NRAS not ordered or not done, or unknown if ordered or done

Code Description

0 Normal

NRAS negative; NRAS wild type

Negative for (somatic) mutations, no alterations, no (somatic) mutations identified, not present,

not detected

1 Abnormal (mutated)/detected in codon(s) 12, 13, and/or 61

2 Abnormal (mutated)/detected, codon(s) specified but not in codon(s) 12, 13, or 61

4 Abnormal (mutated), NOS, codon(s) not specified

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

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Code Description

9 Not documented in medical record

NRAS not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is prior to 2021

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09210: Anus (2023+)

3956: p16

Item Length: 1

NAACCR Item #: 3956

XML Parent-NAACCR ID: Tumor-p16

NAACCR Alternate Name: None

Active years: 2022+

Schema(s):

09520: Cervix (2021+)

09210: Anus (2023+)

Description

The p16 biomarker is overexpressed (produced) in response to HPV. It is therefore a surrogate marker

for HPV disease.

Rationale

Patients with HPV have a different survival or outcome so it is important to be able to distinguish this by

documenting the p16 results. Testing is performed by immunohistochemistry (IHC) which is inexpensive

and has near universal availability. It has an easily standardized interpretation. HPV testing is usually

performed through DNA testing which is more expensive and less widely available. HPV testing also has

technically more variability with the interpretation.

Definition

p16 is a tumor suppressor protein also known as cyclin-dependent kinase inhibitor 2A. The p16

biomarker is overexpressed (produced) in response to HPV. It is therefore a surrogate marker for HPV

disease.

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2023+.

For cases diagnosed 2018-2022, leave this SSDI blank

Note 2: Code 0 for p16 expression of weak intensity or limited distribution.

Note 3: This data item must be based on testing results for p16 overexpression.

A statement of a patient being HPV positive or negative is not enough to code this data item

Testing for HPV by DNA, mRNA, antibody, or other methods should not be coded in this data

item

Do not confuse p16 with HPV 16, which is a specific strain of virus

Code Description

0 p16 Negative; Nonreactive

1 p16 Positive; Diffuse, Strong reactivity

Not

applicable: Information not collected for this case

(If this time is required by your standard setter, use of code 8 will result in an edit error)

9 Not tested for p16; Unknown

<Blank> N/A-Diagnosis year prior to 2023

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HEPATOBILIARY SYSTEM

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00220: Liver (2018+)

3809, 3810: Alpha-Fetoprotein (AFP) Pretreatment Lab Value and Interpretation (Liver)

Definition

A protein normally produced by a fetus. Alpha fetoprotein levels are usually undetectable in the blood

of healthy adult men or women (who are not pregnant). An elevated level of alpha-fetoprotein suggests

the presence of either a primary liver cancer or germ cell tumor.

For Liver, there are 2 data items that record information on AFP. These data items should be coded

from the same test

3809: AFP Pretreatment Interpretation

3810: AFP Pretreatment Lab Value

Additional information

o Source documents: clinical laboratory report (blood serum radioimmunoassay or enzyme assay

(EIA)); sometimes in history and physical or clinical statement in pathology report

o Normal Reference Range: Adult men and non-pregnant women: 0-15 ng/ml (SI: 0-15 mg/L)

Coding guidelines

Record the highest value prior to treatment in nanograms per milliliter (ng/ml) in the range 0.1 (1 ng/ml)

to 9999.9 (9999 ng/ml) in the Lab Value data item and the clinician’s interpretation of the highest value

prior to treatment, based on the reference range used by the lab in the Interpretation data item.

Examples for AFP Pretreatment Lab Value and Interpretation

Examples Lab Value

Code

Interpretation

Code

0 ng/ml 0.0 1

23.6 ng/ml 23.6 2

127.8 ng/ml 127.8 2

3567 ng/ml 3567.0 2

11,000 XXXX.1 2

AFP test not done, or unknown if done XXXX.9 9

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00220: Liver (2018+)

3810: AFP Pretreatment Lab Value

Item Length: 6

NAACCR Item #: 3810

XML Parent-NAACCR ID: Tumor-afpPretreatmentLabValue

NAACCR Alternate Name: AFP (Alpha Fetoprotein) Pretreatment Lab Value

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

AFP (Alpha Fetoprotein) Pretreatment Lab Value is a nonspecific serum protein that generally is elevated

in the setting of hepatocellular carcinoma (HCC). This data item pertains to the pre-treatment lab value.

Rationale

AFP (Alpha Fetoprotein) Pretreatment Lab Value is a Registry Data Collection Variable in AJCC. This data

item was previously collected for Liver, CS SSF #3.

See 3809, 3810: Alpha-Fetoprotein (AFP) Pretreatment Lab Value and Interpretation (Liver) for

additional information

Coding Instructions and Codes

Note 1: Physician statement of AFP (Alpha Fetoprotein) Pretreatment Lab Value can be used to code this

data item when no other information is available.

Note 2: Record the lab value of the highest AFP test result documented in the medical record prior to

treatment. The lab value may be recorded in a lab report, history and physical, or clinical statement in

the pathology report.

Note 3: A lab value expressed in micrograms per liter (ug/L) is equivalent to the same value expressed in

ng/ml.

Note 4: The same laboratory test should be used to record information in 3809: AFP Pretreatment

Interpretation.

Code Description

0.0 0.0 nanograms/milliliter (ng/ml); not detected

0.1-

9999.9

0.1-9999.9 ng/ml

(Exact value to nearest tenth of ng/ml)

XXXX.1 10,000.0 ng/ml or greater

XXXX.7 Test ordered, results not in chart

XXXX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XXXX.8 will result in an edit error.)

XXXX.9 Not documented in medical record

AFP (Alpha Fetoprotein) Pretreatment Lab Value not assessed or unknown if assessed

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00220: Liver (2018+)

3809: AFP Pretreatment Interpretation

Item Length: 1

NAACCR Item #: 3809

XML Parent-NAACCR ID: Tumor-afpPretreatmentInterpretation

NAACCR Alternate Name: AFP (Alpha Fetoprotein) Pretreatment Interpretation

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

AFP (Alpha Fetoprotein) Pretreatment Interpretation, a nonspecific serum protein that generally is

elevated in the setting of hepatocellular carcinoma (HCC), is a prognostic factor for liver cancer.

Rationale

AFP (Alpha Fetoprotein) Pretreatment Interpretation is a Registry Data Collection Variable in AJCC. This

data item was previously collected for Liver, CS SSF #1.

See 3809, 3810: Alpha-Fetoprotein (AFP) Pretreatment Lab Value and Interpretation (Liver) for

additional information

Coding Instructions and Codes

Note 1: Physician statement of AFP (Alpha Fetoprotein) Pretreatment Interpretation can be used to

code this data item when no other information is available.

Note 2: Record the interpretation of the highest AFP test result documented in the medical record prior

to treatment.

Note 3: The same laboratory test should be used to record information in 3810: AFP Pretreatment Lab

Value.

Code Description

0 Negative/normal; within normal limits

1 Positive/elevated

2 Borderline; undetermined if positive or negative

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

AFP pretreatment interpretation not assessed or unknown if assessed

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00220: Liver (2018+)

3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score

The Model for End-stage Liver Disease (MELD) score is used to assess the severity of chronic liver

disease, and its original purpose was to help prioritize patients for liver transplant by estimating their

risk of dying while waiting for transplant. There are several data items that are defined to record the

MELD score.

3813: Bilirubin Pretreatment Total Lab Value

3814: Bilirubin Pretreatment Unit of Measure

3824: Creatinine Pretreatment Lab Value

3825: Creatinine Pretreatment Unit of Measure

3860: International Normalized Ratio

Bilirubin Pretreatment Lab Value and Unit of Measure

Bilirubin is produced from the breakdown of hemoglobin (the protein that binds oxygen) in red blood

cells. The liver processes bilirubin by excreting it through bile into the intestine. If the liver is damaged,

there will be too much bilirubin in the blood, and this can produce jaundice. Elevated bilirubin levels can

indicate liver or blood disorders or blockage of bile ducts. Do not code individual conjugate, direct,

unconjugated, indirect, or delta values or bilirubin in urine.

There are two methods of describing bilirubin levels in the blood, weight in grams (milligrams per

deciliter), usually used in the US, and molecular count in moles (micromoles per liter) in Canada.

Conversion: 1 mg/dL = 17.1 mol/L. Code the unit of measure used by the facility laboratory.

Coding guidelines

Record the highest value prior to treatment in the range 0.1 (1 ng/ml) to 999.9 in the Lab Value data

item and the unit of measure for measuring the lab value in the Unit of Measure data item.

Examples Lab Value

Code

Unit of Measure

Code

0 ng/ml 0.0 1

23.6 umol/L 23.6 2

127.8 ng/mL 127.8 1

1567 umol/mL XXX.1 2

638.4 638.4 9

Test ordered, results not in chart XXXX.7 7

Not documented in medical record

Bilirubin test not done

Unknown if Bilirubin test done

XXXX.9 9

Additional Information

o Source documents: clinical laboratory report (blood serum); value may be part of a metabolic or

liver function panel

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o Other names: TBIL. Total bilirubin is a combination of direct (conjugated), indirect

(unconjugated), and delta (conjugated bilirubin bound to albumin) bilirubin levels

o Normal Reference Range: 0.3-1.5 mg/dL (5-20.5 mol/L). The normal range may vary slightly

from lab to lab.

o For Liver, there are 2 data items that record information on Bilirubin. These data items

should be coded from the same test

o Bilirubin Pretreatment Total Lab Value [NAACCR Data Item #3813]

o Bilirubin Pretreatment Unit of Measure [NAACCR Data item #3814]

Creatinine Pretreatment Lab Value and Unit of Measure

Creatinine concentration in blood is a marker of renal function. Elevated levels are associated with

severe liver disease. Creatinine can be measured in blood serum or urine, but these data items apply to

blood levels only. Do not code urine creatinine or creatinine clearance in this field.

There are two methods of describing creatinine levels in the blood, weight in grams (milligrams per

deciliter), usually used in the US, and molecular count in moles (micromoles per liter) in Canada.

Conversion: 1 mg/dL = 17.1 mol/L. Code the unit of measure used by the facility laboratory.

Coding guidelines

Record the highest value prior to treatment in the range 0.1 (1 ng/ml) to 999.9 in the Lab Value data

item and the unit of measure for measuring the lab value in the Unit of Measure data item.

Examples Lab Value Code Unit of Measure Code

0 ng/ml 0.0 1

0.7 umol/L 0.7 2

25.4 ng/ml 25.4 1

127.6 umol/L XX.1 2

98.3 98.3 9

Test ordered, results no in chart XXXX.7 7

Not documented in medical record

Creatinine test not done

Unknown if Creatinine test done

XXXX.9 9

Additional Information

Source documents: clinical laboratory report (blood serum); value may be part of a metabolic

panel

Other names: Serum creatinine, plasma creatinine (PCr), blood creatinine, Creat, Cre.

o Do not confuse with creatinine clearance or creatine; these are unrelated tests. Do not

code urine creatinine or creatinine clearance.

Normal Reference Range

o Women: 0.5-1.0 mg/dL (45-90 mmol/L)

o Men: 0.7-1.2 mg/dL (60-110 mmol/L). Male values are usually higher due to greater

muscle mass.

o Normal value ranges may vary slightly among different laboratories.

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International Normalized Ratio (Prothrombin Time)

The prothrombin time is a measure of how quickly the blood clots, which may also indicate liver disease.

The international normalized ratio (INR) is a calculation of the patient’s prothrombin time divided by the

normal mean prothrombin time for the particular thromboplastin reagent used and is expressed as a

decimal number. An elevated level indicates the blood is too “thin” and does not clot properly,

increasing the risk of bleeding. A value under 1.0 increases the risk of blood clots.

Coding guidelines

Code the highest INR value in the blood prior to treatment in the range 0.1 to 9.9.

Code X.1 for an INR of 10.0 or greater.

Code X.7 if the test was ordered and the results are not in the medical record.

Code X.9 when

o there is no information in the medical record about the INR or prothrombin time

o the test is not done or it’s unknown if the test was done

Additional Information

Source documents: clinical laboratory report (blood serum); value may be part of a metabolic or

liver function panel; outpatient or ambulatory blood test (finger stick) reported in patient

history

Other names: INR

Normal ranges: For a healthy person is 0.9-1.3. A high INR level such as INR=5 indicates that

there is a high chance of bleeding. A low level such as INR = 0.5 indicates a high chance of

abnormal clotting. Normal values may vary from lab to lab. Record the highest INR value prior to

treatment.

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00220: Liver (2018+)

3813: Bilirubin Pretreatment Total Lab Value

Item Length: 5

NAACCR Item #: 3813

XML Parent-NAACCR ID: Tumor-bilirubinPretxTotalLabValue

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

Bilirubin Pretreatment Total Lab Value records the bilirubin value prior to treatment. Bilirubin level is an

indicator of how effectively the liver excretes bile and is required to calculate the Model for End-Stage

Liver Disease (MELD) score used to assign priority for liver transplant.

Rationale

Bilirubin Pretreatment Total Lab Value is a Registry Data Collection Variable in AJCC. This data item was

previously collected as Liver, CS SSF #6.

See 3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score for additional

information

Coding Instructions and Codes

Note 1: Physician statement of Bilirubin Pretreatment Total Lab Value can be used to code this data item

when no other information is available.

Note 2: Record the lab value of the highest Bilirubin Total test results documented in the medical record

prior to treatment. The lab value may be recorded in a lab report, history and physical, or clinical

statement in the pathology report.

Note 3: Assay of Bilirubin Pretreatment Total Lab Value includes conjugated (direct) and unconjugated

(indirect) bilirubin and total bilirubin values. Record the total bilirubin value for this data item.

Note 4: Record to the nearest tenth of mg/dL or umol/L the highest total bilirubin value prior to

treatment.

Note 5: The Model for End-Stage Liver Disease (MELD) is a numerical scale used to determine how

urgently a patient with liver disease needs a liver transplant. Results from three routine lab tests are

used to calculate the MELD score. Bilirubin, one of the tests, measures how effectively the liver excretes

bile.

Note 6: The same laboratory test should be used to record information in 3814: Bilirubin Pretreatment

Unit of Measure.

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Code Description

0.0 0.0 milligram/deciliter (mg/dL)

0.0 micromole/liter (umol/L)

0.1-

999.9

0.1-999.9 milligram/deciliter (mg/dL)

0.1-999.9 micromole/liter (umol/L)

XXX.1 1000 milligram/deciliter (mg/dL) or greater

1000 micromole/liter (umol/L) or greater

XXX.7 Test ordered, results not in chart

XXX.8

Not applicable:

Information not collected

for this case

(If this item is required by your standard setter, use of code XXX.8 will result in an edit error.)

XXX.9

Not documented in medical record

Bilirubin Pretreatment Total Lab Value not assessed or unknown if assessed

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00220: Liver (2018+)

3814: Bilirubin Pretreatment Unit of Measure

Item Length: 1

NAACCR Item #: 3814

XML Parent-NAACCR ID: Tumor-bilirubinPretxUnitOfMeasure

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

Bilirubin Pretreatment Unit of Measure identifies the unit of measure for the bilirubin value measured

prior to treatment. Bilirubin is commonly measured in units of Milligrams/deciliter (mg/dL) in the United

States and Micromoles/liter (umol/L) in Canada and Europe.

Rationale

Bilirubin Pretreatment is a Registry Data Collection Variable in AJCC. Bilirubin Pretreatment Unit of

Measure is needed to identify the unit in which bilirubin is measured and was previously collected as

Liver, CS SSF #7.

See 3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score for additional

information

Coding Instructions and Codes

Note 1: Physician statement of Bilirubin Pretreatment Unit of Measure can be used to code this data

item when no other information is available.

Note 2: There are two main methods of describing concentrations: by weight, and by molecular count.

Weights are recorded in grams, and molecular counts are recorded in moles.

Milligrams/deciliter (mg/dL) is the unit of measure commonly used in the United States.

Micromoles/liter (umol/L) is the designated Systeme International (SI) unit of measure

commonly used in Canada and Europe.

1 mg/dL of bilirubin is 17.1 umol/L.

Note 3: The same laboratory test should be used to record information in 3813: Bilirubin Pretreatment

Total Lab Value.

Code

Description

1 Milligrams per deciliter (mg/dL)

2 Micromoles/liter (umol/L)

7 Test ordered, results not in chart

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Bilirubin unit of measure not assessed or unknown if assessed

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00220: Liver (2018+)

3824: Creatinine Pretreatment Lab Value

Item Length: 4

NAACCR Item #: 3824

XML Parent-NAACCR ID: Tumor-creatininePretreatmentLabValue

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

Creatinine Pretreatment Lab Value, an indicator of kidney function, is required to calculate the Model

for End-Stage Liver Disease (MELD) score, which is used to assign priority for liver transplant.

Rationale

Creatinine Pretreatment Lab Value is a Registry Data Collection Variable in AJCC. This data item was

previously collected for Liver, CS SSF #4.

See 3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score for additional

information

Coding Instructions and Code

Note 1: Physician statement of Creatinine Pretreatment Lab Value can be used to code this data item

when no other information is available.

Note 2: Record the lab value of the highest Creatinine test result documented in the medical record

prior to treatment. The lab value may be recorded in a lab report, history and physical, or clinical

statement in the pathology report.

Note 3: Record the blood or serum creatinine value for this data item. Do not use urine results to code

this data item.

Note 4: The Model for End-Stage Liver Disease (MELD) is a numerical scale used to determine how

urgently a patient with liver disease needs a liver transplant within the next three months. Results from

three routine lab tests are used to calculate the MELD score. Creatinine, one of the tests, measures

kidney function; impaired kidney function is often associated with severe liver disease.

Note 5: The same laboratory test should be used to record information in 3825: Creatinine Pretreatment

Unit of Measure.

Code Description

0.0

0.0 milligram/deciliter (mg/dl)

0.0 micromole/liter (umol/L)

0.1-99.9 0.1-99.9 milligram/deciliter (mg/dl)

0.1-99.9 micromole/liter (umol/L)

(Exact value to nearest tenth of mg/dl or umol/L)

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Code Description

XX.1 100 mg/dl or greater

100 umol/L or greater

XX.7 Test ordered, results not in chart

XX.8

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code XX.8 will result in an edit error.)

XX.9

Not documented in medical record

Creatinine Pretreatment Lab Value not assessed or unknown if assessed

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00220: Liver (2018+)

3825: Creatinine Pretreatment Unit of Measure

Item Length: 1

NAACCR Item #: 3825

XML Parent-NAACCR ID: Tumor-creatininePretxUnitOfMeasure

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

Creatinine Pretreatment Unit of Measure identifies the unit of measure for the creatinine value

measured in blood or serum prior to treatment. Creatinine is commonly measured in units of

Milligrams/deciliter (mg/dL) in the United States and Micromoles/liter (umol/L) in Canada and Europe.

Rationale

Creatinine Pretreatment is a Registry Data Collection Variable in AJCC. Creatinine Pretreatment Unit of

Measure is needed to identify the unit in which creatinine is measured and was previously collected as

Liver, CS SSF #5.

See 3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score for additional

information

Coding Instructions and Codes

Note 1: Physician statement of Creatinine Pretreatment Unit of Measure can be used to code this data

item when no other information is available.

Note 2: There are two main methods of describing concentrations: by weight, and by molecular count.

Weights are recorded in grams, and molecular counts are recorded in moles.

Milligrams/deciliter (mg/dL) is the unit of measure commonly used in the United States

Micromoles/liter (umol/L) is the designated Systeme International (SI) unit of measure

commonly used in Canada and Europe.

1 mg/dL of creatinine is 88.4 umol/L.

Note 3: The same laboratory test should be used to record information in 3824: Creatinine Pretreatment

Lab Value.

Code

Description

1 Milligrams/deciliter (mg/dL)

2 Micromoles/liter (umol/L)

7 Test ordered, results not in chart

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Creatinine unit of measure not assessed or unknown if assessed

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00220: Liver (2018+)

3860: International Normalized Ratio

Item Length: 3

NAACCR Item #: 3860

XML Parent-NAACCR ID: Tumor-iNRProthrombinTime

NAACCR Alternate Name: INR (International Normalized Ratio for Prothrombin Time)

Active years: 2018+

Schema(s):

00220: Liver (2018+)

Description

International Normalized Ratio for Prothrombin Time (INR), an indicator of the liver’s ability to make

clotting factors, is required to calculate the Model for End-Stage Liver Disease (MELD) score, is used to

assign priority for liver transplant.

Rationale

International Normalized Ratio for Prothrombin Time (INR) is a Registry Data Collection Variable in AJCC.

This data item was previously collected for Liver, CS SSF #8.

See 3813-3814, 3824-3825, 3860: Model for End-Stage Liver Disease (MELD) Score for additional

information

Coding Instructions and Codes

Note 1: Physician statement of the International Normalized Ratio for Prothrombin Time (INR) can be

used to code this data item when no other information is available.

Note 2: Record the value of the highest INR test results documented in the medical record prior to

treatment. The value may be recorded in a lab report, history and physical, or clinical statement in the

pathology report.

Note 3: The Model for End-Stage Liver Disease (MELD) is a numerical scale used to determine how

urgently a patient with liver disease needs a liver transplant. Results from three routine lab tests are

used to calculate the MELD score. International normalized ratio for prothrombin time (INR), one of the

tests, measures the liver's ability to make blood clotting factors.

Code Description

0.0 0.0

0.1

0.1 or less

0.2

9.9

0.2

9.9

(Exact ratio to nearest tenth)

X.1

10 or greater

X.7 Test ordered, results not in chart

X.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X.8 may result in an edit error.)

X.9 Not documented in medical record

INR (International Normalized Ratio for Prothrombin Time) not assessed or unknown if assessed

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00220: Liver (2018+)

3835: Fibrosis Score

Item Length: 1

NAACCR Item #: 3835

XML Parent-NAACCR ID: Tumor-fibrosisScore

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00220: Liver (2018+)

00230: Bile Ducts Intrahepatic (2018+)

Description

Fibrosis Score (Ishak Score), the degree of fibrosis of the liver based on pathological examination, is a

prognostic factor for liver cancer.

Rationale

Fibrosis Score is a Registry Data Collection Variable in AJCC. This data item was previously collected for

Liver, CS SSF #2.

Definition

The Fibrosis Score is based on degree of parenchymal fibrosis or cirrhosis of the nontumorous liver as

defined in the surgical pathology report. Multiple fibrosis scoring systems have been described for use in

pathological evaluation of liver disease.

Ishak system uses a scale of 0-6 with 6 indicating cirrhosis.

o Recommended by AJCC and CAP

Batts-Ludwig system uses a score of 0-4, with a score of 3 defined as fibrous septa with

architectural distortion but no obvious cirrhosis, and a score of 4 defined as cirrhosis

o Used most commonly by US pathologists

METAVIR uses scores of F0-F4

o Used mostly in Europe

Additional Information

Source documents: pathology report (biopsy or FNA path report), surgical resection

Other names: Nontumoral hepatic parenchymal fibrosis/cirrhosis (Intrahepatic Bile Duct

Tumors)

Coding Instructions and Codes

Note 1: Physician statement of fibrosis score can be used to code this data item when no other

information is available. However, code 7 when the physician statement of fibrosis score is not based on

histologic examination of the liver.

Note 2: FIB-4 is NOT a pathological fibrosis score of 4. It is a scoring method using the patient’s age and

relevant lab values to calculate a score. The medical record may show something like “FIB-4 = 3.52.” Do

not code FIB-4 values in this data item.

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Note 3: AJCC classifies Ishak fibrosis scores 0-4 (none to moderate fibrosis) as F0, and Ishak fibrosis

scores 5-6 (cirrhosis/severe fibrosis) as F1. This is not the same as METAVIR score F0 or F1.

Note 4: Record the results based on information collected during the initial work-up through the first

course surgery, in the absence of neoadjuvant treatment. If multiple histologic assessments of the liver

(biopsies or resections) are taken and have conflicting scores, record the highest score.

Information collected after the start of neoadjuvant treatment or primary systemic or radiation

therapy may not be used to code this data item.

Note 5: To use codes 0 and 1, you must have a histological (microscopic) confirmation of

fibrosis/cirrhosis. Code the absence (code 0) or presence (code 1) of fibrosis as documented in the

pathology report.

Note 6: Use code 7 if there is a clinical diagnosis (no microscopic confirmation) of severe fibrosis or

cirrhosis.

Note 7: If no score is mentioned, descriptive terms may be used to assign codes 0 and 1 – see specific

terms in the table below.

Note 8: If a fibrosis score is stated but the scoring system is not recorded, consult with the physician. If

no further information is available, code 9.

Code Description

Any of the following histologically confirmed

No to moderate fibrosis

Ishak fibrosis score 0-4

METAVIR score F0-F3

Batt-Ludwig score 0-3

Any of the following histologically confirmed

Advanced/severe fibrosis

Developing cirrhosis

Incomplete cirrhosis

Transition to cirrhosis

Cirrhosis, probably or definite

Cirrhosis, NOS

Ishak fibrosis score 5-6

METAVIR score F4

Batt-Ludwig score 4

Clinical statement of advanced/severe fibrosis or cirrhosis, AND

Not histologically confirmed or unknown if histologically confirmed

Not applicable: Information not collected for this

case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Stated in medical record that patient does not have advanced cirrhosis/advanced fibrosis, not

histologically confirmed or unknown if histologically confirmed

Fibrosis score stated but cannot be assigned to codes 0 or 1

Fibrosis score stated but scoring system not recorded

Fibrosis Score not assessed or unknown if assessed

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002300: Bile Ducts Intrahepat (2018+)

See 00220: Liver (2018+)

3835: Fibrosis Score

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00230: Bile Ducts Intrahepatic (2018+)

3917: Primary Sclerosing Cholangitis

Item Length: 1

NAACCR Item #: 3917

XML Parent-NAACCR ID: Tumor-primarySclerosingCholangitis

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00230: Bile Ducts Intrahepatic (2018+)

00250: Bile Ducts Perihilar (2018+)

Description

Primary sclerosing cholangitis denotes a chronic autoimmune inflammation of the bile ducts that leads

to scar formation and narrowing of the ducts over time. It is a prognostic factor for intrahepatic bile duct

cancer.

Rationale

Primary Sclerosing Cholangitis is a Registry Data Collection Variable in AJCC. This data item was

previously collected for Intrahepatic Bile Duct, SSF #11.

Definition

Primary sclerosing cholangitis is an idiopathic liver disease characterized by inflammation and fibrosis of

the entire biliary tree. The chronic inflammation and injury to ducts may lead to cirrhosis and predispose

to cholangiocarcinoma at any site in the biliary tree. Patients with primary sclerosing cholangitis are

advised to receive neoadjuvant chemoradiation and liver transplantation.

Coding guidelines

Record whether primary sclerosing is absent or present

Code 0 when there is a statement in the pathology report that primary sclerosing cholangitis is

not present

Code 1 when the pathology report states that primary sclerosing cholangitis is present

Code 9 when

o No information in the medical record

o Pathology report is not available

o Primary Sclerosing Cholangitis is not evaluated (not assessed)

o Unknown if Primary Sclerosing Cholangitis is evaluated (assessed)

Additional Information

Source documents: patient history, pathology report, imaging reports

Other names: PSC, fibrosing cholangitis, chronic obliterative cholangitis, sclerosing cholangitis

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of primary sclerosing cholangitis, the registrar could assume that it was not

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present and code appropriately. For the SSDI, this assumption cannot be made. There must be a

statement that primary sclerosing cholangitis is not present to code 0.

Coding Instructions and Codes

Note 1: Physician statement of Primary Sclerosing Cholangitis (PSC) can be used to code this data item

when no other information is available.

Note 2: PSC is an idiopathic liver disease characterized by inflammation and fibrosis of the entire biliary

tree. The chronic inflammation and injury to ducts may lead to cirrhosis and predispose to

cholangiocarcinoma at any site in the biliary tree.

Note 3: Code stated diagnosis of PSC either clinically or pathologically as documented in the medical

record. This may be by history.

Note 4: Code 9 if there is no mention of primary sclerosing cholangitis (PSC).

Code Description

0 PSC not identified/not present

1 PSC present

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

PSC not assessed or unknown if assessed

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00230: Bile Ducts Intrahepatic (2018+)

3935: Tumor Growth Pattern

Item Length: 1

NAACCR Item #: 3935

XML Parent-NAACCR ID: Tumor-tumorGrowthPattern

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00230: Bile Ducts Intrahepatic (2018+)

Description

Tumor Growth Pattern refers to the growth pattern of intrahepatic cholangiocarcinoma.

Rationale

Tumor Growth Pattern is a Registry Data Collection Variable in AJCC. This data item was previously

collected for Intrahepatic Bile Duct, SSF #10.

Definition

There are two types of growth patterns for intrahepatic bile duct carcinomas.

Mass-forming (60% of intrahepatic bile duct cases), which grows outward (radially) from the

duct and invades the liver parenchyma in a well-defined mass.

Periductal infiltrating type (20%): spreads along the duct in a diffuse manner that may be

associated with poorer prognosis.

Coding guidelines

Record the specific type of tumor growth pattern.

Code 1 when a radiology, surgery, or pathology report describes the tumor as mass-forming only

Code 2 when a radiology, surgery, or pathology report describes the tumor as periductal

infiltrating only

Code 3 when a radiology, surgery, or pathology reports mentions both mixed mass forming and

periductal infiltrating

Code 9

Not documented in the medical record

Tumor growth pattern not evaluated (assessed)

Unknown if Tumor Growth Pattern evaluated (assessed)

Additional Information

Source documents: radiology, surgery, or pathology report

Coding Instructions and Codes

Note 1: Physician statement of tumor growth pattern can be used to code this data item when no other

information is available.

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Note 2: Cholangiocarcinoma may be classified by growth pattern. The tumor growth patterns of

intrahepatic cholangiocarcinoma include the mass forming type, the periductal infiltrating type, and a

mixed type. The periductal infiltrating type of cholangiocarcinoma demonstrates a diffuse longitudinal

growth pattern along the bile duct. Limited analyses suggest that the diffuse periductal infiltrating type

is associated with a poor prognosis.

Note 3: Record the presence or absence of an infiltrating periductal component. This information may

be obtained from radiology, surgery, or pathology reports.

Code Description

1 Mass-forming

2 Periductal infiltrating

3 Mixed mass-forming and periductal infiltrating

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

Radiology and/or pathology report does not mention tumor growth pattern

Cannot be determined by the pathologist

Tumor growth pattern not assessed or unknown if assessed

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00242: Cystic Duct (2018+)

3926: Schema Discriminator 1: BileDuctsDistal/BileDuctsPerihilar/CysticDuct

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00242: Cystic Duct (2018+)

00250: Bile Ducts Perihilar (2018+)

00260: Bile Duct Distal (2018+)

Definition

Cystic duct, distal bile ducts, and perihilar bile ducts all have the same ICD-O topography code (C240).

However, for purposes of stage grouping in the AJCC 8

edition, they each have different chapters for

stage. A schema discriminator is necessary to distinguish between these primary sites so that the

appropriate chapter/schema is used.

Coding Instructions and Codes

Note: A schema discriminator is used to discriminate for primary site C240 (extrahepatic bile ducts) for

the subsite in which the tumor arose.

00242: Cystic Duct (see code 3)

Per the AJCC Gallbladder Staging System, the gallbladder tapers into the cystic duct

00250: Bile Ducts Perihilar (see codes 1, 5, 6, 9)

Per the AJCC Perihilar Bile Ducts Staging System, perihilar (or proximal) cholangiocarcinomas

involve the main biliary confluence of the right and left hepatic ducts and comprise 50%-70% of

all cases of bile duct carcinoma

00260: Bile Ducts Distal (see codes 4, 7)

Per the AJCC Distal Bile Duct Staging System, these tumors have their center located between

the confluence of the cystic duct and common hepatic duct and the Ampulla of Vater (excluding

ampullary carcinomas)

Code Description Schema ID#/Description

1 Perihilar bile duct(s)

Proximal extrahepatic bile duct(s)

Hepatic duct(s)

00250: Bile Ducts Perihilar

3 Cystic bile duct; cystic duct 00242: Cystic Duct

Distal bile duct

Common bile duct

Common duct, NOS

00260: Bile Duct Distal

Diffuse involvement

More than one subsite involved, subsite of origin not stated

00250: Bile

Ducts Perihilar

Stated as middle extrahepatic bile duct

AND treated with combined hepatic and hilar resection

00250: Bile Ducts Perihilar

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Code Description Schema ID#/Description

7 Stated as middle extrahepatic bile duct

AND treated with pancreaticoduodenectomy

00260: Bile Duct Distal

9 Extrahepatic bile ducts, NOS 00250: Bile Ducts Perihilar

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00250: Bile Ducts Perhilar (2018+)

See 00242: Cystic Duct (2018+)

3926: Schema Discriminator 1: BileDuctsDistal/BileDuctsPerihilar/CysticDuct

See 00230: Bile Ducts Intrahepatic

3917: Primary Sclerosing Cholangitis

00260: Bile Duct Distal (2018+)

See 00242: Cystic Duct (2018+)

3926: Schema Discriminator 1: BileDuctsDistal/BileDuctsPerihilar/CysticDuct

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00280: Pancreas (2018+)

3942: CA 19-9 PreTx Lab Value

Item Length: 6

NAACCR Item #: 3942

XML Parent-NAACCR ID: Tumor-ca199PretxLabValue

Alternate Name: Carbohydrate Antigen 19-9 Pretreatment Lab Value

Active years: 2021+

Schema(s):

00280: Pancreas (2018+)

Description

Carbohydrate Antigen (CA) 19-9 Pretreatment Lab Value records the CA 19-9 value prior to treatment.

CA 19-9 is a tumor marker that has prognostic significance for pancreatic cancer.

Rationale

CA 19-9 Pretreatment Lab Value is a strong predictor of resectability in the absence of metastatic

disease. It is a new data item for cases diagnosed 1/1/2021+.

Definition

CA 19-9 is a sialylated Lewis A blood group antigen that is commonly expressed and shed in pancreatic

and hepatobiliary disease and in many malignancies, thus is not tumor specific. Preoperative CA 19-9

levels in pancreatic cancer patients correlate both with AJCC staging and resectability [NCCN Guidelines

Version 3.2019 Pancreatic Adenocarcinoma].

Additional Information

Source documents: clinical laboratory report

Other names: Carbohydrate Antigen 19-9, Cancer Antigen-GI, CA-GI, Cancer Antigen 19-9

https://labtestsonline.org/tests/cancer-antigen-19-9#

Coding Instructions and Code

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of CA 19-9 (Carbohydrate Antigen 19-9) Pretreatment Lab Value can be

used to code this data item when no other information is available.

Note 3: Record the lab value of the highest CA 19-9 test result documented in the medical record prior

to treatment. The lab value may be recorded in a lab report, history and physical, or clinical statement

in the pathology report.

Note 4: A known lab value takes priority over codes XXXX.2 and XXXX.3

The lab value takes priority even if the physician documents the interpretation

Example: Patient noted to have a CA 19-9 of 3,219. Physician notes that the value is elevated.

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o Code 3219.0 instead of XXXX.3 (elevated)

Note 5: CA 19-9 is a tumor marker that has value in the management of certain malignancies.

Note 6: Record to the nearest tenth in Units/milliliter (U/ml), the highest CA 19-9 lab value documented

in the medical record prior to treatment.

Example 1: Code a pretreatment CA 19-9 of 7 U/ml as 7.0

Example 2: Code a pretreatment CA 19-9 of 1672.3 U/ml as 1672.3

Note 7: Record 0.1 when the lab results are stated as less than 0.1 U/ml with no exact value.

Code Description

0.0 0.0 Units/milliliter (U/ml) exactly

0.1-

9999.9

0.1-9999.9 U/ml

(Exact value to nearest tenth in U/ml)

XXXX.1 10,000 U/ml or greater

XXXX.2 Lab value not available, physician states CA 19-9 is negative/normal

XXXX.3 Lab value not available, physician states CA 19-9 is positive/elevated/high

XXXX.7 Test ordered, results not in chart

XXXX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XXXX.8 may result in an edit error.)

XXXX.9 Not documented in medical record

CA (Carbohydrate Antigen) 19-9 Pretreatment Lab Value not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is prior to 2021

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00290: NET Stomach (2018+)

3863: Ki-67

Item Length: 5

NAACCR Item #: 3863

XML Parent-NAACCR ID: Tumor-ki67

Active years: 2021+

Schema(s):

00290: NET Stomach (2018+)

00301: NET Duodenum (2018+)

00302: NET Ampulla of Vater (2018+)

00310: NET Jejunum and Ileum (2018+)

00320: NET Appendix (2018+)

00330: NET Colon and Rectum (2018+)

00340: NET Pancreas (2018+)

Description

Ki-67 (MIB-1) (Proliferative Index) is a marker of cell proliferation. A high value indicates a tumor that is

proliferating more rapidly. Codes and coding instructions for this data item are site-specific.

Rationale

Ki-67 (MIB-1) (Proliferative Index) is a Registry Data Collection Variable in AJCC. It was a new data item

for breast cases diagnosed 1/1/2018+. It will apply to neuroendocrine tumors (NET) of the

gastrointestinal tract (AJCC Chapters 29 – 34) for cases diagnosed 1/1/2021+. High Ki-67 is an adverse

prognostic factor and Ki-67 is a component of grade for these tumors. NCCN guidelines recommend

that tumor differentiation, mitotic rate and Ki-67 should be recorded in the pathology report for these

tumors.

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of Ki-67 (MIB-1), also referred to as the “Proliferative Index” can be used to

code this data item.

Note 3: Ki-67 is a marker of cell proliferation. A high value indicates a tumor that is proliferating more

rapidly.

Note 4: Results from nodal or metastatic tissue may not be used.

If the only information you have have is a Ki-67 from a metastatic site, code to XXX.9

Note 5: Ki-67 results are reported as the percentage cell nuclei that stain positive. As of early 2017,

there are no established standards for interpretation of results or for cutoffs for positive and negative.

Example 1: Ki-67 reported as 14%. Code 14.0

Example 2: Ki-67 reported as 8.6%. Code 8.6

Note 6: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

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If neoadjuvant therapy is given and there are no Ki-67 results from pre-treatment specimens,

report the findings from post-treatment specimens

Note 7: A specific value (0.0-100.0) takes priority over XXX.4, XXX.5 or XXX.6. Code the exact percentage

when provided. When the exact percentage is not given, including ranges or terms such as “less than” or

“greater than” use the range value codes XXX.4, XXX.5, XXX.6.

XXX.4, XXX.5 and XXX.6 were added since they are listed on the CAP protocol

o Example 1: Ki-67 stated as less than 1%. Code XXX.4

o Example 2: Ki-67 stated as 5%-10%. Code XXX.5

o Example 3: Ki-67 stated as greater than 4%. Code XXX.5

o Example 4: Ki-67 stated as greater than 30%. Code XXX.6

Code Description

0.0-100.0 0.0 to 100.0 percent positive: enter percent positive

XXX.4 Ki-67 stated as less than 3%

XXX.5 Ki-67 stated as 3%-20%

XXX.6 Ki-67 stated as greater than 20%

XXX.7 Test done; actual percentage not stated

XXX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XXX.8 will result in an edit error.)

XXX.9 Not documented in medical record

Ki-67 (MIB-1) not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is prior to 2021

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00301: NET Duodenum (2018+)

See 00290: NET Stomach (2018+)

3863: Ki-67

00302: NET Ampulla of Vater (2018+)

See 00290: NET Stomach (2018+)

3863: Ki-67

00310: NET Jejunum and Ileum (2018+)

See 00290: NET Stomach (2018+)

3863: Ki-67

00320: NET Appendix (2018+)

See 00290: NET Stomach (2018+)

3863: Ki-67

00330: NET Colon and Rectum (2018+)

See 00290: NET Stomach (2018+)

3863: Ki-67

00340: NET Pancreas (2018+)

See 00290: NET Stomach (2018+)

3863: Ki-67

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THORAX

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00360: Lung (2018+)

3929: Separate Tumor Nodules

Item Length: 1

NAACCR Item #: 3929

XML Parent-NAACCR ID: Tumor-separateTumorNodules

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00360: Lung (2018+)

Description

“Separate tumor nodules” refers to what is conceptually a single tumor with intrapulmonary metastasis

in the ipsilateral (same) lung. Their presence in the same or different lobes of lung from the primary

tumor affects the T and M categories.

Rationale

This data item was previously collected for Lung, SSF #1 and at least one standard setter is continuing to

collect it.

Definition

Separate tumor nodules are defined as intrapulmonary metastasis identified in the same lobe or same

lung (ipsilateral) originating from a single lung primary at the time of diagnosis. Biopsy of tumors may or

may not be performed. So long as there is a strong suspicion the multiple lesions are of the same

histological type by imaging, physician judgement, or microscopically, this meets the criteria of separate

tumor nodules representing intrapulmonary metastases. The presence of metastases to extrathoracic

sites does not change this distinction.

Coding guidelines

Record the presence of separate tumor nodules within the same ipsilateral lobe and/or different lobes

of the same lung which are considered a single primary. The histology of the separate tumors must be

the same. Histology may be determined clinically (presumed to be the same based on imaging or

physician judgement) or microscopically confirmed.

Code 0 when

o SINGLE TUMOR nodule only

o Separate tumor nodules present with DIFFERENT HISTOLOGIES

Code 1 when

o Separate tumor nodules present in the SAME LOBE with the SAME HISTOLOGY

Code 2 when

o Separate tumor nodules present in DIFFERENT LOBES of the SAME LUNG (ipsilateral)

with the SAME HISTOLOGY.

Code 3 when

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o Separate tumor nodules present in SAME LOBE AND DIFFERENT LOBES of the SAME

LUNG with the SAME HISTOLOGY.

Code 4 when

o Separate tumor nodules present in SAME LUNG with the SAME HISTOLOGY and it’s

UNKNOWN IF they are in the SAME LOBE OR DIFFERENT LOBES.

Additional Information

Source documents: imaging reports and pathology reports

Coding Instructions and Codes

Note 1: Physician statement of Separate Tumor Nodules in the ipsilateral (same) lung can be used to

code this data item when no other information is available. See discussion of terminology in Note 4.

Separate tumor nodules in the contralateral lung are not coded in this data item.

Note 2: Code the presence and location of separate tumor nodules, also known as intrapulmonary

metastasis, at the time of diagnosis in this item. Separate tumor nodules can be defined clinically (by

imaging) and/or pathologically. They can be in the same or different lobes of the same lung as the

primary tumor. Their location is used to assign the T in the TNM system.

Note 3: For this item, only code separate tumor nodules of the same histologic type as the primary

tumor, also referred to as intrapulmonary metastases.

In the case of multiple tumor nodules determined to be the same primary, if not all nodules are

biopsied, assume they are the same histology

Note 4: Other situations that display multiple lesions are NOT coded in this item. Assign code 0 if the

multiple lesions belong to one of these other situations. Refer to the AJCC Staging System Lung for

standardized and precise definitions of the situations which aren’t separate tumor nodules. They are

second primary tumors, also called synchronous primary tumors (not the same histology as the

primary tumor)

multifocal lung adenocarcinoma with ground glass/lepidic features

diffuse pneumonic adenocarcinoma

Note 5: “Synchronous” describes the appearance in time compared to the primary tumor. Do not code

this item based solely on the word “synchronous”. If separate nodules are described as “metachronous,”

the nodules may be evidence of progression of disease in which case they would not be coded here.

Note 6: If there are multiple tumor nodules or foci and the terminology used is not readily identifiable as

one of the situations described in Note 4, consult with the pathologist or clinician. If no further

information is available, assign code 7 and DO NOT use the information to assign a T category or extent

of disease.

Note 7: Code 0 if relevant imaging or resection is performed and there is no mention of separate tumor

nodules.

Note 8: Code 9 if there is no relevant imaging or resection of the primary site.

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Code Description

0 No separate tumor nodules; single tumor only

Separate tumor nodules of same histologic type not identified/not present

Intrapulmonary metastasis not identified/not present

Multiple nodules described as multiple foci of adenocarcinoma in situ or minimally invasive

adenocarcinoma

Non-invasive neoplasm (behavior /2)

1 Separate tumor nodules of same histologic type in ipsilateral lung, same lobe

2 Separate tumor nodules of same histologic type in ipsilateral lung, different lobe

3 Separate tumor nodules of same histologic type in ipsilateral lung, same AND different lobes

4 Separate tumor nodules of same histologic type in ipsilateral lung, unknown if same or

different lobe(s)

7 Multiple nodules or foci of tumor present, not classifiable based on Notes 3 and 4

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Separate Tumor Nodules not assessed or unknown if assessed

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00360: Lung (2018+)

3937: Visceral and Parietal Pleural Invasion

Item Length: 1

NAACCR Item #: 3937

XML Parent-NAACCR ID: Tumor-visceralParietalPleuralInvasion

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00360: Lung (2018+)

Description

Visceral and Parietal Pleural Invasion is defined as invasion beyond the elastic layer or to the surface of

the visceral pleura.

Rationale

Visceral and Parietal Pleural Invasion (previously called “pleural/elastic layer invasion (PL)”) is a Registry

Data Collection Variable for AJCC. This data item was previously collected for Lung, SSF #2.

Definition

Invasion of one or more layers of the pleura covering the lung (visceral pleura), such as invasion beyond

the elastic layer of the pleura. The elastic layer may be identified on hematoxylin and eosin (H&E) stains

or by special stains looking for the elastic fibers. An elastic stain is not needed in most cases to assess

the pleura for invasion, only in those cases where the distinction between PL0 and PL1 is unclear on H&E

sections. Elastic stains may also be helpful in cases where the visceral and parietal pleura are adherent,

making it difficult to identify the boundary between the visceral pleural surface and the parietal pleura.

VPI is relevant for peripheral lung tumors. The presence of visceral pleural invasion by tumors smaller

than 3 cm changes the T category from pT1 to pT2 and increases the stage from IA to IB in patients with

no nodal disease or stage IIA to IIB in patients with peribronchial or hilar nodes. Studies have shown that

tumors smaller than 3 cm that penetrate beyond the elastic layer of the visceral pleura behave similarly

to similar-size tumors that extend to the visceral pleural surface. Visceral pleural invasion should

therefore be considered present not only in tumors that extend to the visceral pleural surface, but also

in tumors that penetrate beyond the elastic layer of the visceral pleura. Four to six layers of visceral

pleura may be described by the pathologist.

Coding guidelines

Record results of visceral pleural invasion as stated on pathology report. Do not code separate pleural

tumor foci or nodules in this field (discontinuous pleural metastasis).

Code 0 when

o No evidence of visceral and parietal pleural invasion or described as PL0

o Tumor does not penetrate beyond the elastic layer of the visceral pleura

o Extends to the elastic layer

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Code 4 when

o Invasion of pleura without specifying visceral or parietal pleura

o Uncertain whether elastic stain has been performed to identify visceral pleura invasion

o Pathology report states PL1 or PL2

Code 5 when tumor extends to the parietal pleura (classified as T3) or described as PL3

Code 9 when

o No information in the medical record

o Only FNA performed

o Pathology report is not available

o Visceral and Parietal Pleural Invasion not evaluated (not assessed)

o Unknown if Visceral and Parietal Pleural Invasion evaluated (assessed)

Additional Information

Source documents: pathology report

For further information, refer to the Lung cancer protocol published by the College of American

Pathologists for the AJCC Staging System Lung

Other names: VPI, PL (number)

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of visceral pleural invasion, the registrar could assume that it was negative and

code appropriately. For the SSDI, this assumption cannot be made. There must be a statement

that visceral pleural invasion is not present to code 0

Coding Instructions and Codes

Note 1: Physician statement of Visceral and Parietal Pleural Invasion can be used to code this data item

when no other information is available.

Note 2: A surgical resection must be done to determine if the visceral and/or parietal pleural are

involved.

Note 3: Do not use imaging findings to code this data item

Note 4: Code 9 when

A FNA only is performed. A FNA is not adequate to assess pleural layer invasion

Surgical resection of the primary site is performed and there is no mention of visceral and/or

parietal pleural invasion

Code Description

0 No evidence of visceral pleural invasion identified

Tumor does not completely traverse the elastic layer of the pleura

Stated as PL0

Primary tumor is in situ

Non-invasive neoplasm (behavior /2)

No evidence of primary tumor

4 Invasion of visceral pleura present, NOS

Stated as PL1 or PL2

5 Tumor invades into or through the parietal pleura OR chest wall

Stated as PL3

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Code Description

6 Tumor extends to pleura, NOS; not stated if visceral or parietal

Not applicable:

Information not

collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

No surgical resection of primary site is performed

Visceral Pleural Invasion not assessed or unknown if assessed or cannot be determined

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00360: Lung (2018+)

3938: ALK Rearrangement

Item Length: 1

NAACCR Item #: 3938

XML Parent-NAACCR ID: Tumor-alkRearrangement

Active years: 2021+

Schema(s):

00360: Lung (2018+)

Description

Testing for ALK rearrangement is performed for patients with advanced non-small cell lung cancer

(NSCLC) to identify tumors which are sensitive to small-molecule ALK kinase inhibitors.

Rationale

ALK rearrangement is recommended by treatment guidelines for patients with advanced lung cancer to

as a prognostic marker and factor in determining appropriate therapy. It is a new data item for cases

diagnosed 1/1/2021+.

Definition

“ALK positive cancer describes cancer cells that have a change in the structure of the anaplastic

lymphoma kinase (ALK) gene or a higher than normal amount of ALK protein on their surface. In normal

cells, ALK helps control cell growth. When cancer cells have the changed ALK gene or make too much

ALK protein, the cancer cells may grow more quickly. Knowing whether a cancer is ALK positive may help

plan treatment for advanced non-small cell cancers in the lung.” (NCI Dictionary of Cancer Terms

https://www.cancer.gov/publications/dictionaries/cancer-terms)

The presence of the ALK protein predicts a favorable response to therapy with a targeted ALK inhibitor,

such as crizotinib or ceritinib (chemotherapy).

Additional Information

Source documents: pathology report or clinical laboratory report, molecular report,

immunohistochemistry report

Other names: ALK tyrosine kinase receptor, anaplastic lymphoma kinase, anaplastic lymphoma

receptor tyrosine kinase, CD246, CD246 antigen, NBLST3

For further information, refer to the Lung Biomarker Reporting cancer protocol published by

the College of American Pathologists for the AJCC Staging System Lung

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of ALK rearrangement for non-small cell carcinoma can be used to code this

data item when no other information is available.

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This data item only includes rearrangements. Ignore any amplifications or point mutations

Note 3: ALK may be recorded for all histologies and stages; however, it is primarily performed for

advanced non-small cell carcinomas. If information is not available, code 9.

Note 4: The absence or presence of ALK protein expression determines if the tumor will respond to

treatment with a targeted inhibitor. ALK protein expression predicts the ALK rearrangement gene, which

are more likely to respond to the targeted inhibitor treatment. The most common ALK rearrangements

are

EML4-ALK

KIF5B-ALK

TFG-ALK

KLC1-ALK

Note 5: If ALK Rearrangement is positive and there is no mention of the specific rearrangement, code 4.

Note 6: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no ALK results from pre-treatment specimens,

report the findings from post-treatment specimens

Note 7: Code 9 when

Insufficient amount of tissue available to perform test

Test done and documented to be equivocal

No microscopic confirmation of tumor

ALK Rearrangement not ordered or not done, or unknown if ordered or done

Code Description

0 Normal

ALK negative

Negative for rearrangement, no rearrangement identified, no mutations (somatic)

identified, not present, not detected

1 Abnormal Rearrangement identified/detected: EML4-ALK, KIF5B-ALK, TFG-ALK, and/or

KLC1-ALK

2 Rearrangement identified/detected: Other ALK Rearrangement not listed in code 1

4 Rearrangement, NOS

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

Not documented in medical record

ALK Rearrangement not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is prior to 2021

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00360: Lung (2018+)

3939: EGFR Mutational Analysis

Item Length: 1

NAACCR Item #: 3939

XML Parent-NAACCR ID: Tumor-egfrMutationalAnalysis

Active years: 2021+

Schema(s):

00360: Lung (2018+)

Description

Epidermal growth factor receptor (EGFR) mutational analysis is performed for patients with advanced

non-small cell lung cancer (NSCLC) to identify patients with certain activating mutations in the EGFR

gene which are sensitive to tyrosine kinase Inhibitors.

Rationale

EGFR mutational analysis is recommended by treatment guidelines for patients with advanced lung

cancer as a prognostic marker and factor in determining appropriate therapy. It is a new data item for

cases diagnosed 1/1/2021+.

Definition

“EGFR (epidermal growth factor receptor) is a protein found on certain types of cells that binds to a

substance called epidermal growth factor. The EGFR protein is involved in cell signaling pathways that

control cell division and survival. Sometimes, mutations (changes) in the EGFR gene cause EGFR proteins

to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to

divide more rapidly.” (NCI Dictionary of Cancer Terms

https://www.cancer.gov/publications/dictionaries/cancer-terms)

The presence of Exon 20 EGFR activating mutations are associated with a resistance to EGFR tyrosine

kinase inhibits, such as erlotinib, afatinib, and gefitinib. There is limited data available on response for

some of the other uncommon EGFR mutations (other than Exon 20). (CAP Cancer Protocol).

Additional Information

Source documents: pathology report or clinical laboratory report

Other names: Epidermal growth factor receptor tyrosine kinase inhibitor, ERBB, ERBB1, ErbB1,

HER1

For further information, refer to the Lung Biomarker Reporting cancer protocol published by

the College of American Pathologists for the AJCC Staging System Lung

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Physician statement of EGFR can be used to code this data item when no other information is

available.

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Note 3: EGFR may be recorded for all histologies and stages; however, it is primarily performed for

advanced non-small cell carcinomas. If information is not available, code 9.

Note 4: The most common EGFR mutations are

Exon 18 Gly719

Exon 19 deletion

Exon 20 insertion

Exon 20 Thr790Met

Exon 21 Leu858Arg

Note 5: If EGFR is positive and there is no mention of the mutated codon, or the mutated codon is not

specified, code 4.

Note 6: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no EGFR results from pre-treatment specimens,

report the findings from post-treatment specimens

Note 7: Code 9 when

Insufficient amount of tissue available to perform test

No microscopic confirmation of tumor

EGFR not ordered or not done, or unknown if ordered or done

Code Description

0 Normal

EGFR negative, EGFR wild type

Negative for mutations, no alterations, no mutations (somatic) identified, not present, not

detected

1 Abnormal (mutated)/detected in exon(s) 18, 19, 20, and/or 21

2 Abnormal (mutated)/detected but not in exon(s) 18, 19, 20, and/or 21

4 Abnormal (mutated)/detected, NOS, exon(s) not specified

7 Test ordered, results not in chart

Not

applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

Not documented in medical record

EGFR not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is prior to 2021

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00370: Pleura Mesothelioma (2018+)

3913: Pleural Effusion

Item Length: 1

NAACCR Item #: 3913

XML Parent-NAACCR ID: Tumor-pleuralEffusion

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00370: Pleural Mesothelioma (2018+)

Description

Pleural effusion is the accumulation of fluid between the parietal pleura (the pleura covering the chest

wall and diaphragm) and the visceral pleura (the pleura covering the lungs).

Rationale

Pleural Effusion can be collected by the surveillance community for pleura cancers. Prior to 2018, Pleura

SSF #1 was used for Pleural Effusion.

Definition

Pleural effusion is the accumulation of fluid between the two layers of pleura: visceral (covering the

lungs) and parietal (lining the chest wall and covering the diaphragm). Pleural effusion is a symptom of

mesothelioma that increases the Summary Stage from local or regional direct extension to distant

involvement.

Additional Information

Source documents: imaging, pathology and cytology reports

Other names: pleural fluid, thoracentesis

Coding guidelines

Record the absence or presence of pleural effusion. If pleural effusion is present and examined

microscopically, record whether the pleural effusion is non-malignant, malignant, or not specified.

Code 0 when there is no evidence of pleural effusion

Code 1 when

o Pleural effusion microscopically confirmed to be non-malignant

o Pleural effusion is stated to be negative for malignant cells

o Pleural effusion is seen on imaging, but pleural fluid cytology is negative for malignant

cells

Code 2 when

o Pleural effusion microscopically confirmed to be malignant

o Pleural effusion is stated to be positive for malignant cells

o Pleural fluid cytology described as suspicious or suspicious for mesothelioma

o Physician states pleural effusion is positive in the absence of positive cytology

Code 3 when

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o Pleural fluid cytology is described as atypical or atypical mesothelial cells but not

specifically as non-malignant or malignant)

Code 4 when

o Pleural effusion is reported on imaging, but there is no cytology

o Pleural effusion is reported on imaging, but there is no physician’s statement on

whether it is positive

Code 9 when

o Not documented in the medical report

o Pleural effusion not evaluated (assessed)

o Unknown if Pleural Effusion evaluated (assessed)

Coding Instructions and Codes

Note 1: One of the most common symptoms of mesothelioma is a pleural effusion, or an accumulation

of fluid between the parietal pleura (the pleura covering the chest wall and diaphragm) and the visceral

pleura (the pleura covering the lungs). Record the absence or presence of pleural effusion and

specifically, if present, whether the pleural effusion is non-malignant, malignant, atypical or NOS.

Note 2: A physician’s statement of positive (malignant) pleural effusion or a positive cytology confirming

a malignant pleural effusion must be used to code this data item.

Code 2 when

o There is a positive malignant pleural effusion confirmed by cytology

o Pleural fluid cytology is described as suspicious/suspicious for mesothelioma

Code 3 when cytology is described as atypical/atypical mesothelial cells

Note 3: The presence of a pleural effusion on imaging alone (i.e., a pleural effusion, NOS) is not

equivalent to a malignant pleural effusion.

Code 1 if imaging indicates a pleural effusion but pleural cytology is described as negative for

malignant cells

Code 4 if imaging indicates a pleural effusion and there is no further information on whether it is

positive or negative or cytology not done

Code

Description

0 Pleural effusion not identified/not present

1 Pleural effusion present, non-malignant (negative)

Pleural effusion present, malignant (positive)

Physician states pleural effusion is malignant in the absence of positive cytology

3 Pleural effusion, atypical/atypical mesothelial cells

4 Pleural effusion, NOS

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Pleural effusion not assessed or unknown if assessed

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BONE

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00381: Bone Appendicular Skeleton (2018+)

3908: Percent Necrosis Post Neoadjuvant

Item Length: 5

NAACCR Item #: 3908

XML Parent-NAACCR ID: Tumor-percentNecrosisPostNeoadjuvant

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00381: Bone Appendicular Skeleton (2018+)

00382: Bone Spine (2018+)

00383: Bone Pelvis (2018+)

Description

Percent Necrosis Post Neoadjuvant is a prognostic factor for bone sarcomas.

Rationale

Percent Necrosis Post Neoadjuvant is a Registry Data Collection Variable for AJCC. It was previously

collected as Bone, CS SSF #3.

Definition

For osteosarcoma and Ewing’s sarcoma/PNET, response to neoadjuvant chemotherapy is a prognostic

factor. Patients with more than 90% tumor necrosis have a more favorable prognosis than those with

less response. The CAP protocol for bone tumor resection provides the pathologist with specific

instructions for determining the percentage of tumor necrosis. A separate method (system of Picci) may

describe response to treatment in grades: grade I (macroscopic viable tumor), grade II (microscopic

viable tumor), or grade III (no viable tumor). Do not code the Picci grade system in this data item.

Record the percentage value of tumor necrosis post neo-adjuvant chemotherapy as stated by the

pathologist in the pathology report. Code the value to the nearest whole percent in the range 001 to

100. If the patient has no resection or was not treated with pre-operative chemotherapy, code XXX.9

Additional Information

Source documents: pathology report

For further information, refer to the Bone cancer protocol published by the College of American

Pathologists for the AJCC Staging System Bone

Other names: Histologic treatment response, therapy response, chemotherapy effect

Coding instructions and Codes

Note 1: Physician statement of microscopically confirmed Percent Necrosis Post Neoadjuvant

Chemotherapy can be used to code this data item if no other documentation is available

Note 2: Record percentage value of the tumor necrosis post neoadjuvant chemotherapy as recorded in

the pathology report from resection of the primary tumor.

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Note 3: Code XXX.9 if

Surgical resection of the primary site after neoadjuvant therapy is performed and there is no

mention of percent necrosis

Surgical resection of the primary site is the initial therapy; therefore, no neoadjuvant therapy

was performed

Code Description

0.0 Tumor necrosis not identified/not present

0.1-

100.0

0.1 – 100.0 percent tumor necrosis

(Percentage of tumor necrosis to nearest tenth of a percent)

XXX.2 Tumor necrosis present, percent not stated

XXX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XXX.8 will result in an edit error.)

XXX.9 Not documented in medical record

No histologic examined of primary site

No neoadjuvant therapy

No surgical resection of primary site is performed

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00382: Bone Spine (2018+)

See 00381: Bone Appendicular Skeleton (2018+)

3908: Percent Necrosis Post Neoadjuvant

00383: Bone Pelvis (2018+)

See 00381: Bone Appendicular Skeleton (2018+)

3908: Percent Necrosis Post Neoadjuvant

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SOFT TISSUE SARCOMA

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00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

Item Length: 1

NAACCR Item #: 3815

XML Parent-NAACCR ID: Tumor-boneInvasion

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00400: Soft Tissues Head and Neck (2018+)

00410: Soft Tissue Trunk and Extremities (2018+)

00421: Soft Tissues Abdomen and Thoracic (excluding Heart, Mediastinum, Pleura) (2018+)

00422: Heart, Mediastinum, and Pleura (2018+)

00440: Retroperitoneum (2018+)

00450: Soft Tissue Rare (2018+)

00459: Soft Tissue Other (2018+)

Description

Bone invasion, the presence or absence of bone invasion based on imaging, is a prognostic factor for

soft tissue sarcoma.

Rationale

Bone Invasion is a Registry Data Collection Variable in AJCC. This data item was previously collected for

Soft Tissue, SSF #3.

Definition

Direct tumor extension from the primary sarcoma into adjacent bone. This field does not include distant

or discontinuous metastases to the skeletal system. Information in this field is based on radiology and

other imaging techniques.

Coding guidelines

Code 0 when there is no evidence of bone invasion on imaging

Code 1 when there is evidence of bone invasion on imaging

Code 9 when

o No information in the medical record

o Bone invasion not evaluated (assessed)

o Unknown if bone invasion evaluated (assessed)

Additional Information

Source documents: imaging report

Coding Instructions and Codes

Note 1: Physician statement of Bone Invasion can be used to code this data item when no other

information is available.

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Note 2: Record bone invasion as determined by relevant imaging only for the primary tumor. Imaging

methodologies include computed tomography (CT) scans and magnetic resonance imaging (MRI).

Note 3: Code 0 if relevant imaging is performed and there is no mention of bone invasion.

Note 4: Code 9 if there is no relevant imaging of the primary site.

Code Description

0 Bone invasion not present/not identified on imaging

1 Bone invasion present/identified on imaging

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

Bone invasion not assessed or unknown if assessed

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00410: Soft Tissue Trunk and Extremities (2018+)

See 00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

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00410: Soft Tissue Trunk and Extremities (2018+)

3927: Schema Discriminator 2: Soft Tissue Sarcoma (C473, C475, C493-C495)

Item Length: 1

NAACCR Item #: 3927

XML Parent-NAACCR ID: Tumor-schemaDiscriminator2

NAACCR Alternate Name: None

Active years: 2018+

AJCC 8th Edition Chapter(s):

00410: Soft Tissue Trunk and Extremities (2018+)

00421: Soft Tissues Abdomen and Thoracic (excluding Heart, Mediastinum, Pleura) (2018+)

00459: Soft Tissue Other (2018+)

Definition

The ICD-O-3 assigned topography codes for the peripheral nerve and autonomic nervous systems

tumors (C47) and the connective, subcutaneous and other soft tissues (C49) primary sites are based on

transverse or horizontal planes. The AJCC Staging System Soft Tissue Sarcoma of the Trunk and

Extremities, and Soft Tissue Sarcoma of the Abdomen and Thoracic Visceral Organs base the eligible

sites as either external structures or internal viscera. For example

C493 axilla is an external site using the AJCC Staging System Soft Tissue Sarcoma of the Trunk

and Extremities

C493 axillary artery is an internal site using the AJCC Staging System Soft Tissue Sarcoma of the

Abdomen and Thoracic Visceral Organs

C475 sacrococcygeal region is a large area that may be either external or internal

o Need to determine the exact area involved to assign the correct chapter

o C475 external area of sacrococcygeal region uses the AJCC Staging System Soft Tissue

Sarcoma of the Trunk and Extremities

o C475 intrapelvic area of sacrococcygeal region uses the AJCC Staging System Soft Tissue

Sarcoma of the Abdomen and Thoracic Visceral Organs To develop a software algorithm

that can be used to send the registrar to the correct system/schema, this schema

discriminator was developed.

The schema discriminator is based on determining whether the structure involved is part of the external

structures or the internal viscera. This is accomplished by

Terms in ICD-O-3 topography codes sorted appropriately by the physician experts when possible

Instructions on what to do when terms are not specific enough to be assigned as external

structures or internal viscera

o Without additional information, these may not be staged, for example C475 pelvis

o With additional information, these may be determined to be external structures or

internal viscera

In addition to the topography codes and terms, there is also an option of “External sites, NOS”

and “Internal sites, NOS” for registrars to use to assign the schema discriminator. Registrars may

need to use additional information, including physician staging, to choose the appropriate

schema discriminator

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Coding Instructions and Codes

Note 1: A schema discriminator is used to discriminate for peripheral nerve tumors (C473, C475) and

connective tissue tumors (C493, C494, C495) for the subsite in which the tumor arose.

Note 2: Code 1 is used for external structures and is assigned to the AJCC Staging System Soft Tissue

Sarcoma of the Trunk and Extremities (Schema ID 00410: Soft Tissue Sarcoma of the Trunk and

Extremities).

Example: Trapezius muscle (C493) is an external structure, on the outer layer or periphery of the

body

Note 3: Code 2 is used for internal structures and is assigned to the AJCC Staging System Soft Tissue

Sarcoma of the Abdomen and Thoracic Visceral Organs (Schema ID 00421: Soft Tissue Sarcoma of the

Abdomen and Thoracic Visceral Organs).

Example: Aorta (C493) is an internal structure, in the inner parts of the body

Note 4: Code 8 is only used for cases for 2018-2020 that have already been abstracted prior to the

Version 2.0 update (2021 update). It can also be used for 2018-2020 cases that are abstracted after the

2021 updates.

For cases diagnosed 2021+, code 8 cannot be used

Note 5: Code 9 is used for when there is not enough specific information to determine if the structure is

external or internal. These cases are collected in Schema ID 00459: Soft Tissue Other.

Example: Chest NOS (C493) does not provide enough information in order to determine if it is

either an external structure, on the outer layer or periphery of the body, or an internal

structure, in the inner parts of the body

Code Description Schema ID#/Description

1 External structures (sites), NOS

Examples of terms include:

Peripheral nerves and autonomic nervous system (C47)

Pelvis (C475)

o Buttock

o Gluteal region

o Groin

o Inguinal region

o Perineum

o Sacrococcygeal region (stated as

external)

Thorax (C473)

o Axilla

o Chest wall

o Infraclavicular region

o Scapular region

o Thoracic wall

Connective, subcutaneous and other soft tissues (C49)

00410: Soft Tissue Trunk and

Extremities

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Code Description Schema ID#/Description

Abdomen (C494)

o Abdominal wall

o Abdominal wall muscle

o Iliopsoas muscle

o Psoas muscle

o Rectus abdominis muscle

o Umbilicus

Pelvis (C495)

o Buttock

o Gluteal region

o Gluteus maximus muscle

o Groin

o Inguinal region

o Perineum

o Sacrococcygeal region

Thorax (C493)

o Axilla

o Chest wall

o Infraclavicular region

o Intracostal muscle

o Latissimus dorsi muscle

o Pectoralis major muscle

o Scapular region

o Thoracic wall

Trapezius muscle

2 Internal structures and viscera (sites), NOS

Examples of terms include

Peripheral nerves and autonomic nervous system (C47)

Sacrococcygeal region (intrapelvic)

Connective, subcutaneous and other soft tissues (C49)

Abdomen (C494)

o Abdominal aorta

o Abdominal vena cava

o Celiac artery

o Inferior vena cava

o Mesenteric artery

o Renal artery

o Vena cava

Pelvis (C495)

o Iliac artery

o Iliac vein

Thorax (C493)

o Aorta

o Axillary artery

o Diaphragm

o Internal mammary artery

Subclavian artery

00421: Soft Tissue Abdomen

and Thoracic (excluding Heart,

Mediastinum, Pleura)

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Code Description Schema ID#/Description

o Superior vena cava

Thoracic duct

8 Not applicable: Diagnosis date 2018-2020 00421: Soft Tissue Abdomen

and Thoracic (excluding Heart,

Mediastinum, Pleura)

9 Not specific enough to determine if external or internal

Examples of terms include

Peripheral nerves and autonomic nervous system (C47)

Pelvis (C475)

o Lumbosacral plexus

o Sacral nerve

o Sacral plexus

Thorax (C473)

o Chest

o Intercostal nerve

Connective, subcutaneous and other soft tissues (C49)

Thorax (C493)

o Chest, NOS

Thorax

00459: Soft Tissue Other

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00421: Soft Tissue Abdomen and Thoracic (2018+)

See 00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

See 00410: Soft Tissue Trunk and Extremities (2018+)

3927: Schema Discriminator 2: Soft Tissue Sarcoma (C473, C475, C493-C495)

00422: Heart, Mediastinum and Pleura (2018+)

See 00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

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00430: GIST (2018+)

3926: Schema Discriminator 1: Primary Peritoneum Tumor

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00430: GIST (2018+)

Definition

The GIST chapter includes a schema discriminator for C481 for location of the primary tumor because all

the peritoneum structures are coded to C481, but two separate stage tables are used to derive the TNM

values.

Coding Instructions and Codes

Note: Since both omental and peritoneal gastrointestinal stromal tumors (GIST) are coded with the

same ICD-O-3 topography code (C481), this data item must be used to identify the appropriate AJCC

stage table.

Code Description Stage Table

Mesentery

Mesoappendix

Mesocolon

Pelvic peritoneum

Rectouterine pouch

Cul de sac

Pouch of Douglas

Other specified peritoneal site

Small Intestinal, Esophageal,

Colorectal, Mesenteric and

Peritoneal GIST

Omentum

Gastric and Omental GIST

Unknown or no information

Not documented in medical record

Small Intestinal, Esophageal,

Colorectal, Mesenteric and

Peritoneal GIST

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00430: GIST (2018+)

3865: KIT Gene Immunohistochemistry

Item Length: 1

NAACCR Item #: 3865

XML Parent-NAACCR ID: Tumor-kitGeneImmunohistochemistry

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00430: GIST (2018+)

Description

KIT Gene Immunohistochemistry (IHC) is the expression of the KIT gene in tumor tissue specimens based

on immunohistochemical (IHC) stains. A positive test is a diagnostic and predictive marker for GIST

tumors.

Rationale

KIT Gene Immunohistochemistry (IHC) is a Registry Data Collection Variable in AJCC. This data item was

previously collected for GIST schemas in CS (different SSFs).

Definition

KIT is a gene that regulates cell growth and differentiation. Mutations of this gene become oncogenes

and cause a gastrointestinal stromal tumor to ignore cellular control signals. About 85-90% of GIST

tumors contain oncogenic mutations of the KIT receptor gene. KIT immunohistochemistry is a special

immunofluorescent stain that turns mutated cells brown and confirms a diagnosis of GIST. The presence

of the KIT gene also indicates that the patient may respond to Gleevec or Sutent.

Additional Information

Source documents: pathology report (special stain)

Other names: CD117, c-kit receptor, KIT receptor tyrosine kinase, or SCFR (stem cell factor

receptor)

Coding Instructions and Codes

Note 1: Physician statement of KIT IHC can be used to code this data item when no other information is

available.

Note 2: KIT Gene Immunohistochemistry (IHC) is the expression of the KIT gene in tumor tissue

specimens based on immunohistochemical (IHC) stains. A positive test is a diagnostic and predictive

marker for GIST tumors. Do not record secondary or acquired mutations that may have developed

because of long-term imatinib treatment.

Note 3: Other names for KIT are CD117 or c-kit.

Note 4: Results from nodal or metastatic tissue may be used for KIT Gene Immunohistochemistry.

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Code Description

0 KIT negative/normal; within normal limits

1 KIT positive

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

Cannot be determined by pathologist

KIT not assessed or unknown if assessed

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00440: Retroperitoneum (2018+)

See 00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

00458: Soft Tissue Rare (2018+)

See 00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

00459: Soft Tissue Other (2018+)

See 00400: Soft Tissue Head and Neck (2018+)

3815: Bone Invasion

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck (2018+)

3926: Schema Discriminator 1: Occult Head and Neck Lymph Nodes

See 00410: Soft Tissue Trunk and Extremities (2018+)

3927: Schema Discriminator 2: Soft Tissue Sarcoma (C473, C475, C493-C495)

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SKIN

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00460: Merkel Cell Carcinoma (2018+)

3830: Extranodal Extension Clin (non-Head and Neck)

Item Length: 1

NAACCR Item #: 3830

XML Parent-NAACCR ID: Tumor-extranodalExtensionClin

NAACCR Alternate Name: Extranodal Extension Clinical (non-Head and Neck)

Active years: 2018+

Schemas(s):

00460: Merkel Cell Skin (2018+)

00570: Penis (2018+)

Description

Extranodal Extension (ENE) Clinical is defined as “the extension of a nodal metastasis through the lymph

node capsule into adjacent tissue” during the diagnostic workup. This data item defines clinical ENE for

sites other than Head and Neck.

Rationale

Extranodal Extension Clinical (non-Head and Neck) is a Registry Data Collection Variable for AJCC. This

data item was previously collected for Penis, SSF #17.

Definition

The presence of extranodal extension (ENE) from regional lymph nodes is an important prognostic factor

in some cancers because these patients are rarely cured without some type of systemic chemotherapy

or radiation. Extranodal extension is defined as metastatic tumor growing from within the lymph node

outward through the lymph node capsule and into surrounding connective tissues.

This data item is for ENE that is detected clinically.

Coding guidelines

Code 0 when there are positive nodes clinically, but ENE not identified/not present.

Code 1 when there are positive nodes clinically, ENE is identified by physical exam WITH or

WITHOUT imaging

Code 2 when there are positive nodes clinically, ENE is identified by biopsy (microscopically

confirmed)

Code 7 when nodes are clinically negative (cN0)

Code 4 when there are positive nodes clinically, ENE is identified, but not known how identified

Code 9 when

o No information in the medical record

o Positive nodes clinically, not evaluated (assessed) for ENE

o Positive nodes clinically, unknown if evaluated (assessed) for ENE

o Lymph nodes not evaluated (assessed) clinically

o Unknown if lymph nodes evaluated (assessed) clinically

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Additional Information

Source documents: pathology report, imaging reports, physical exam

Other names: ENE, extracapsular extension, ECE

Coding Instructions and Codes

Note 1: Physician statement of Extranodal Extension (ENE) Clinical or physician clinical staging can be

used to code this data item when there is no other information available.

Note 2: Extranodal Extension Clinical is defined as “the extension of a nodal metastasis through the

lymph node capsule into adjacent tissue” identified during the diagnostic workup. ENE is the preferred

terminology. Other names include: extranodal spread, extracapsular extension, or extracapsular

spread.”

Note 3: Be aware that the rules for coding ENE for head and neck sites compared to non-head and neck

sites are different.

Note 4: Code the status of extranodal extension assessed during the diagnostic workup for the

assignment of the clinical stage for the most involved regional lymph node(s). This is mainly determined

by physical examination and includes statements such as fixed or matted nodes. Imaging may also be

used, as well as lymph node biopsies or sentinel node biopsies performed prior to any treatment. Do not

code ENE for any distant nodes.

Code Description

0 Regional lymph nodes involved, ENE not present/not identified during diagnostic workup

1 Regional lymph nodes involved, ENE present/identified during diagnostic workup, based on

physical exam WITH or WITHOUT imaging

2 Regional lymph nodes involved, ENE present/identified during diagnostic workup, based on

microscopic confirmation

4 Regional lymph nodes involved, ENE present/identified, unknown how identified

No lymph node involvement during diagnostic workup (cN0)

Non-invasive neoplasm (behavior /2)

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error)

9 Not documented in medical record

Clinical ENE not assessed or unknown if assessed during diagnostic workup

Clinical assessment of lymph nodes not done, or unknown if done

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00460: Merkel Cell Carcinoma (2018+)

3833: Extranodal Extension Path (non-Head and Neck)

Item Length: 1

NAACCR Item #: 3833

XML Parent-NAACCR ID: Tumor-extranodalExtensionPath

NAACCR Alternate Name: Extranodal Extension Pathological (non-Head and Neck)

Active years: 2018+

Schemas(s):

00460: Merkel Cell Skin (2018+)

00570: Penis (2018+)

Description

Extranodal Extension (ENE) Pathological is defined as “the extension of a nodal metastasis through the

lymph node capsule into adjacent tissue. This data item defines pathological ENE for sites other than

Head and Neck.

Rationale

Extranodal Extension Pathological (non-Head and Neck) is a Registry Data Collection Variable for AJCC.

This data item was previously collected for Penis, SSF #17.

Definition

The presence of extranodal extension (ENE) from regional lymph nodes is an important prognostic factor

in some cancers because these patients are rarely cured without some type of systemic chemotherapy

or radiation. Extranodal extension is defined as metastatic tumor growing from within the lymph node

outward through the lymph node capsule and into surrounding connective tissues.

This data item is for ENE that is detected pathologically.

Coding guidelines

Code 0 when there are positive nodes pathologically, but ENE not identified/not present

Code 1 when there are positive nodes pathologically, ENE is identified

Code 7 when nodes are surgically resected, and they are negative (pN0)

Code 9 when

o No information in the medical record

o Positive nodes pathologically, not evaluated (assessed) for ENE

o Positive nodes pathologically, unknown if evaluated (assessed) for ENE

o Lymph nodes not evaluated (assessed) pathologically (no surgical resection of lymph

nodes)

o Unknown if lymph nodes evaluated pathologically (assessed)

Additional Information

Source documents: pathology report from surgical resection

Other names: ENE, extracapsular extension, ECE

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Coding Instructions and Codes

Note 1: Physician statement of Extranodal Extension (ENE) Pathological or physician pathological staging

can be used to code this data item when there is no other information available.

Note 2: Extranodal extension is defined as "the extension of a nodal metastasis through the lymph node

capsule into adjacent tissue." ENE is the preferred terminology. Other names include: extranodal spread,

extracapsular extension, or extracapsular spread."

"A regional node extending into a distant structure or organ is categorized as ENE and is not

recorded as distant metastatic disease."

Note 3: Be aware that the rules for coding ENE for head and neck sites compared to non-head and neck

sites are different.

Note 4: Code the status of extranodal extension assessed on the surgical resection specimen for the

most involved regional lymph node(s). Do not code ENE for any distant lymph nodes. Code the status of

ENE based on the following criteria

Code 0

o Absence of ENE, positive lymph nodes assessed by lymph node dissection

o 1292: Scope of Regional Lymph Node Surgery must be 3-7

Code 1

o Presence of ENE assessed by Sentinel Lymph Node biopsy

o Presence of ENE assessed by lymph node dissection

o 1292: Scope of Regional Lymph Node Surgery must be 2-7

Code 7

o Lymph nodes negative for cancer assessed by Sentinel lymph node biopsy or lymph

node dissection

o 1292: Scope of Regional Lymph Node Surgery must be 2-7

Code 9

o Absence of ENE, positive lymph nodes assessed by Sentinel Lymph Node biopsy

A positive Sentinel Lymph Node biopsy cannot assess the absence of ENE, only

the presence of it. This is because there is not enough surrounding tissue in a

Sentinel Lymph node biopsy to accurately assess ENE

If codes 1 or 7 are used, this indicates that the lymph nodes were surgically resected or a

Sentinel Lymph Node biopsy was done and Scope of Regional Lymph Node Surgery [NAACCR

Data Item: 1292] must be 2-7

Code Description

0 Regional lymph nodes involved, ENE not present/not identified from surgical resection

1 Regional lymph nodes involved, ENE present/identified from surgical resection

7 No lymph node involvement from surgical resection (pN0)

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error)

9 Not documented in medical record

No surgical resection of regional lymph nodes

Non-invasive neoplasm (behavior /2)

Cannot be determined

Pathological assessment of lymph nodes not done, or unknown if done

Extranodal Extension Pathological not assessed or unknown if assessed

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00460: Merkel Cell Carcinoma (2018+)

3880: LN Isolated Tumor Cells (ITC)

NAACCR Item #: 3880

XML Parent-NAACCR ID: Tumor-lnIsolatedTumorCells

NAACCR Alternate Name: Lymph Nodes Isolated Tumor Cells (ITC)

Active years: 2018+

Schemas(s):

00460: Merkel Cell Skin (2018+)

Description

Lymph Nodes Isolated Tumor Cells (ITC), the presence of isolated tumor cells in regional lymph node(s)

that may be detected by hematoxylin and eosin or by immunohistochemical staining, is a potential

prognostic factor for Merkel Cell Carcinoma.

Rationale

Lymph Nodes, Isolated Tumor Cells (ITC) is a Registry Data Collection Variable in AJCC. This data item

was previously collected for Merkel Cell Skin, SSF #18.

Definition

Isolated tumor cells (ITCs) for Merkel cell carcinoma are defined as single tumor cells or small clusters of

tumor cells not more than 0.2 mm in greatest dimension. ITCs are usually detected by

immunohistochemistry on sentinel lymph node biopsies.

Note: Examples of immunohistochemical staining methods are Cytokeratin 20 (CK20), CAM 5.2,

pancytokeratin, and AE1/3. ITCs may be detected by routine H&E stains.

Additional information

Source documents: pathology report

Coding Instructions and Codes

Note 1: Physician statement of Isolated Tumor Cells (ITCs) can be used to code this data item when no

other information is available.

Note 2: ITCs include single tumor cells or small clusters, less than or equal to 0.2 mm in greatest

dimension, generally without stromal response in the lymph node. These cells usually are found in the

subcapsular nodal sinuses but may be seen within the nodal parenchyma.

Note 3: ITCs may be identified in lymph nodes by hematoxylin and eosin staining or by specialized

pathological techniques, such as IHC for cytokeratin proteins for carcinomas. Specialized pathology

techniques such IHC and molecular techniques are not recommended for routine examination of lymph

nodes.

Note 4: Record the status of ITCs as documented by the pathologist.

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Code Description

0 Regional lymph nodes negative for ITCs

Regional lymph nodes positive for ITCs

(Tumor cell clusters not greater than 0.2 millimeter (mm))

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

Cannot be determined by pathologist

ITCs not assessed or unknown if assessed

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00460: Merkel Cell Carcinoma (2018+)

3918: Profound Immune Suppression

Item Length: 1

NAACCR Item #: 3918

XML Parent-NAACCR ID: Tumor-profoundImmuneSuppression

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00460: Merkel Cell Skin (2018+)

Description

Profound Immune Suppression, suppressed immune status that may be associated with HIV/AIDs, solid

organ transplant, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple conditions or other

conditions, increases the risk of developing Merkel Cell Carcinoma and is an adverse prognostic factor.

Rationale

Profound Immune Suppression is a Registry Data Collection Variable in AJCC. It was previously collected

as Merkel Cell Penis, SSF #22, Merkel Cell Scrotum SSF #22, Merkel Cell Skin, SSF #22, and Merkel Cell

Vulva, SSF #22.

Definition

Profound immune suppression may greatly increase the risk of developing Merkel cell carcinoma.

Immune suppression is suppression of the body's immune system and its ability to fight infections and

other diseases. Immune suppression may be deliberately induced with drugs, as in preparation for bone

marrow or other organ transplantation, to prevent rejection of the donor tissue. It may also result from

certain diseases such as Acquired Immune Deficiency Syndrome (AIDS) or lymphoma, and from the use

of anti-cancer drugs.

Additional Information

Source documents: patient history, consultation notes, other statement in medical record

Other names: immunosuppression

Coding Instructions and Codes

Note 1: Physician statement of Profound Immune Suppression must be used to code this data item. Do

not assume that a patient is immune suppressed just because the patient has one of the conditions

listed below in the table. Per AJCC experts, the following terms can also be used to describe “profound

immune suppression.”

Immunocompromised

Immunosuppressed

Suppressed immune status

Note 2: Per AJCC experts, this data item is limited to the conditions in the table below occurring within

two years of the diagnosis of Merkel cell carcinoma.

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For the following conditions, these patients will experience chonic immunosuppression. These

are no time limits for these conditions. If a patient has a history (regardless of when diagnosed

or treatment status), code as present

o Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS)

(Code 1)

o Solid organ transplant recipient (Code 2)

o Chronic lymphocytic leukemia (Code 3)

Note 3: Code 9 if conditions in the table below were not active within 2 years of (or resolved more than

2 years prior to) diagnosis, or if it is unknown when they existed.

Note 4: If more than one condition is documented, code 5. Document the specific conditions in the text

field.

Code Description

0 No immune suppression condition(s) identified/not present

1 Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS)

2 Solid organ transplant recipient

3 Chronic lymphocytic leukemia

4 Non-Hodgkin lymphoma

5 Multiple immune suppression conditions

Profound immune suppression present

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

Not documented in medical record

Profound immune suppression not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3817: Breslow Tumor Thickness

Item Length: 4

NAACCR Item #: 3817

XML Parent-NAACCR ID: Tumor-breslowTumorThickness

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00470: Melanoma Skin (2018+)

Description

Breslow Tumor Thickness, the measurement of the thickness of a melanoma as defined by Dr. Alexander

Breslow, is a prognostic factor for Melanoma of the Skin

Rationale

Breslow Tumor Thickness is a Registry Data Collection Variable in AJCC. It was previously collected as

Melanoma Skin, CS SSF #1.

Definition

A measure of how deeply a melanoma tumor has grown into the skin. The tumor thickness (depth) is

usually measured from the top of the tumor to the deepest tumor cells. If the tumor is ulcerated (the

skin is broken), it is measured from the base of the ulcer to the deepest tumor cells. Breslow thickness is

used to help determine the stage of cancer. Thicker tumors are linked with lower survival rates.

Coding guidelines

Code a measurement specifically labeled as “thickness” or “depth” or “Breslow depth of invasion” from

the pathology report. In the absence of this label, a measurement described as taken from the cut

surface of the specimen may be coded. And in the absence of either of these labels, the third dimension

in a statement of tumor size can be used to code this field.

Code the greatest measured thickness from any procedure performed on the lesion, whether it is

described as a biopsy or an excision. Do not add measurements together from different procedures.

Example: A punch biopsy with a thickness of 0.5 mm is followed by a re-excision with a thickness

of residual tumor of 0.2 mm. Code 0.5 mm.

If the tumor is excised post-neoadjuvant treatment, tumor measurements cannot be compared before

and after treatment to determine which would indicate the greater involvement. The same code (XX.9)

is used for cases with no surgical procedure of the primary site and cases with surgical procedure of the

primary site after neoadjuvant treatment.

Because the thickness table is similar to many other tables that collect a measurement, it is important to

identify the correct unit of measurement.

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In the range 0.1-99.9, code the actual tumor thickness, tumor depth, or Breslow measurement in tenths

of millimeters as stated in the pathology report. If the measurement is given in hundredths of

millimeters, use the general rules for rounding to determine the value in tenths of millimeters. This is a

four-digit field with a decimal point in the third digit.

Examples: Tumor described as 0.5 mm in depth – code as 0.5. Lesion 1 mm thick – code as

1.0. Breslow 2.5 mm – code as 2.5. Thickness of 10 mm (1 cm) – code as 10.0).

Additional Information

Source documents: pathology report

For further information, refer to the Skin Melanoma cancer protocol published by the College of

American Pathologists for the AJCC Staging System Melanoma of the Skin

Other names: maximum tumor thickness, Breslow depth of invasion, Breslow thickness, Breslow

measurement, Breslow’s microstaging

Coding Instructions and Codes

Note 1: Physician statement of Breslow Tumor Thickness can be used to code this data item when no

other information is available, or the available information is ambiguous.

Note 2: Code Breslow tumor thickness, not size. Record actual measurement in tenths of millimeters

from the pathology report. Measurement given in hundredths of millimeters should be rounded to the

nearest tenth.

Examples:

0.4 mm – 0.4

1.0 mm- 1.0

2.5 mm – 2.5

2.56 mm- 2.6

11 mm – 11.0

12.35 mm – 12.4 mm

Note 3: Code the greatest measured thickness from any procedure performed on the lesion, whether it

is described as a biopsy or an excision.

For example, if a punch biopsy with a thickness of 1.5 mm is followed by a re-excision with a

thickness of residual tumor of 0.2 mm, code 1.5.

Note 4: If there are multiple procedures and the pathologist adds the measurement together to get a

final Breslow’s depth, the registrar can use this.

Do not add the measurements together, only the pathologist can do this

Note 5: If the pathologist describes the thickness as “at least,” use the appropriate A code. An exact

measurement takes precedence over A codes.

If the pathologist states “greater than” instead of “at least”, code to XX.9, unless it is greater

than 9.9 mm (Code AX.0)

Examples:

Pathologist states the thickness is “at least 2.0 mm.” Code A2.0

Pathologist states the thickness is “greater than 4 mm.” Code XX.9

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Code Description

0.0 No mass/tumor found

0.1 Greater than 0.0 and less than or equal to 0.1

0.2-99.9 0.2 – 99.9 millimeters

XX.1 100 millimeters or larger

A0.1

A9.9

Stated as “at least” some measured value of 0.1 to 9.9

AX.0 Stated as greater than 9.9 mm

XX.8

Not applicable: Information not collected for this schema

(If this item is required by your standard setter, use of code XX.8 will result in an edit error)

XX.9 Not documented in medical record

Microinvasion; microscopic focus or foci only and no depth given

Cannot be determined by pathologist

Non-invasive neoplasm (behavior /2)

Breslow Tumor Thickness not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3936: Ulceration

Item Length: 1

NAACCR Item #: 3936

XML Parent-NAACCR ID: Tumor-ulceration

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00470: Melanoma Skin (2018+)

Description

Ulceration, the absence of an intact epidermis overlying the primary melanoma based upon

histopathological examination, is a prognostic factor for melanoma of the skin.

Rationale

Ulceration is a Registry Data Collection Variable in AJCC. It was previously collected as Melanoma Skin,

CS SSF #2.

Definition

Ulceration is the formation of a break on the skin or on the surface of an organ. An ulcer forms when the

surface cells die and are cast off. Ulcers may be associated with cancer and other diseases.

Primary tumor ulceration has been shown to be a dominant independent prognostic factor, and if

present, changes the pT stage from T1a to T1b, T2a to T2b, etc., depending on the thickness of the

tumor.

The presence or absence of ulceration must be confirmed on microscopic examination. Melanoma

ulceration is defined as the combination of the following features

Full-thickness epidermal defect (including absence of stratum corneum and basement

membrane)

Evidence of reactive changes (i.e., fibrin deposition, neutrophils); and thinning, effacement, or

reactive hyperplasia of the surrounding epidermis in the absence of trauma or a recent surgical

procedure

Ulcerated melanomas typically show invasion through the epidermis, whereas nonulcerated

melanomas tend to lift the overlying epidermis

Coding guidelines

Record whether ulceration is present or absent

Code 0 when there is a statement in the pathology report that no ulceration is present

Code 1 when the pathologist states that ulceration is present

Code 9 when

o No information in the medical record

o Pathology report is not available

o Ulceration not evaluated (not assessed)

o Unknown if Ulceration evaluated (assessed)

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Additional Information

Source documents pathology report, physical exam, consultant notes, other statement in

medical record

For further information, refer to the Skin Melanoma cancer protocol published by the College of

American Pathologists for the AJCC Staging System Melanoma of the Skin

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of ulceration, the registrar could assume that it was negative and code

appropriately. For the SSDI, this assumption cannot be made. There must be a statement that

ulceration is not present to code 0

Coding Instructions and Codes

Note 1: Physician statement of microscopically confirmed ulceration (e.g., based on biopsy or surgical

resection) can be used to code this data item.

Note 2: Ulceration can only be confirmed by microscopic examination. Do not use findings from physical

exam.

It is possible for a patient to present with an ulcerated lesion noted on physical exam, but this is

not the same thing as ulceration seen on a microscopic exam

Note 3: Melanoma ulceration is the absence of an intact epidermis overlying the primary melanoma

based upon histopathological examination.

Code 1 if any biopsy (punch, shave, excisional, etc.) or wide excision is positive for ulceration in

the presence of an underlying melanoma

Code 0 is all specimens are negative OR one specimen is negative and the other is unknown

Ulceration must be caused by an underlying melanoma. Ulceration caused by trauma from a

previous procedure should not be coded as positive for this SSDI

Note 4: Code 9 if there is microscopic examination and there is no mention of ulceration.

This instruction does apply to non-invasive neoplasms (behavior 2)

Code

Description

0 Ulceration not identified/not present

1 Ulceration present

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Cannot be determined by the pathologist

Pathology report does not mention ulceration

Ulceration not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3893: Mitotic Rate Melanoma

Item Length: 2

NAACCR Item #: 3893

XML Parent-NAACCR ID: Tumor-mitoticRateMelanoma

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00470: Melanoma Skin (2018+)

Description

Mitotic Rate Melanoma, the number of mitoses per square millimeter based on pathological evaluation,

is a prognostic factor for melanoma of the skin.

Rationale

Mitotic Rate Melanoma is a Registry Data Collection Variable in AJCC. It was previously collected as

Melanoma Skin, CS SSF #7.

Definition

Mitotic count is a way of describing the potential aggressiveness of a tumor. Record the number of cells

actively dividing as determined by the pathologist. The count will vary according to the type of tumor.

Additional Information

Source documents: pathology report

For further information, refer to the Skin Melanoma cancer protocol published by the College of

American Pathologists for the AJCC Staging System Melanoma of the Skin

Other names: mitotic rate, mitotic index (a ratio—do not record this measurement), mitotic

activity

Coding Instructions and Codes

Note 1: Physician statement of the Mitotic Rate Melanoma can be used to code this data item when no

other information is available.

Note 2: The term “mitotic figures” is the same as mitoses.

Note 3: Record the mitotic rate/count as documented in the pathology report. If there is more than one

pathology report for the same melanoma at initial diagnosis and different mitotic counts are

documented, code the highest mitotic count from any of the pathology reports.

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Code Description

00 0 mitoses per square millimeter (mm)

Mitoses absent

No mitoses present

01-99 1 - 99 mitoses/square mm

(Exact measurement in mitoses/square mm)

X1 100 mitoses/square mm or more

X2 Stated as "less than 1 mitosis/square mm"

Stated as "nonmitogenic"

X3 Stated as "at least 1 mitosis/square mm"

Stated as "mitogenic"

X4 Mitotic rate described with denominator other than square millimeter (mm)

X7 Test ordered, results not in chart

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit error.)

X9 Not documented in medical record

Mitotic Rate Melanoma not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3932: LDH Lab Value

Item Length: 7

NAACCR Item #: 3932

XML Parent-NAACCR ID: Tumor-ldhPretreatmentLabValue

NAACCR Alternate Name: LDH (Lactate Dehydrogenase) Lab Value, LDH (Lactate Dehydrogenase) Lab

Value

Active years: 2018+

Schemas(s):

00470: Melanoma Skin (2018+)

Description

LDH (Lactate Dehydrogenase) Lab Value, measured in serum, is a predictor of treatment response,

progression-free survival and overall survival for patients with Stage IV melanoma of the skin.

Rationale

LDH Lab Value is a Registry Data Collection Variable in AJCC. It was previously collected as Melanoma

Skin, CS SSF #5.

Definition

When cells (normal or tumor) are damaged or destroyed, an enzyme called lactate dehydrogenase (LDH)

is released into the bloodstream. LDH is an indirect indication of possible tumor burden or damage to

an organ, which may be caused by metastatic involvement of liver or lung, or a myocardial

infarction. The total LDH should be the test value that is coded, but there are five fractions of LDH that

measure tissue specific cellular damage: LD1 and LD2: heart, red blood cells and kidneys; LD3: lung; LD4

and LD5: liver, skin and skeletal muscles. LDH is elevated in 60% of patients with non-seminomatous

germ cell tumors of the testis. LDH is not a screening test, nor is it diagnostic of melanoma, ocular

adnexal lymphoma, or testicular cancer.

Coding guidelines

Code 0.0 for a test result of 0 (U/L).

Code the highest exact LDH lab value prior to systemic (chemo, immunotherapy, hormone),

radiation therapy or surgery to a metastatic site in the range 0.1 to 99,999.9

Code XXXXX.1 for a total LDH lab value of 100,000 or greater.

Code XXXXX.7 if the test was ordered and the results are not in the medical record.

Code XXXXX.9 when

o there is no information in the medical record about the LDH lab value

o Test is not done or unknown if the test was done

Additional Information

Source documents: clinical laboratory report; may be included in a liver or hepatic panel/profile,

a cardiac panel, or a general metabolic panel of tests

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Other names: LDH, Lactate dehydrogenase, lactase dehydrogenase, lactic acid dehydrogenase

Coding Instructions and Codes

Note 1: Physician statement of LDH (Lactate Dehydrogenase) Lab Value can be used to code this data

item when no other information is available.

Note 2: LDH is important in melanoma staging in the setting of DISTANT metastasis. LDH level might

only be ordered after re-excision/wide excision and/or nodal evaluation indicates a higher risk of distant

metastasis. Imaging may then be performed and if distant metastasis are identified, LDH is ordered.

Note 3: Record the lab value of the highest serum LDH test results documented in the medical record

either before or after surgical resection of the primary tumor with or without regional lymph node

dissection. The LDH must be taken prior to systemic (chemo, immunotherapy, hormone), radiation

therapy or surgery to a metastatic site. The lab value may be recorded in a lab report, history and

physical, or clinical statement in the pathology report.

Note 4: The same laboratory test should be used to record information in 3869: LDH Level and 3870:

LDH Upper Limits of Normal.

Code

Description

0.0 0.0 (U/L)

0.1

99999.9

0.1

–

99,999.9 U/L

XXXXX.1 100,000 U/L or greater

XXXXX.7 Test ordered, results not in chart

XXXXX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XXXXX.8 will result in an edit error.)

XXXXX.9 Not documented in medical record

LDH (Lactate Dehydrogenase) Lab Value not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3869: LDH Level

Item Length: 1

NAACCR Item #: 3869

XML Parent-NAACCR ID: Tumor-ldhPretreatmentLevel

NAACCR Alternate Name: LDH (Lactate Dehydrogenase) Level, LDH (Lactate Dehydrogenase) Level

Active years: 2018+

Schemas(s):

00470: Melanoma Skin (2018+)

00821: Plasma Cell Myeloma (2018+)

Description

LDH (Lactate Dehydrogenase) is an enzyme involved in conversion of sugars to energy and present in

most cells in the body. Elevated LDH is an adverse prognostic factor for plasma cell myeloma and

melanoma of the skin.

Rationale

LDH (Lactate Dehydrogenase) Level is a prognostic factor required in AJCC 8

edition for Chapter 82

Plasma Cell Myeloma and Plasma Cell Disorders and Chapter 47 Melanoma Skin. For Plasma Cell

Myeloma, LDH is part of the RISS Stage and is new for cases diagnosed 1/1/2018+. For Melanoma Skin,

LDH is used to define the M subcategories and was previously collected as Melanoma Skin, SSF #4.

Coding Instructions and Codes

Note 1: Use the reference ranges from your lab to determine if LDH is normal.

Note 2: Record the lab value of the highest serum LDH test results documented in the medical record

either before or after surgical resection of the primary tumor with or without regional lymph node

dissection. The LDH must be taken prior to systemic (chemo, immunotherapy, hormone), radiation

therapy or surgery to a metastatic site. The lab value may be recorded in a lab report, history and

physical, or clinical statement in the pathology report.

Note 3: If there is no mention of the LDH, code 9.

Note 4: The same laboratory test should be used to record information in 3870: LDH Upper Limits of

Normal and 3932: LDH Lab Value.

Code Description

Normal LDH level

Low, below normal

1 Above normal LDH level; High

7 Test ordered, results not in chart

9 Not documented in medical record

LDH (Lactate Dehydrogenase) Level not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3870: LDH Upper Limits of Normal

NAACCR Item #: 3870

XML Parent-NAACCR ID: Tumor-ldhUpperLimitsOfNormal

NAACCR Alternate Name: LDH (Lactate Dehydrogenase) Upper Limits of Normal

Active years: 2018+

Schemas(s):

00470: Melanoma Skin (2018+)

Description

LDH (Lactate Dehydrogenase), an enzyme involved in converting sugars to energy in the body, is

elevated in some malignancies. LDH level is a prognostic factor for patients with Stage IV melanoma.

This data Item refers to the Upper Limit of Normal in the laboratory test used to interpret the Serum

LDH result.

Rationale

LDH (Lactate Dehydrogenase) Upper Limits of Normal is a Registry Data Collection Variable in AJCC. It

was previously collected as Melanoma Skin, CS SSF #6.

Definition

When cells (normal or tumor) are damaged or destroyed, an enzyme called lactate dehydrogenase (LDH)

is released into the bloodstream. LDH is an indirect indication of possible tumor burden or damage to

an organ, which may be caused by metastatic involvement of liver or lung, or a myocardial

infarction. The total LDH should be the test value that is coded, but there are five fractions of LDH that

measure tissue specific cellular damage: LD1 and LD2: heart, red blood cells and kidneys; LD3: lung; LD4

and LD5: liver, skin and skeletal muscles. LDH is elevated in 60% of patients with non-seminomatous

germ cell tumors of the testis. LDH is not a screening test, nor is it diagnostic of melanoma, ocular

adnexal lymphoma, or testicular cancer.

Additional Information

Source documents: clinical laboratory report; may be included in a liver or hepatic panel/profile,

a cardiac panel, or a general metabolic panel of tests

Other names: LDH, Lactate dehydrogenase, lactase dehydrogenase, lactic acid dehydrogenase

Normal reference range: varies widely by laboratory, patient age, and the units of

measurement.

Examples of reference range lab values:

o Lab A Total LDH 71 – 207 U/L

o Lab B Total LDH 300 – 600 U/L

o Lab C Total LDH 45 – 90 U/L

o Lab D Total LDH 150 – 250 U/L

Coding Instructions and Codes

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Note 1: Physician statement of LDH (Lactate Dehydrogenase) Upper Limit of Normal can be used to code

this data item.

Note 2: Record the value of the highest serum LDH test results documented in the medical record either

before or after surgical resection of the primary tumor with or without regional lymph node dissection.

The LDH must be taken prior to systemic (chemo, immunotherapy, hormone), radiation therapy or

surgery to a metastatic site. The lab value may be recorded in a lab report, history and physical, or

clinical statement in the pathology report.

Note 3: Upper limits of normal for LDH vary widely depending on the lab. Common upper limits can be

200, 250, 618, or other values.

Note 4: The same laboratory test should be used to record information in 3932: LDH Lab Value and

3869: LDH Level.

Code Description

001-

999

001 - 999 upper limit of normal

(Exact upper limit of normal)

XX8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XX8 may result in an edit error.)

XX9 Not documented in medical record

LDH Upper Limit not assessed or unknown if assessed

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00470: Melanoma Skin (2018+)

3961: Clinical Margin Width

Item Length: 4

NAACCR Item #: 3961

XML Parent-NAACCR ID: clinicalMarginWidth

NAACCR Alternate Name: None

Active years: 2023+

Schemas(s):

00470: Melanoma Skin (2018+)

Description

Clinical margin width describes the margins from a wide excision for a melanoma primary. The margin

width is measured by the surgeon prior to the procedure. The measurement is taken, in centimeters,

from the edge of the lesion or the prior excision scar to the peripheral margin of the specimen.

Rationale

Clinical margin width for wide local excision of a melanoma is based on the original Breslow thickness of

the primary tumor, as indicated on the initial biopsy pathology report.

Definition

Per the American College of Surgeons Optimal Resources for Cancer Care-2020 Standards Standard 5.5

Local Excision for Primary Cutaneous Melanoma, the clinical margin width for wide local excision of

invasive melanoma should be 1 cm for melanomas <1 mm thick, 1 to 2 cm for invasive melanomas 1 to 2

mm thick, and 2 cm for invasive melanomas >2 mm thick. The clinical margin width for wide local

excision of a melanoma in situ should be at least 5 mm.

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2023+

For cases diagnosed 2018-2022, leave this SSDI blank

Note 2: “The appropriate [wide local excision] margins are measured from the periphery of any gross

residual tumor or the edges of the entire previous biopsy scar (shave or excisional).” Operative

Standards for Cancer Surgery, Volume 2, page 392.

Note 3: Code the peripheral surgical margins from the operative report from a wide excision

Do not use the pathology report to code this data item.

Margins from wide excision-Measured from the edge of the lesion or the prior excision scar to

the peripheral margin of the specimen, do not use deep margin

Do not add margins together

If multiple wide excisions are performed, code the clinical margin width from the procedure

with the largest margin

Note 4: Physician statement of clinical margin width can be used to code this data item when no other

information is available, or the available information is ambiguous

Order of priority

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Operative Note

Physician statement in medical record

Note 5: Record stated margin in centimeters. Include decimal point.

Examples:

0.5 cm - 0.5

1 cm- 1.0

.5 cm - 2.5

Code

Description

0.1 Documented as 0.1cm or less (1mm or less)

0.2-9.9 0.2 cm – 9.9 cm

XX.1 10 centimeters or greater

XX.8 Not Applicable. Information not collected for this schema

(If this information is required by your standard setter, use of code XX.8 may

result in an edit error)

XX.9 Not documented in medical record

No Wide Excision performed

Mohs or similar procedure

Wide Excision performed, but clinical margin width not documented.

No surgical resection performed (B000)

Unknown if procedure performed.

BLANK N/A-Diagnosis year is prior to 2023.

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BREAST

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Estrogen Receptor and Progesterone Receptor

Definition

Estrogen receptor (ER) positivity and progesterone receptor (PR) positivity are favorable prognostic

factors in breast cancer, as well as endometrial carcinoma and meningioma. Positive results predict a

favorable response to endocrine (hormonal) therapy. Combined ER and PR positivity is associated with

increased response to antiestrogen therapies.

There are a variety of ways to report information on ER and PR results, but there is almost always a

summary statement that the result is positive or negative.

The following data items are used to collect ER and PR information

3826: Estrogen Receptor Percent Positive or Range

3827: Estrogen Receptor Summary

3828: Estrogen Receptor Total Allred Score

3914: Progesterone Receptor Percent Positive or Range

3915: Progesterone Receptor Summary

3916: Progesterone Receptor Total Allred Score

Note: Do not use results from the following tests to record ER or PR results

Oncotype Dx

MammaPrint

EndoPredict

PAM 50 (Prosigna)

Any other test that records HER2

The two most common ways to report ER and PR results are the percentage of cells with nuclear

positivity and the average intensity of staining. Both the PS and IS are based on

immunohistochemical staining of tumor cells.

ER and PR status, the percentage of tumor cells with positive nuclear staining, may be reported as a

specific number or a range if more than 10%. Intensity refers to degree of nuclear positivity (i.e.,

pale to dark); average intensity of staining is recorded as weak, moderate or strong.

ER or PR Status

___ Positive

Percentage of cells with nuclear positivity

Specify: ___ %

-OR-

Range (Note A)

___ 1-10% (specify): ____ %

___ 11-20%

___ 21-30%

___ 31-40%

___ 41-50%

___ 51-60%

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___ 61-70%

___ 71-80%

___ 81-90%

___ 91-100%

+ Average intensity of staining:

+ ___ Weak

+ ___ Moderate

+ ___ Strong

___ Negative

Allred Score for Estrogen and Progesterone Receptor Evaluation

The Allred Score is a method of quantifying ER and PR using both intensity and percentage of positive

cells. The Allred Score is calculated by adding the Proportion Score and the Intensity Score, as defined in

the tables below.

The Allred score combines the percentage of positive cells (proportion score) and the intensity score of

the reaction product in most of the carcinoma. The 2 scores are added together for a final score with 8

possible values (00-08).

Proportion Score Positive Cells, %

0 0

1 <1

2 1 to 10

11 to 33

34 to 66

Intensity Intensity Score

None 0

Weak 1

Intermediate/Moderate

Strong 3

Additional Information

For further information, refer to the Breast or Breast Biomarker Reporting cancer protocols

published by the College of American Pathologists for the AJCC Staging System Breast

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3827: Estrogen Receptor Summary

Item Length: 1

NAACCR Item #: 3827

XML Parent-NAACCR ID: Tumor-estrogenReceptorSummary

NAACCR Alternate Name: ER (Estrogen Receptor) Summary

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Estrogen Receptor Summary is a summary of results of the estrogen receptor (ER) assay.

Rationale

This data item is required for prognostic stage grouping in AJCC 8

edition, Chapter 48, Breast. It was

previously collected as Breast CS SSF # 1.

Coding guidelines

Record the pathologist’s interpretation of the assay value from the tumor specimen. Results from the

ER assay done prior to neoadjuvant therapy take priority. If there are no results prior to neoadjuvant

treatment, code the results from a post-treatment specimen. Do not report the results of an ER or PR

done as part of a multigene test such as OncotypeDX or MammaPrint.

Code 0 when the ER is reported as negative or normal

Code 1 when the ER is reported as positive or elevated

Code 7 when the ER test was ordered but the results are not available

Code 9 when the ER is

o Reported as borderline; undetermined whether positive or negative

o Cannot be determined by the pathologist (e.g. inadequate specimen)

o It is unknown whether the ER test was performed

o The patient has only a clinical diagnosis of breast cancer (no tissue diagnosis)

See 3826-3827, 3914-3916: Estrogen Receptor and Progesterone Receptor for additional information.

Coding Instructions and Codes

Note 1: Physician statement of ER (Estrogen Receptor) Summary status can be used to code this data

item when no other information is available.

Note 2: The result of the ER test performed on the primary breast tissue is to be recorded in this data

item.

Note 3: Results from nodal or metastatic tissue may be used ONLY when there is no evidence of in situ

or invasive carcinoma in the primary tumor.

Note 4: In cases where there are invasive and in situ components in the primary tumor and ER is done

on both, ignore the in situ results.

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If ER is positive on an in situ component and ER is negative on all tested invasive components in

the primary tumor, code ER as negative (code 0)

If in situ and invasive components present and ER only done on the in situ component in the

primary tumor, code unknown (code 9)

Note 5: In cases where there is a single tumor with multiple biopsies and/or surgical resection with

different ER results.

Use the highest (positive versus negative)

Note 6: In cases where there are multiple tumors with different ER results, code the results from the

largest tumor size (determined either clinically or pathologically) when multiple tumors are present.

Do not use specimen size to determine the largest tumor size

Note 7: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy. If neoadjuvant therapy is given and there are no ER results from pre-treatment specimens,

report the findings from post-treatment specimens.

Note 8: If the patient is ER positive and node negative, a multigene test such as Oncotype Dx may be

performed, in which case another ER test will be performed. Do not record the results of that test in

this field.

Record only the results of the test which made the patient eligible to be given the multigene test

Code Description

0 ER negative (0.0% or less than 1%)

1 ER positive

Test ordered, results not in chart

9 Not documented in medical record

Cannot be determined (indeterminate)

ER (Estrogen Receptor) Summary status not assessed or unknown if

assessed

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3826: Estrogen Receptor Percent Positive or Range

Item Length: 3

NAACCR Item #: 3826

XML Parent-NAACCR ID: Tumor-estrogenReceptorPercntPosOrRange

NAACCR Alternate Name: ER (Estrogen Receptor) Percent Positive or Range

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Estrogen Receptor Percent Positive or Range is the percent of cells staining estrogen receptor positive

by IHC.

Rationale

Estrogen Receptor Percent Positive or Range is a Registry Data Collection Variable in AJCC. It is a new

data item for cases diagnosed 1/1/2018+.

See 3826-3827, 3914-3916: Estrogen Receptor and Progesterone Receptor for additional information.

Coding Instructions and Codes

Note 1: Physician statement of ER Percent Positive or Range can be used to code this data item.

Note 2: Code this data item using the same report used to record 3827: Estrogen Receptor Summary.

Note 3: If ER is negative, or percentage is less than 1%, code 000.

Note 4: The actual ER (1-100%) percent takes priority over the range codes.

Note 5: If ER is positive but percentage is unknown, code XX7.

Note 6: Ranges for the codes in this data item are defined in steps of 10 which correspond to the CAP

protocol. If a range in a report is given in steps other than those provided in the codes, code to the

range that contains the lowest number of the range in the report.

Example 1: Report says 1-5%. Code R10 (1-10%)

Example 2: Report says 90-95%. Code R90 (81-90%)

Code Description

000 ER negative, or stated as less than 1%

001-100 1-100 percent

R10 Stated as 1-10%

R20 Stated as 11-20%

R30 Stated as 21-30%

R40 Stated as 31-40%

R50 Stated as 41-50%

R60 Stated as 51-60%

R70 Stated as 61-70%

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Code Description

R80 Stated as 71-80%

R90 Stated as 81-90%

R99 Stated as 91-100%

XX7 Test done, results not in chart

XX8

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XX8 will result in an edit error.)

XX9

Not documented in medical record

ER (Estrogen Receptor) Percent Positive or Range not assessed or unknown if assessed

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00480: Breast (2018+)

3828: Estrogen Receptor Total Allred Score

Item Length: 2

NAACCR Item #: 3828

XML Parent-NAACCR ID: Tumor-estrogenReceptorTotalAllredScore

NAACCR Alternate Name: ER (Estrogen Receptor) Total Allred Score

Active years: 2018-2022

Schemas(s):

00480: Breast (2018+)

Description

Estrogen Receptor Total Allred Score is based on the percentage of cells that stain positive by IHC for

estrogen receptor (ER) and the intensity of that staining.

Rationale

Estrogen Receptor Total Allred Score is a Registry Data Collection Variable in AJCC. It is a new data item

for cases diagnosed 1/1/2018+.

See 3826-3827, 3914-3916: Estrogen Receptor and Progesterone Receptor for additional information.

Coding Instructions and Codes

Note 1: This SSDI is no longer required by any of the standard setters starting with 2023 diagnoses.

For cases diagnosed 2023+, this SSDI may be left blank

Note 2: Physician statement of ER (Estrogen Receptor) Total Allred Score can be used to code this data

item.

Note 3: Code this data item using the same report used to record 3827: Estrogen Receptor Summary.

Note 4: The Allred system looks at what percentage of cells test positive for hormone receptors, along

with how well the receptors show up after staining (this is called “intensity”). This information is then

combined to score the sample on a scale from 0 to 8. The higher the score, the more receptors were

found and the easier they were to see in the sample.

The registrar should not calculate the Allred score unless both components are available

(proportion score and intensity)

See the Allred Score for Estrogen and Progesterone Receptor Evaluation section in the SSDI

manual for assistance in determining the Allred Score

Note 5: If ER test is performed, but Allred score is not documented, or cannot be calculated, code X9.

Code Description

00 Total ER Allred score of 0

01 Total ER Allred score of 1

02 Total ER Allred score of 2

03 Total ER Allred score of 3

04 Total ER Allred score of 4

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Code Description

05 Total ER Allred score of 5

06 Total ER Allred score of 6

07 Total ER Allred score of 7

08 Total ER Allred score of 8

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

Not documented in medical

record

ER (Estrogen Receptor) Total Allred Score not assessed, or unknown if assessed

<Blank> NA-Diagnosis years is after 2022

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00480: Breast (2018+)

3915: Progesterone Receptor Summary

Item Length: 1

NAACCR Item #: 3915

XML Parent-NAACCR ID: Tumor-progesteroneRecepSummary

NAACCR Alternate Name: PR (Progesterone Receptor) Summary

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Progesterone Receptor Summary is a summary of results from the progesterone receptor (PR) assay.

Rationale

This data item is required for prognostic stage grouping in AJCC 8

edition, Chapter 48 Breast. It was

previously collected as Breast CS SSF # 2.

Coding guidelines

Code 0 when the PR is reported as negative or normal

Code 1 when the PR is reported as positive or elevated

Code 7 when the PR test was ordered but the results are not available

Code 9 when the PR is

o Reported as borderline; undetermined whether positive or negative

o Cannot be determined by the pathologist (e.g. inadequate specimen)

o It is unknown whether the PR test was performed

o The patient has only a clinical diagnosis of breast cancer (no tissue diagnosis)

See 3826-3827, 3914-3916: Estrogen Receptor and Progesterone Receptor for additional information.

Coding Instructions and Codes

Note 1: Physician statement of PR (Progesterone Receptor) Summary status can be used to code this

data item when no other information is available.

Note 2: The result of the PR test performed on the primary breast tissue is to be recorded in this data

item.

Note 3: Results from nodal or metastatic tissue may be used ONLY when there is no evidence of in situ

or invasive carcinoma in the primary tumor.

Note 4: In cases where there are invasive and in situ components in the primary tumor and PR is done

on both, ignore the in situ results.

If PR is positive on an in situ component and PR is negative on all tested invasive components in

the primary tumor, code PR as negative (code 0)

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If in situ and invasive components present and PR only done on the in situ component in the

primary tumor, code unknown (code 9)

Note 5: In cases where there is a single tumor with multiple biopsies and/or surgical resection with

different PR results.

Use the highest (positive versus negative)

Note 6: In cases where there are multiple tumors with different PR results, code the results from the

largest tumor size (determined either clinically or pathologically) when multiple tumors are present.

Do not use specimen size to determine the largest tumor size

Note 7: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy. If neoadjuvant therapy is given and there are no PR results from pre-treatment specimens,

report the findings from post-treatment specimens.

Note 8: If the patient is PR positive and node negative, a multigene test such as Oncotype Dx may be

performed, in which case another PR test will be performed. Do not record the results of that test in

this field.

Record only the results of the test which made the patient eligible to be given the multigene test

Code Description

0 PR negative (0.0% or less than 1%)

1 PR positive

7 Test ordered, results not in chart

9 Not documented in medical record

Cannot be determined (indeterminate)

PR (Progesterone Receptor) Summary status not assessed or

unknown if assessed

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00480: Breast (2018+)

3914: Progesterone Receptor Percent Positive or Range

Item Length: 3

NAACCR Item #: 3914

XML Parent-NAACCR ID: Tumor-progesteroneRecepPrcntPosOrRange

NAACCR Alternate Name: PR (Progesterone Receptor) Percent Positive or Range

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Progesterone Receptor Percent Positive or Range is the percent of cells staining progesterone receptor

positive measured by IHC.

Rationale

Progesterone Receptor Percent Positive or Range is a Registry Data Collection Variable in AJCC. It is a

new data item for cases diagnosed 1/1/2018+.

See 3826-3827, 3914-3916: Estrogen Receptor and Progesterone Receptor for additional information.

Coding Instructions and Codes

Note 1: Physician statement of PR (Progesterone Receptor) Percent Positive or Range can be used to

code this data item.

Note 2: Code this data item using the same report used to record 3915: Progesterone Receptor

Summary.

Note 3: If PR is negative, or percentage is less than 1%, code 000.

Note 4: The actual PR (1-100%) percent takes priority over the range codes.

Note 5: If PR is positive but percentage is unknown, code XX7.

Note 6: Ranges for the codes in this data item are defined in steps of 10 which correspond to the CAP

protocol. If a range in a report is given in steps other than those provided in the codes, code to the

range that contains the lowest number of the range in the report.

Example 1: Report says 1-5%. Code R10 (1-10%)

Example 2: Report says 90-95%. Code R90 (81-90%)

Code Description

000

PR negative, or stated as less than 1%

001-100 1-100 percent

R10 Stated as 1-10%

R20 Stated as 11-20%

R30 Stated as 21-30%

R40 Stated as 31-40%

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Code Description

R50 Stated as 41-50%

R60 Stated as 51-60%

R70 Stated as 61-70%

R80 Stated as 71-80%

R90 Stated as 81-90%

R99

Stated as 91

100%

XX7 Test done, results not in chart

XX8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XX8 will result in an edit

error.)

XX9

Not documented in medical record

PR (Progesterone Receptor) Percent Positive or Range not assessed or unknown if

assessed

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3916: Progesterone Receptor Total Allred Score

Item Length: 2

NAACCR Item #: 3916

XML Parent-NAACCR ID: Tumor-progesteroneRecepTotalAllredScor

NAACCR Alternate Name: PR (Progesterone Receptor) Total Allred Score

Active years: 2018-2022

Schemas(s):

00480: Breast (2018+)

Description

Progesterone Receptor, Total Allred Score is based on the percentage of cells that stain by IHC for

progesterone receptor (PR) and the intensity of that staining.

Rationale

Progesterone Receptor, Total Allred Score is a Registry Data Collection Variable in AJCC. It is a new data

item for cases diagnosed 1/1/2018+.

See 3826-3827, 3914-3916: Estrogen Receptor and Progesterone Receptor for additional information.

Coding Instructions and Codes

Note 1: This SSDI is no longer required by any of the standard setters starting with 2023 diagnoses.

For cases diagnosed 2023+, this SSDI may be left blank

Note 2: Physician statement of PR (Progesterone Receptor) Total Allred Score can be used to code this

data item.

Note 3: Code this data item using the same report used to record 3915: Progesterone Receptor

Summary.

Note 4: The Allred system looks at what percentage of cells test positive for hormone receptors, along

with how well the receptors show up after staining (this is called “intensity”). This information is then

combined to score the sample on a scale from 0 to 8. The higher the score, the more receptors were

found and the easier they were to see in the sample.

The registrar should not calculate the Allred score unless both components are available

(proportion score and intensity)

See the Allred Score for Estrogen and Progesterone Receptor Evaluation section in the SSDI

manual for assistance in determining the Allred Score

Note 5: If PR test is performed, but Allred score is not documented, or it cannot be calculated, code X9.

Code

Description

Total PR Allred score of 0

01 Total PR Allred score of 1

02 Total PR Allred score of 2

03 Total PR Allred score of 3

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Code Description

04 Total PR Allred score of 4

05 Total PR Allred score of 5

06 Total PR Allred score of 6

07 Total PR Allred score of 7

08 Total PR Allred score of 8

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit

error.)

X9 Not documented in medical record

PR (Progesterone Receptor) Total Allred Score not assessed, or unknown if

assessed

<Blank>

Diagnosis years is after 2022

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HER2

Definition

A subset of breast carcinomas (approximately 15% to 20%) overexpress human epidermal growth factor

receptor 2 (HER2). The presence of HER2 overexpression in untreated patients is associated with worse

prognosis in both node-negative and node-positive patients. Protein overexpression is usually due to

HER2 gene amplification. The HER2 protein may also be referred to as ERBB2 and the HER2 gene may

also be referred to as the ERBB2 gene.

The development of HER-2 targeting agents for the treatment of HER2 positive breast cancer has

dramatically improved outcomes for patients with HER2 positive breast cancers. HER2 status is

primarily evaluated to determine patient eligibility for anti-HER2 therapy.

The following data items are used to collect HER2 information:

3850: HER2 IHC Summary

3851: HER2 ISH Dual Probe Copy Number

3852: HER2 ISH Dual Probe Ratio

3853: HER2 ISH Single Probe Copy Number

3854: HER2 ISH Summary

3855: HER2 Overall Summary

The simplest test used is the IHC (immunohistochemistry). If the IHC test is borderline or indeterminate,

an ISH (in situ hybridization) test may be performed.

The results of the IHC test are reported as follows:

Reporting Results of HER2 Testing by Immunohistochemistry (IHC)

Result

Criteria

Negative (Score 0)

No staining observed

tumor cells

Negative (Score 1+) Incomplete, faint/barely perceptible membrane staining in >10% of invasive

tumor cells*

Equivocal (Score 2+)

Incomplete and/or weak to moderate circumferential membrane staining in

>10% of invasive tumor cells

tumor cells*

Positive (Score 3+) Complete, intense, circumferential membrane staining in >10% of invasive

tumor cells*

If the IHC test is borderline or indeterminate, an ISH test may be performed. The ISH test is a method of

testing for overexpression of the HER2 gene that uses fluorescent pieces of DNA that attach only to the

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HER2 gene copies in cells, which can then be counted under a special microscope. ISH studies

determine the presence or absence of gene amplification and methods include fluorescence in situ

hybridization (FISH), chromogenic in situ hybridization (CISH), and silver-enhanced in situ hybridization

(SISH). Some assays use a single probe to determine the number of HER2 gene copies present (single-

probe assays) and others include a chromosome enumeration probe (CEP17) to determine the ratio of

HER2 signals to copies of chromosome 17 (dual-probe assays).

Results from single probe and dual probe ISH tests are reported differently and are collected in different

data items. For dual probe tests, both HER2/CEP17 ratio and HER2 copy number results are collected in

separate data items.

Reporting Results of HER2 Testing by In Situ Hybridization (single-probe assay)

Result Criteria

Negative (not

amplified)

Average HER2 copy number <4.0 signals/cell

Equivocal Average HER2 copy nu

Positive (amplified) Average HER2

Reporting Results of HER2 Testing by In Situ Hybridization (dual-probe assay)

Result Criteria

Negative (not

amplified)

HER2/CEP17 ratio <2.0 AND average HER2 copy number <4.0 signals/cell

Equivocal HER2/CEP17

signals/cell

Positive (amplified) HER2/CEP17 (regardless of average HER2 copy number)

Average HER (regardless of ratio)

Note: TP52, SMSCR and RARA are gene genes that are also on chromosome 17. However, they are not

close to the centromere, and thus can be used to assess borderline/equivocal fish results (ratios) when

the centromeric probe for chromosome 17 (CEP17) performance may be problematic. Although these

may be helpful in some cases, they are not the same as the CEP17 result or the ratio determined from

CEP17. There should always be a prior CEP17 result when these other results are found in the chart. If

one of these tests (TP52, SMSCR, RARA, or others) are used and a dual probe copy number/ratio are

documented, record that results in the appropriate data item.

D17Z1 is the CEP17 probe used in the Vysis (Abbot) FISH kit. So, for the HER2 data items, D17Z1 and

CEP17 are to be treated as the same thing.

Changes from Collaborative Stage v2 (CSv2): In CSv2, there were multiple SSFs that collected

information on FISH, CISH, or other. In addition, the lab value and the interpretation were collected. For

2018 cases forward, only the interpretation will be recorded. Also, interpretation of all types of ISH tests

(FISH, CISH, SISH, single probe, double probe) are to be recorded in the overall ISH data item. If there are

multiple tests, record the highest.

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Note: HER2 results are to be recorded from IHC or ISH tests only. Do not use results from the following

tests to record HER2 results

Oncotype Dx

MammaPrint

EndoPredict

PAM 50 (Prosigna)

Any other test that records HER2

Additional Information

For further information, refer to the Breast or Breast Biomarker Reporting cancer protocols

published by the College of American Pathologists for the AJCC Staging System Breast

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00480: Breast (2018+)

3850: HER2 IHC Summary

Item Length: 1

NAACCR Item #: 3850

XML Parent-NAACCR ID: Tumor-her2IhcSummary

NAACCR Alternate Name: None

Active years: 2018-2020

Schemas(s):

00480: Breast (2018+)

Description

HER2 IHC Summary is the summary score for HER2 testing by IHC.

Rationale

HER2 IHC Summary is a Registry Data Collection Variable in AJCC. It is a new data item for cases

diagnosed 1/1/2018+.

See 3850-3855: HER2 for additional information.

Coding Instructions and Codes

Note 1: This SSDI is no longer required by any of the standard setters starting with 2021 diagnoses.

For cases diagnosed 2021+, this SSDI may be left blank

Note 2: Physician statement of HER2 IHC Summary can be used to code this data item when no other

information is available.

Note 3: The HER2 IHC test performed on the primary breast tissue is to be recorded in this data item.

Note 4: Results from nodal or metastatic tissue may be used, ONLY when there is no evidence of

primary tumor.

Note 5: In cases where there are invasive and in situ components and HER2 IHC is done on both, ignore

the in situ results.

If HER2 IHC is positive on an in situ component and HER2 IHC is negative on all tested invasive

components, code HER2 IHC as negative (code 0)

If in situ and invasive components present and HER2 IHC only done on the in situ component,

code unknown (code 9)

Note 6: In cases where there is a single tumor with multiple biopsies and/or surgical resection with

different HER2 IHC results.

Use the highest (positive versus negative)

Note 7: In cases where there are multiple tumors with different HER2 IHC results, code the results from

the largest tumor size (determined either clinically or pathologically) when multiple tumors are present.

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Do not use specimen size to determine the largest tumor size

Note 8: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no HER2 IHC results from pre-treatment

specimens, report the findings from post-treatment specimens.

Note 9: A 2+ (equivocal) finding by IHC should result in additional testing with ISH to determine gene

copy number.

Note 10: An immunohistochemistry (IHC) test identifies the protein expressed by the gene (ERBB2), and

an in situ hybridization (ISH) test identifies the number of copies of the gene (ERBB2) itself.

Note 11: HER2 is not routinely done on pure in situ tumors (behavior /2); however, if you have an in situ

tumor and there are HER2 results, go ahead and record it. Otherwise code 9.

Code Description

0 Negative (Score 0)

1 Negative (Score 1+)

2 Equivocal (Score 2+)

Stated as equivocal

Borderline

Positive (Score 3+)

Stated as positive

4 Stated as negative, but score not stated

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Cannot be determined (indeterminate)

HER2 IHC Summary not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is after 2020

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00480: Breast (2018+)

3854: HER2 ISH Summary

Item Length: 1

NAACCR Item #: 3854

XML Parent-NAACCR ID: Tumor-her2IshSummary

NAACCR Alternate Name: None

Active years: 2018-2020

Schemas(s):

00480: Breast (2018+)

Description

HER2 in situ hybridization (ISH) Summary is the summary score for results of testing for ERBB2 gene

copy number by any ISH method. An immunohistochemistry (IHC) test identifies the protein expressed

by the gene (ERBB2), and an ISH test identifies the number of copies of the gene (ERBB2) itself.

Rationale

HER2 ISH Summary is a Registry Data Collection Variable in AJCC. It is a new data item for cases

diagnosed 1/1/2018+.

See 3850-3855: HER2 for additional information.

Coding Instructions and Codes

Note 1: This SSDI is n o longer required by any of the standard setters starting with 2021 diagnoses.

For cases diagnosed 2021+, this SSDI may be left blank

Note 2: Physician statement of HER2 in situ hybridization (ISH) Summary can be used to code this data

item when no other information is available.

Note 3: The HER2 ISH test performed on the primary breast tissue is to be recorded in this data item.

Note 4: Results from nodal or metastatic tissue may be used, ONLY when there is no evidence of

primary tumor.

Note 5: Any type of ISH test (e.g., FISH, CISH, SISH) can be used to code this data item. The same test

should be used to code all the HER2 ISH data items.

Note 6: In cases where there are invasive and in situ components and HER2 ISH is done on both, ignore

the in situ results.

If HER2 ISH is positive on an in situ component and HER2 ISH is negative on all tested invasive

components, code HER2 ISH as negative (code 0)

If in situ and invasive components present and HER2 ISH only done on the in situ component,

code unknown (code 9)

Note 7: In cases where there is a single tumor with multiple biopsies and/or surgical resection with

different HER2 ISH results.

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Use the highest (positive versus negative)

Note 8: In cases where there are multiple tumors with different HER2 ISH results, code the results from

the largest tumor size (determined either clinically or pathologically) when multiple tumors are present.

Do not use specimen size to determine the largest tumor size

Note 9: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no HER2 ISH results from pre-treatment

specimens, report the findings from post-treatment specimens.

Note 10: An immunohistochemistry (IHC) test identifies the protein expressed by the gene (ERBB2), and

an ISH test identifies the number of copies of the gene (ERBB2) itself.

Note 11: HER2 is not routinely done on pure in situ tumors (behavior /2); however, if you have an in situ

tumor and there are HER2 results, go ahead and record it. Otherwise code 9.

Code Description

0 Negative [not amplified]

2 Equivocal

3 Positive [amplified]

7 Test ordered, results not in chart

Not applicable: Information not

collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit

error.)

9 Not documented in medical record

Results cannot be determined (indeterminate)

Borderline

HER2 ISH Summary not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is after 2020

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00480: Breast (2018+)

3855: HER2 Overall Summary

Item Length: 1

NAACCR Item #: 3855

XML Parent-NAACCR ID: Tumor-her2OverallSummary

NAACCR Alternate Name: None

Active years: 2018+Schemas(s):

00480: Breast (2018+)

Description

HER2 Overall Summary is a summary of results from HER2 testing.

Rationale

This data item is required for prognostic stage grouping in AJCC 8

edition, Chapter 48 Breast. It was

previously collected as Breast, CS SSF # 15. Experts recommend that every invasive breast cancer be

tested for the presence of HER2 because anti-HER2 treatments are highly effective for these tumors.

HER2 overall summary It will be collected for Esophagus and Esophagogastric Junction and Stomach for

cases diagnosed 1/1/21+ because NCCN guidelines recommend HER2 testing at time of diagnosis if

patients are documented or suspected of having metastatic disease. HER2 monoclonal antibodies may

be added to chemotherapy for patients with HER2 positive disease.

See 3850-3855: HER2 for additional information.

Coding guidelines

Record the pathologist’s interpretation of the HER2 test from the tumor specimen. Results from the

HER2 test done prior to neoadjuvant therapy take priority. If there are no results prior to neoadjuvant

treatment, code the results from a post-treatment specimen. Do not report the results of a HER2 as

part of a multigene test such as OncotypeDX or MammaPrint.

If assays are performed on more than one specimen and any result is interpreted as positive, code as 1

Positive/elevated.

Exception: If results from both an in situ specimen and an invasive component are given, record the

results from the invasive specimen, even if the in situ is positive and the invasive specimen is negative.

Code 0 when the HER2 is reported as negative or normal

Code 1 when the HER2 is reported as positive or elevated

Code 7 when the HER2 test was ordered but the results are not available

Code 9 when the HER2 is

o Reported as borderline; undetermined whether positive or negative

o Cannot be determined by the pathologist (e.g. inadequate specimen)

o It is unknown whether the HER2 test was performed

o The patient has only a clinical diagnosis of breast cancer (no tissue diagnosis)

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Coding Instructions and Codes

Note 1: Physician statement of HER2 Overall Summary can be used to code this data item when no

other information is available.

Note 2: The result of the HER2 test performed on the primary breast tissue is to be recorded in this data

item.

Note 3: Results from nodal or metastatic tissue may be used ONLY when there is no evidence of in situ

or invasive carcinoma in the primary tumor.

Note 4: In cases where there are invasive and in situ components in the primary tumor and HER2 is done

on both, ignore the in situ results.

If HER2 is positive on an in situ component and HER2 is negative on all tested invasive

components in the primary tumor, code HER2 as negative (code 0)

If in situ and invasive components present and HER2 only done on the in situ component in the

primary tumor, code unknown (code 9)

Note 5: In cases where there is a single tumor with multiple biopsies and/or surgical resection with

different HER2 results.

Use the highest (positive versus negative)

Note 6: In cases where there are multiple tumors with different HER2 results, code the results from the

largest tumor size (determined either clinically or pathologically) when multiple tumors are present.

Do not use specimen size to determine the largest tumor size

Note 7: If neoadjuvant therapy is given, record the assay from tumor specimens prior to neoadjuvant

therapy.

If neoadjuvant therapy is given and there are no HER2 results from pre-treatment specimens,

report the findings from post-treatment specimens

Note 8: If the patient is HER2 positive and node negative, a multigene test such as Oncotype Dx may be

performed, in which case another HER2 test will be performed. Do not record the results of that test in

this field.

Record only the results of the test which made the patient eligible to be given the multigene test

Note 9: HER2 is not routinely done on pure in situ tumors (behavior /2); however, if you have an in situ

tumor and there are HER2 results, go ahead and record it. Otherwise code 9

Code Description

0 HER2 negative; equivocal

1 HER2 positive

7 Test ordered, results not in chart

9 Not documented in medical record

Cannot be determined (indeterminate)

Borderline

HER2 Overall Summary status not assessed or unknown if assessed

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00480: Breast (2018+)

3853: HER2 ISH Single Probe Copy Number

Item Length: 4

NAACCR Item #: 3853

XML Parent-NAACCR ID: Tumor-her2IshSingleProbeCopyNumber

NAACCR Alternate Name: None

Active years: 2018-2020

Schemas(s):

00480: Breast (2018+)

Description

HER2 in situ hybridization (ISH) Single Probe Copy Number is the HER2 copy number based on a single

probe test.

Rationale

HER2 ISH Single Probe Copy Number is a Registry Data Collection Variable in AJCC. It is a new data item

for cases diagnosed 1/1/2018+.

See 3850-3855: HER2 for additional information.

Coding Instructions and Codes

Note 1: This SSDI is no longer required by any of the standard setters starting with 2021 diagnoses.

For cases diagnosed 2021+, this SSDI may be left blank

Note 2: Physician statement of HER2 in situ hybridization (ISH) Single Probe Copy Number can be used

to code this data item.

Note 3: A single probe test will report average number or mean signals per cell for HER2. Record the

HER2 average number or mean signals per cells in this data item. The average number or mean signals

per cell is also called the copy number.

Example:

SISH RESULTS: FINAL HER 2 IN SITU HYBRIDIZATION INTERPRETATION: POSITIVE (>6 gene copies)

HER-2/neu gene amplification.

HER-2/neu SILVER IN SITU HYBRIDIZATION (SISH)

HER-2neu gene (Inform HER2 DNA probe)

Number of tumor cell nuclei counted: 60

Number of Her-2/neu gene copies: 418

Mean HER-2/neu gene copy number: 6.9

Code Single Probe HER2 Copy Number: 6.9

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[Note: This is calculated by dividing 418 by 60]

Note 4: Registrars are not to calculate the copy number.

Note 5: Following ASCO-CAP guidelines, a 2+ (equivocal) finding by immunohistochemistry (IHC) should

result in additional testing with ISH to determine gene copy number.

Note 6: Any type of ISH test (e.g., FISH, CISH, SISH) can be used to code this data item. Code this data

item using the same report used to record 3854: HER2 ISH Summary.

Note 7: A HER2 ISH test may be called “ERBB2.” ERBB2 is the standard symbol for the gene ‘erb-b2

receptor tyrosine kinase 2.’ An IHC test identifies the protein expressed by the gene, and an ISH test

identifies the gene itself.

Note 8: If a HER2 ISH single probe copy number test is done, and the results are between 4 and 6

(equivocal), dual probe tests are recommended.

Note 9: If the test results are presented to the hundredth decimal, ignore the hundredth decimal. Do

NOT round.

Example:

Reported as 6.97, code 6.9

Code Description

0.0-99.9 Reported HER2 copy number of 0.0-99.9

XX.1 Reported HER2 copy number of 100 or greater

XX.7 Test ordered, results not in chart

XX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XX.8 will result in an edit

error.)

XX.9 Not documented in medical record

Cannot be determined (indeterminate)

Single probe test not done; only dual probe test performed

HER2 ISH Single Probe Copy Number not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is after 2020

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00480: Breast (2018+)

3851: HER2 ISH Dual Probe Copy Number

Item Length: 4

NAACCR Item #: 3851

XML Parent-NAACCR ID: Tumor-her2IshDualProbeCopyNumber

NAACCR Alternate Name: None

Active years: 2018-2020

Schemas(s):

00480: Breast (2018+)

Description

HER2 in situ hybridization (ISH) Dual Probe Copy Number is the HER2 copy number based on a dual

probe test.

Rationale

HER2 ISH Dual Probe Copy Number is a Registry Data Collection Variable in AJCC. It is a new data item

for cases diagnosed 1/1/2018+.

See 3850-3855: HER2 for additional information.

Coding Instructions and Codes

Note 1: This SSDI is no longer required by any of the standard setters starting with 2021 diagnoses.

For cases diagnosed 2021+, this SSDI may be left blank

Note 2: Physician statement of HER2 in situ hybridization (ISH) Dual Probe Copy Number can be used to

code this data item.

Note 3: A dual probe test will report average number or mean signals per cell for both HER2 and CEP17,

the latter used as a control. Record the HER2 average number or mean signals per cells in this data item.

The average number or mean signals per cells is also called the copy number.

Example:

SISH RESULTS: FINAL HER 2 IN SITU HYBRIDIZATION INTERPRETATION: EQUIVOCAL,

INDETERMINATE. HER2 gene copy between 4 & 6 with HER2/CEP17 ratio <2.

HER2/CEP17 RATIO: 4.26 / 3.13 = 1.36

HER-2/neu SILVER IN SITU HYBRIDIZATION (SISH)

HER-2neu gene (Inform HER2 DNA probe)

Number of tumor cell nuclei counted: 120

Number of Her-2/neu gene copies: 511

Mean HER-2/neu gene copy number: 4.26

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CEP-17 SILVER IN SITU HYBRIDIZATION (SISH)

CEP-17 (Inform Chromosome 17 probe)

Number of cell nuclei counted: 60

Number of CEP-17 gene copies: 188

Mean CEP-17 gene copies/nucl: 3.13

Code Dual Probe HER2 Copy Number: 4.2

[Note: This is calculated by dividing 511 by 120]

Note 4: Registrars are not to calculate the copy number.

Note 5: Following ASCO-CAP guidelines, a 2+ (equivocal) finding by immunohistochemistry (IHC) should

result in additional testing with ISH to determine gene copy number.

Note 6: Any type of ISH test (e.g., FISH, CISH, SISH) can be used to code this data item. Code this data

item using the same report used to record 3854: HER2 ISH Summary.

Note 7: A HER2 ISH test may be called “ERBB2.” ERBB2 is the standard symbol for the gene ‘erb-b2

receptor tyrosine kinase 2.’ An IHC test identifies the protein expressed by the gene, and an ISH test

identifies the gene itself.

Note 8: If a HER2 ISH single probe copy number test is done, and the results are between 4 and 6

(equivocal), dual probe tests are recommended.

Note 9: If the test results are presented to the hundredth decimal, ignore the hundredth decimal. Do

NOT round.

Example:

Reported as 4.99, code as 4.9

Code Description

0.0-99.9 Reported HER2 copy number of 0.0-99.9

XX.1 Reported HER2 copy number of 100 or greater

XX.7 Test ordered, results not in chart

XX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XX.8 will result in an edit

error.)

XX.9 Not documented in medical record

Cannot be determined (indeterminate)

Dual probe test note done; only single probe test performed

HER2 ISH Dual Probe Copy Number not assessed or unknown if assessed

<Blank>

N/A

Diagnosis year is

after 2020

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00480: Breast (2018+)

3852: HER2 ISH Dual Probe Ratio

Item Length: 4

NAACCR Item #: 3852

XML Parent-NAACCR ID: Tumor-her2IshDualProbeRatio

NAACCR Alternate Name: None

Active years: 2018-2020

Schemas(s):

00480: Breast (2018+)

Description

HER2 ISH Dual Probe Ratio is the summary score for HER2 testing using a dual probe. The test will

report results for both HER2 and CEP17, the latter used as a control. The HER2/CEP17 ratio is reported.

Rationale

HER2 ISH Dual Probe Ratio is a Registry Data Collection Variable in AJCC. It is a new data item for cases

diagnosed 1/1/2018+.

See 3850-3855: HER2 for additional information.

Coding Instructions and Codes

Note 1: This SSDI is no longer required by any of the standard setters starting with 2021 diagnoses.

For cases diagnosed 2021+, this SSDI may be left blank

Note 2: Physician statement of HER2 in situ hybridization (ISH) Dual Probe Ratio can be used to code this

data item.

Note 3: A dual probe test will report results for both HER2 and CEP17, the latter used as a control. The

HER2/CEP17 ratio will be reported. Record the ratio in this data item.

Example:

SISH RESULTS: FINAL HER 2 IN SITU HYBRIDIZATION INTERPRETATION: EQUIVOCAL,

INDETERMINATE. HER2 gene copy between 4 & 6 with HER2/CEP17 ratio <2.

HER2/CEP17 RATIO: 4.26 / 3.13 = 1.36

HER-2/neu SILVER IN SITU HYBRIDIZATION (SISH)

HER-2neu gene (Inform HER2 DNA probe)

Number of tumor cell nuclei counted: 120

Number of Her-2/neu gene copies: 511

Mean HER-2/neu gene copy number: 4.26

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CEP-17 SILVER IN SITU HYBRIDIZATION (SISH)

CEP-17 (Inform Chromosome 17 probe)

Number of cell nuclei counted: 60

Number of CEP-17 gene copies: 188

Mean CEP-17 gene copies/nucl: 3.13

Code Dual Probe HER2 Copy Number: 4.2

Code Dual Probe Ratio: 1.3

Note 4: Registrars are not to calculate the ratio.

Note 5: Following ASCO-CAP guidelines, a 2+ (equivocal) finding by immunohistochemistry (IHC) should

result in additional testing with ISH to determine gene copy number.

Note 6: Any type of ISH test (e.g., FISH, CISH, SISH) can be used to code this data item. Code this data

item using the same report used to record 3854: HER2 ISH Summary.

Note 7: A HER2 ISH test may be called “ERBB2.” ERBB2 is the standard symbol for the gene ‘erb-b2

receptor tyrosine kinase 2.’ An IHC test identifies the protein expressed by the gene, and an ISH test

identifies the gene itself.

Note 8: If the test results are presented to the hundredth decimal, ignore the hundredth decimal. Do

NOT round.

Example:

Reported as 1.99, code as 1.9

Code Description

0.0-99.9 Ratio of 0.0 to 99.9

XX.2 Less than 2.0

XX.3 Greater than or equal to 2.0

XX.7 Test ordered, results not in chart

XX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XX.8 will result in an

edit error.)

XX.9 Not documented in medical record

Results cannot be determined (indeterminate)

Dual probe test not done; only single probe test performed

HER2 ISH Dual Probe Ratio not assessed or unknown if assessed

<Blank> N/A-Diagnosis year is after 2020

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00480: Breast (2018+)

Multigene Signature Method and Results

Definition

Multigene testing is usually done for node-negative female breast cancer patients to predict risk of

recurrence within a specified time period or to predict the likelihood that the patient will respond to

specific types of chemotherapy. Multigene testing helps tailor treatment for the woman’s specific

cancer characteristics. Recent studies indicate that these tests may also be helpful in planning

treatment and predicting recurrence in node positive women with small tumors. Some types of tests

may be specific to ER positive or negative patients or women in a certain age range. Many different

types of genetic testing are available, including IHC-, FISH-, RT-PCR-, and genomic microarray-based

multigene predictors.

For the Breast cases, there are 2 data items that record information on Multigene testing.

3894: Multigene Signature Method

3895: Multigene Signature Results

These two fields record the type of multigene signature test that was performed. Both fields should be

coded from the same test, which may not be available at the time of diagnosis

Note: In Collaborative Stage v2 (CSv2), Oncotype was included in these two data items.

Oncotype has now been moved to separate data items. See the “Oncotype Dx” section of this

manual for more information.

Information is collected on the following tests

MammaPrint: A genomic test that analyzes the activity of certain genes in early-stage breast

cancer. Developed to help make treatment decisions based on the cancer's risk of coming back

(recurrence) within 10 years after diagnosis.

PAM 50 (Prosigna): PAM50 stands for Prediction Analysis of Microarray 50. It tests a sample of

the tumor (removed during a biopsy or surgery) for a group of 50 genes. Along with other

factors, the results of the PAM50 (Prosigna) test help predict the chance of metastasis (when

cancer spreads to other organs). Prosigna also helps to determine the molecular subtype of

breast cancer.

Breast Cancer Index: Analyzes the activity of seven genes to help predict the risk of node-

negative, hormone-receptor-positive breast cancer coming back 5 to 10 years after diagnosis.

The test can help women and their doctors decide if extending hormonal therapy 5 more years

(for a total of 10 years of hormonal therapy) would be beneficial. The Breast Cancer Index

reports two scores: how likely the cancer is to recur 5 to 10 years after diagnosis and how likely

a woman is to benefit from taking hormonal therapy for a total of 10 years.

EndoPredict: A genomic test for people newly diagnosed with early-stage, estrogen-receptor-

positive, HER2-negative breast cancer. May be used to help make treatment decisions based on

the cancer's risk of coming back in a part of the body away from the breast (distant metastasis)

within 10 years after diagnosis. The EndoPredict test provides a risk score that is either low-risk

or high-risk of breast cancer recurring as distant metastasis. Knowing if the cancer has a high or

low risk of recurrence can help women and their doctors decide if chemotherapy or other

treatments to reduce risk after surgery are needed.

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Additional Information

Source documents: specialty reference laboratories (private companies with proprietary testing

methods); the actual report may be included in the medical record or may be referenced by the

clinician.

Other names: genomic profiling, multigene testing, multigene assay, microarray assay,

molecular diagnostics for treatment planning

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00480: Breast (2018+)

3894: Multigene Signature Method

Item Length: 1

NAACCR Item #: 3894

XML Parent-NAACCR ID: Tumor-multigeneSignatureMethod

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Multigene signatures or classifiers are assays of a panel of genes from a tumor specimen, intended to

provide a quantitative assessment of the likelihood of response to chemotherapy and to evaluate

prognosis or the likelihood of future metastasis. This data item identifies the multigene signature

method used. Oncotype Dx is coded elsewhere.

Rationale

Multigene Signature Method is a Registry Data Collection Variable in AJCC. It was previously collected as

Breast, CS SSF #22. See also Multigene Signature Results.

See 3894, 3895: Multigene Signature Method and Results for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the Multigene Signature Method can be used to code this data item.

Note 2: Multigene signatures or classifiers are assays of a panel of genes from a tumor specimen,

intended to provide a quantitative assessment of the likelihood of response to chemotherapy and to

evaluate prognosis or the likelihood of future metastasis.

Only record tests done on tumor tissue that help determine if the cancer is likely to recur. Don’t

include other tests, such as those that evaluate hereditary mutations that influence a patient’s

risk of developing cancer (e.g. myRisk, BRCA)

Only record tests that are based on gene assays. Don’t include other tests which use a

multivariate data model to eliminate the need for genetic assays

Note 3: Code the type of test performed. The same test should be used to record information in 3895:

Multigene Signature Results .

Note 4: Oncotype Dx tests are not recorded in this data item. See the following data items for Oncotype

Dx.

3903: Oncotype Dx Recurrence Score-DCIS

3904: Oncotype Dx Recurrence Score-Invasive

3905: Oncotype Dx Risk Level-DCIS

3906: Oncotype Dx Risk Level-Invasive

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Code Description

1 Mammaprint

2 PAM50 (Prosigna)

3 Breast Cancer Index

4 EndoPredict

5 Test performed, type of test unknown

Multiple tests, any tests in codes 1

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Multigene Signature Method not assessed or unknown if assessed

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00480: Breast (2018+)

3895: Multigene Signature Results

Item Length: 2

NAACCR Item #: 3895

XML Parent-NAACCR ID: Tumor-multigeneSignatureResults

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Multigene signatures or classifiers are assays of a panel of genes from a tumor specimen, intended to

provide a quantitative assessment of the likelihood of response to chemotherapy and to evaluate

prognosis or the likelihood of future metastasis. This data item identifies the multigene signature result.

Oncotype Dx is coded elsewhere.

Rationale

Multigene Signature Results is a Registry Data Collection Variable in AJCC. It was previously collected as

Breast, CS SSF #23. See also Multigene Signature Method.

See 3894, 3895: Multigene Signature Method and Results for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the Multigene Signature Results can be used to code this data item.

Note 2: Multigene signatures or classifiers are assays of a panel of genes from a tumor specimen,

intended to provide a quantitative assessment of the likelihood of response to chemotherapy and to

evaluate prognosis or the likelihood of future metastasis.

Only record tests done on tumor tissue that help determine if the cancer is likely to recur. Don’t

include other tests, such as those that evaluate hereditary mutations that influence a patient’s

risk of developing cancer (e.g. myRisk, BRCA)

Only record tests that are based on gene assays. Don’t include other tests which use a

multivariate data model to eliminate the need for genetic assays

Note 3: Code the score or risk for the test performed. The same test should be used to record

information in 3894: Multigene Signature Method.

Note 4: Oncotype Dx tests are not recorded in this data item. See the following data items for Oncotype

Dx.

3903: Oncotype Dx Recurrence Score-DCIS

3904: Oncotype Dx Recurrence Score-Invasive

3905: Oncotype Dx Risk Level-DCIS

3906: Oncotype Dx Risk Level-Invasive

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Note 5: PAM50 (Prosigna) is a single numeric score of 0-100. If the score is available, record the score. If

only the risk level is available, record that.

Note 6: For Mammaprint, EndoPredict, and Breast Cancer Index, only record the risk level.

Code Description

00-99 Enter actual recurrence score

Note: Depending on the test, the range of values may be different

X1 Score 100

X2 Low risk

X3 Moderate [intermediate] risk

X4 High risk

X7 Test ordered, results not in chart

X8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit

error.)

X9 Not documented in medical record

Multigene Signature Results not assessed or unknown if assessed

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00480: Breast (2018+)

Oncotype Dx Tests

The recording of Oncotype Dx was previously collected in Multigene Signature Results and Multigene

Signature Method in CSv2. Oncotype Dx now has four data items.

3903: Oncotype Dx Recurrence Score-DCIS

3904: Oncotype Dx Recurrence Score-Invasive

3905: Oncotype Dx Risk Level-DCIS

3906: Oncotype Dx Risk Level-Invasive

Oncotype DX DCIS Score

Definition

The Oncotype DX DCIS score is a genomic test that estimates the likelihood of local recurrence (DCIS or

invasive) for a patient with DCIS. The results may be used clinically to evaluate benefits of radiation

therapy following surgery.

The Oncotype DX DCIS score, a numeric value from 0-100, is coded in NAACCR Data Item #3903.

Oncotype DX DCIS Risk Level, coded in NAACCR Data Item #3905, stratifies the Oncotype DX DCIS Score

into three risk levels

Low risk: Recurrence Score lower than 39: The DCIS has a lower risk of recurrence.

Intermediate Risk: Recurrence Score between 39 and 54: The DCIS has an intermediate risk of

recurrence.

High risk: Recurrence Score greater than 54: The DCIS has a higher risk of recurrence.

Additional Information

Source documents: Oncotype Dx DCIS laboratory report, other statements in medical record

For further information, see http://www.oncotypeiq.com/en-US/breast-cancer/patients-and-

caregivers/stage-0-dcis/about-the-test

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Oncotype DX Breast Recurrence Score

Definition

The Oncotype DX Breast Recurrence Score test (Oncotype DX) test is a genomic test that predicts the

risk of distant recurrence and likelihood of benefit chemotherapy for early stage breast cancers. It is

required for assigning prognostic stage in AJCC 8

edition for patients with T1-2 N0, M0, ER-positive,

HER2 negative breast cancers. Oncotype DX provides a quantitative score, based on a continuous scale

from 0-100, with higher scores reflecting higher risk of distant recurrence and higher likelihood of

chemotherapy benefit.

The numeric value of the recurrence score is coded in Data Item #3906. When the actual recurrence

score is not available, there is an option for coding recurrence scores stated as less than 11 or greater

than equal to 11 as this the cut point determined to be clinically relevant for stage group in AJCC8.

Oncotype DX Risk Level -Invasive, coded in NAACCR Data Item #3906, stratifies the Oncotype DX

recurrence score into three risk levels

Low risk: Recurrence Score result less than 18: The patient has a lower risk of having a

recurrence, assuming 5 years of hormonal therapy is given. Chemotherapy is likely to have little

or no benefit.

Intermediate Risk: Recurrence Score result between 18 and 30: The patient has a tumor that is

in the middle of the risk spectrum reflecting that biology is continuous and not all patients have

a low or a high recurrence risk, assuming 5 years of hormonal therapy is given. The likelihood of

distant recurrence and benefit from chemotherapy increases with an increase in the Recurrence

Score result.

High risk: Recurrence Score result greater than or equal to 31: The patient has a high risk of

distant recurrence, assuming 5 years of hormonal therapy and is likely to benefit from

chemotherapy.

Additional Information

Source documents: Oncotype Dx Breast Recurrence Score laboratory report, other statements

in medical record

For further information, see http://www.oncotypeiq.com/en-US/breast-cancer/healthcare-

professionals/oncotype-dx-breast-recurrence-score/about-the-test

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00480: Breast (2018+)

3903: Oncotype Dx Recurrence Score-DCIS

Item Length: 3

NAACCR Item #: 3903

XML Parent-NAACCR ID: Tumor-oncotypeDxRecurrenceScoreDcis

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Oncotype Dx Recurrence Score-DCIS is a numeric score of a genomic test to predict the likelihood of

distant recurrence of invasive breast cancer based on the assessment of 21 genes.

Rationale

Oncotype Dx Recurrence Score-DCIS is a Registry Data Collection Variable in AJCC. It is a new data item

for cases diagnosed 1/1/2018+.

See 3903-3906: Oncotype Dx Tests for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Oncotype Dx Recurrence Score-DCIS can be used to code this data item.

Note 2: The Oncotype Dx-DCIS recurrence score is reported as a whole number between 0 and 100.

Note 3: Record only the results of an Oncotype Dx-DCIS recurrence score in this data item. If some other

test is used for scoring, assign code XX9.

Note 4: In cases where Oncotype Dx-DCIS is reported on more than one in situ breast tumor specimen,

record the highest value.

Note 5: Code XX9 for LCIS tumors.

Note 6: If the only information available is the Oncotype Dx-DCIS Risk Level, assign XX7.

Note 7: Code this data item using the same report used to record 3905: Oncotype Dx Risk Level-DCIS.

Code Description

000-100 Enter actual recurrence score between 0 and 100

XX6 Not applicable: invasive case

XX7

Test

ordered

, results not in chart

XX8

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XX8 will result in an edit error.)

XX9

Not documented in medical record

Oncotype Dx Recurrence Score-DCIS not assessed or unknown if assessed

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00480: Breast (2018+)

3905: Oncotype Dx Risk Level-DCIS

Item Length: 1

NAACCR Item #: 3905

XML Parent-NAACCR ID: Tumor-oncotypeDxRiskLevelDcis

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Oncotype Dx Risk Level-DCIS stratifies Oncotype Dx recurrence scores into low, intermediate, and high

risk of local recurrence.

Rationale

Oncotype Dx Risk Level-DCIS is a Registry Data Collection Variable in AJCC. It is a new data item for cases

diagnosed 1/1/2018+.

See 3903-3906: Oncotype Dx Tests for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Oncotype Dx Risk Level-DCIS can be used to code this data item.

Note 2: The Oncotype Dx Risk Level-DCIS test stratifies scores into low, intermediate, and high risk of

distant recurrence. If only the score is stated, assign the risk level based on the score.

Note 3: Code 9 for LCIS tumors.

Note 4: Record only the results of an Oncotype Dx Risk Level-DCIS in this data item. If some other test is

used for scoring, assign code 9.

Note 5: Code this data item using the same report used to record 3903: Oncotype Dx Recurrence Score-

DCIS.

Code Description

0 Low risk (recurrence score 0-38)

1 Intermediate risk (recurrence score 39-54)

2 High risk (recurrence score greater than or equal to 55)

6 Not applicable: invasive case

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Oncotype Dx Risk Level-DCIS not assessed or unknown if assessed

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00480: Breast (2018+)

3904: Oncotype Dx Recurrence Score-Invasive

Item Length: 3

NAACCR Item #: 3904

XML Parent-NAACCR ID: Tumor-oncotypeDxRecurrenceScoreInvasiv

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Oncotype Dx Recurrence Score-Invasive is a numeric score of a genomic test to predict the likelihood of

distant recurrence of invasive breast cancer based on the assessment of 21 genes.

Rationale

Oncotype Dx Recurrence Score-Invasive is a Registry Data Collection Variable in AJCC. It is a new data

item for cases diagnosed 1/1/2018+.

See 3903-3906: Oncotype Dx Tests for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Oncotype Dx Recurrence Score-Invasive score can be used to code this

data item.

Note 2: The Oncotype Dx-Invasive recurrence score is reported as a whole number between 0 and 100.

The actual recurrence score takes priority over codes XX4 and XX5.

Note 3: Record only the results of an Oncotype Dx-Invasive recurrence score in this data item. If some

other test is used for scoring, assign code XX9.

Note 4: Predicted Oncotype Dx Recurrence Score based on linear regression models and Magee

equations should not be reported in this field.

If the only information you have on Oncotype Dx is based on a linear regression model and

Magee score, code unknown

Code the results of a Magee score in the Multigene Data Items: Multigene Signature Method

[NAACCR Data Item #3894] and Multigene Signature Results [NAACCR Data Item #3895]

Note 5: In cases where Oncotype DX is reported on more than one breast tumor specimen, record the

highest value.

Note 6: Results from nodal or metastatic tissue may be used ONLY when there is no evidence of primary

tumor.

Note 7: Staging for Breast cancer now depends on the Oncotype-Dx-Invasive recurrence score. Score of

less than 11 indicates a pertinent cut off value for staging purposes.

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Note 8: If the only information available is the Oncotype Dx-Invasive Risk Level, assign XX7.

Note 9: Code this data item using the same report used to record 3906: Oncotype Dx Risk Level-Invasive.

Code Description

000-100 Enter actual recurrence score between 0 and 100

XX4 Stated as less than 11

XX5 Stated as equal to or greater than 11

XX6 Not applicable: in situ case

XX7

Test

ordered

, results not in chart

XX9

Not documented in medical

record

Oncotype Dx Recurrence Score-Invasive not assessed or unknown if assessed

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00480: Breast (2018+)

3906: Oncotype Dx Risk Level-Invasive

Item Length: 1

NAACCR Item #: 3906

XML Parent-NAACCR ID: Tumor-oncotypeDxRiskLevelInvasive

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Oncotype Dx Risk Level-Invasive stratifies Oncotype Dx recurrence scores into low, intermediate, and

high risk of distant recurrence.

Rationale

Oncotype Dx Risk Level-Invasive is a Registry Data Collection Variable in AJCC. It is a new data item for

cases diagnosed 1/1/2018+.

See 3903-3906: Oncotype Dx Tests for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Oncotype Dx Risk Level-Invasive can be used to code this data item.

Note 2: The Oncotype Dx Risk Level-Invasive test stratifies scores into low, intermediate, and high risk of

distant recurrence. If only the score is stated, assign the risk level based on the score.

Note 3: Record only the results of an Oncotype Dx Risk Level-Invasive in this data item. If some other

test is used for scoring, assign code 9.

Note 4: Code this data item using the same report used to record 3904: Oncotype Dx Recurrence Score-

Invasive.

Code Description

0 Low risk (recurrence score 0-17)

1 Intermediate risk (recurrence score 18-30)

2 High risk (recurrence score greater than or equal to 31)

6 Not applicable: DCIS case

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Oncotype Dx Risk Level-Invasive not assessed or unknown if assessed

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00480: Breast (2018+)

3863: Ki-67

Item Length: 5

NAACCR Item #: 3863

XML Parent-NAACCR ID: Tumor-ki67

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

Ki-67 (MIB-1) (Proliferative Index) is a marker of cell proliferation. A high value indicates a tumor that is

proliferating more rapidly. Codes and coding instructions for this data item are site-specific.

Rationale

Ki-67 (MIB-1) (Proliferative Index) is a Registry Data Collection Variable in AJCC. It was a new data item

for breast cases diagnosed 1/1/2018+. It will apply to neuroendocrine tumors (NET) of the

gastrointestinal tract (AJCC Chapters 29 – 34) for cases diagnosed 1/1/2021+. High Ki-67 is an adverse

prognostic factor and Ki-67 is a component of grade for these tumors. NCCN guidelines recommend

that tumor differentiation, mitotic rate and Ki-67 should be recorded in the pathology report for these

tumors.

Coding Instructions

Note 1: Physician statement of Ki-67 (MIB-1) can be used to code this data item.

Note 2: Ki-67 is a marker of cell proliferation. A high value indicates a tumor that is proliferating more

rapidly.

Note 3: Results from nodal or metastatic tissue may be used, ONLY when there is no evidence of

primary tumor.

Note 4: Ki-67 results are reported as the percentage cell nuclei that stain positive. As of early 2017

there are no established standards for interpretation of results or for cutoffs for positive and negative.

Examples:

Ki-67 reported as 14%. Code 14.0

Ki-67 reported as 8.6%. Code 8.6

Note 5: In cases where there are invasive and in situ components in the primary tumor and Ki-67 is done

on both, ignore the in situ results.

If Ki-67 is done on both the in situ and invasive components in the primary tumor, code the Ki-

67 value from the invasive component

If in situ and invasive components present and Ki-67 only done on the in situ component in the

primary tumor, code unknown

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Code Description

0.0-100.0 0.0 to 100.0 percent positive: enter percent positive

XXX.7 Test done, actual percentage not stated

XXX.8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XXX.8 will result in an edit

error.)

XXX.9 Not documented in medical record

Ki-67 (MIB-1) not assessed or unknown if assessed

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00480: Breast (2018+)

3882: LN Positive Axillary Level I-II

Item Length: 2

NAACCR Item #: 3882

XML Parent-NAACCR ID: Tumor-lnPositiveAxillaryLevel1To2

NAACCR Alternate Name: Lymph Nodes Positive Axillary Level I-II

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

This data item pertains to the number of positive ipsilateral level I and II axillary lymph nodes and

intramammary lymph nodes based on pathological information.

Rationale

Lymph Nodes Positive Axillary Level I-II can be collected by the surveillance community for breast

cancers. Prior to 2018, Breast SSF#3 was used for Lymph Nodes Positive Axillary Level I-II.

Definition

This data items records the low axillary (level I and intramammary) and mid-axillary (level II, also called

interpectoral or Rotter’s nodes).

This data item excludes level III (high axillary, also called apical or infraclavicular), internal mammary and

supraclavicular lymph nodes.

Do not confuse intramammary nodes, which are within breast tissue and are included in level I, with

internal mammary nodes, which are along the sternum.

This field is based on pathological examination of ipsilateral (same side as the primary cancer) level I and

II axillary lymph nodes, so pathological information is included even if the patient had neoadjuvant

therapy prior to lymph node removal.

Do not include lymph nodes containing only isolated tumor cells (ITCs—metastases less than 0.2 mm in

size) in the count of positive nodes.

Coding guidelines

Code 00 when all level I and II axillary lymph nodes are negative on pathological examination

Code the exact number of lymph nodes in the range 01 to 99 for the exact count of level I and II

axillary lymph nodes, or X1 if more than 99 level I and II axillary lymph nodes are positive

Code X5 if level I and II axillary lymph nodes were positive, but the number is not specified

Code X6 if there was only a positive aspiration of level I or II axillary lymph node(s)

Code X9 when

o No axillary nodes were examined

o Axillary dissection was performed but no axillary lymph nodes were found

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o Clinical diagnosis only (no axillary lymph nodes were removed)

o Unknown whether axillary lymph nodes are positive

Additional information

Required for Staging: EOD only.

Source documents pathology report

Coding Instructions and Codes

Note 1: Physician statement of number of positive ipsilateral Level I-II axillary nodes can be used to code

this data item, when no other specific information is available.

Note 2: Include only the number of positive ipsilateral level I and II axillary lymph nodes and

intramammary lymph nodes in this field. Intramammary nodes, located within the breast, are not the

same as internal mammary nodes, located along the sternum.

Note 3: This field is based on microscopic information only. If no ipsilateral axillary nodes are examined,

or if an ipsilateral axillary lymph node drainage area is removed but no lymph nodes are found, code X9.

Note 4: For cases where neoadjuvant therapy is administered

If clinical nodal involvement is more extensive, include only those nodes that are positive during

clinical workup

o Positive nodes can be from an FNA, core biopsy or sentinel lymph node biopsy

Example: Patient with positive FNA of axillary lymph node, neoadjuvant therapy

administered. Lymph node dissection revealed negative lymph nodes. Code X6

for the positive FNA.

If the post-neoadjuvant nodal involvement is more extensive, include only those nodes positive

during surgery

o Positive nodes can be from an FNA, core biopsy, sentinel lymph node biopsy or lymph

node dissection

Example: Patient with large breast mass, lymph node negative on clinical exam.

Neoadjuvant therapy administered. Mastectomy and sentinel lymph node

biopsy done, 1 of 2 SLN’s positive. Code 01.

Note 5: Lymph nodes with only isolated tumor cells (ITCs) are not counted as positive lymph nodes.

Only lymph nodes with metastases greater than 0.2 mm (micrometastases or larger) should be counted

as positive. If the pathology report indicates that axillary nodes are positive, but size of the metastases is

not stated, assume the metastases are greater than 0.2 mm and code the lymph nodes as positive in this

field.

Note 6: When positive ipsilateral axillary lymph nodes are coded in this field, the number of positive

ipsilateral axillary lymph nodes must be less than or equal to the number coded in Regional Nodes

Positive (i.e., the number of positive ipsilateral axillary nodes will always be a subset of the number of

positive regional nodes.)

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Code Description

00 All ipsilateral axillary nodes examined negative

99 nodes positive

(Exact number of nodes positive)

X1 100 or more nodes positive

X5 Positive nodes, number unspecified

X6 Positive aspiration or needle core biopsy of lymph node(s)

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

Not documented in medical record

Level I-II axillary nodes not assessed or unknown if assessed

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00480: Breast (2018+)

3922: Response to Neoadjuvant Therapy

Item Length: 1

NAACCR Item #: 3922

XML Parent-NAACCR ID: Tumor-responseToNeoadjuvantTherapy

NAACCR Alternate Name: None

Active years: 2018+

Schemas(s):

00480: Breast (2018+)

Description

This data item records the physician’s statement of response to neoadjuvant chemotherapy.

Rationale

Response to Neoadjuvant Therapy is a Registry Data Collection Variable in AJCC. It was previously

collected as Breast, CS SSF #21.

Definition

Neoadjuvant therapy is defined as systemic or radiation treatment administered prior to surgery in an

attempt to shrink the tumor or destroy regional metastases. This data item documents whether that

neoadjuvant therapy was successful.

This data item is coded based on the clinician’s statement regarding response to neoadjuvant

therapy. Do not try to interpret or infer a response based on the medical record. As a guide for the

clinician, the definitions below are from the AJCC Cancer Staging Manual, 8

edition.

The registrar should not use these definitions to code this field

Complete Response (CR) – absence of invasive carcinoma in breast and lymph nodes; must be

determined by microscopic evaluation of tissues; residual in situ cancer at primary site

Partial Response (PR) – a decrease in T and/or N category compared to pretreatment value and

no increase, using same method of evaluation as baseline value; residual tumor in lymph nodes

of any size

No Response (NR) – no apparent change in the T or N category compared to pretreatment value,

or an increase in T or N value at time of y pathological examination

Coding guidelines

Code 0 if there is no neoadjuvant therapy given

o This includes in situ (behavior /2) cases

Code 1 for a Residual Cancer Burden (RCB) result of '0' or an RCB Class of pCR (pathological

complete response).

Code 9 when

o there is no statement of complete, partial or no response by the clinician or when the

response is not documented in the medical record

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Additional Information

For further information, refer to the Breast or Breast Biomarker Reporting cancer protocols

published by the College of American Pathologists for the AJCC Staging System Breast

Other names: treatment effect

Coding Instructions and Codes

Note 1: Clinician statement of Response to Neoadjuvant Therapy (“treatment effect”) must be used to

code this data item.

Note 2: The clinician’s statement may be based on pathology reports, imaging, and other clinical

findings.

Note 3: Code 1 is to be used only when the physician states the response is “total” or “complete.”

Code Description

Neoadjuvant therapy not given

Non-invasive neoplasm (behavior /2)

1 Stated as complete response (CR)

2 Stated as partial response (PR)

3 Stated as response to treatment, but not noted if complete or partial

4 Stated as no response (NR)

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit

error.)

9 Not documented in medical record

Response to neoadjuvant therapy not assessed or unknown if assessed

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FEMALE REPRODUCTIVE ORGANS

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3836: FIGO

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00500: Vulva (FIGO: Vulva) (2018+)

00510: Vagina (FIGO: Vagina) (2018+)

00520: Cervix Uteri (2018-2020) (FIGO: Cervix) (2018+)

09520: Cervix Uteri (2021+) (FIGO: Cervix) (2018+)

00528: Cervix Sarcoma (2021+) (FIGO Stage (Sarcoma)) (2018+)

00530: Carcinoma and Carcinosarcoma (FIGO: Corpus Carcinoma and Carcinosarcoma) (2018+)

00541: Corpus Sarcoma (FIGO Stage (Adenosarcoma) (2018+)

00542: Corpus Adenosarcoma (FIGO Stage (Sarcoma)) (2018+)

00551: Ovary (FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma) (2018+)

00552: Primary Peritoneal Carcinoma (FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma)

(2018+)

00553: Fallopian Tube (FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma) (2018+)

00560: Placenta (FIGO: Gestational Trophoblastic Tumors (Placenta)) (2018+)

Description

Federation Internationale de Gynecologie et d'Obstetrique (FIGO) is a staging system for female

reproductive cancers.

Rationale

FIGO stage is a Registry Data Collection Variable in AJCC for the female genital cancers. This data item

was previously collected for the female genital cancers as: Vulva SSF #10, Vagina SSF #1, Cervix SSF #1,

Corpus Carcinoma SSF #1, Corpus Sarcoma SSF #1, Ovary SSF #2, Fallopian Tube SSF #1, Peritoneum

Female Genital SSF #1, and Placenta SSF #2.

Definition

FIGO is the French acronym for the Federation Internationale de Gynecologie et d’Obstetrique, the

worldwide organization of obstetricians and gynecologists who maintain the international staging

systems for female genital organs. In English, the organization is the International Federation of

Gynecology and Obstetrics. The FIGO staging system has been adapted into the AJCC staging

manual. FIGO uses Roman numerals and subscripts to define a stage. There is no T, N, or M descriptor

with FIGO stage, only a stage group. For example, FIGO Stage IA is equivalent to T1a, FIGO Stage III can

be either T3_ or N1, and FIGO Stage IV is M1.

Definitions of the various FIGO stages vary from primary to primary, but the structure is similar

throughout. FIGO no longer includes an in situ stage (Tis, Stage 0). For in situ tumors, code the following

Code 97: Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

Note: Do not confuse FIGO stage with FIGO grade.

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Structure of Codes

For all sites, the structure of the FIGO data items is the same, although not every system uses every

possible FIGO code and the actual codes used are not the same for all systems.

Coding guidelines

Code the FIGO stage as stated in the medical record. When lymph node(s) is/are clinically or

pathologically positive or metastasis is present, make sure that the FIGO stage reflects the combination

of T, N, and M and NOT just the T. If a stage group is stated but it does not specify that it is a FIGO stage,

assume that it is a FIGO stage and code it. Do not attempt to code FIGO stage based only on T, N, and M.

If you cannot make a determination of stage based on the previous information, code 99.

1 FIGO Stage I (all systems)

1B2 FIGO Stage IB2 (cervix only)

2 FIGO Stage II (all systems)

3A12 FIGO Stage IIIA1ii (ovary, fallopian tube, and primary peritoneal carcinoma only)

4 FIGO Stage IV (all systems)

99: FIGO Stage unknown, FIGO stage not assessed or unknown if FIGO stage assessed

Additional Information

Source documents: clinician’s notes, consultant notes, pathology report, radiation therapy

notes

FIGO Stage: Summary of Schemas

Code Description Vulva

Vagina Cervix Corpus

Sarcoma

Corpus

Adeno-

Sarcoma

Corpus

Carcinoma

Ovary,

FT, PPC

Placenta

1 FIGO Stage I X X X X X X X* X

1A FIGO Stage IA X X X X X X*

1A1 FIGO Stage IA1 X

1A2 FIGO Stage IA2 X

1B FIGO Stage IB X X X X X X*

1B1 FIGO Stage IB1 X

1B2 FIGO Stage IB2 X

1B3 FIGO Stage IB3 X**

1C FIGO Stage IC X X*

1C1 FIGO Stage IC1 X*

1C2 FIGO Stage IC2 X*

1C3

FIGO Stage IC3

FIGO Stage II

2A FIGO Stage IIA X X X X

2A1 FIGO Stage IIA1 X

2A2 FIGO Stage IIA2 X

2B FIGO Stage IIB X X X

3 FIGO Stage III X X X X X X X X

3A FIGO Stage IIIA X X X X X X

3A1 FIGO Stage IIIA1 X

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Code Description Vulva

Vagina Cervix Corpus

Sarcoma

Corpus

Adeno-

Sarcoma

Corpus

Carcinoma

Ovary,

FT, PPC

Placenta

3A11 FIGO Stage IIIA1i X

3A12 FIGO Stage IIIA1ii X

3A2 FIGO Stage IIIA2 X

3B FIGO Stage IIIB X X X X X X

3C FIGO Stage IIIC X X X X X X

3C1 FIGO Stage IIIC1 X** X

3C2 FIGO Stage IIIC2 X** X

4 FIGO Stage IV X X X X X X X X

FIGO Stage IVA

4B FIGO Stage IVB X X X X X X X

*Not applicable for Primary Peritoneal Carcinoma

** Cervix Version 9 only (effective 1/1/2021 forward)

In addition to the codes listed above, the following codes are also applicable

Code

Description

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)*

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

*Not applicable for the Cervix Sarcoma, Corpus Adenosarcoma, and Corpus Sarcoma

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Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN

Sites

Definition

In addition to assigning the N categories for cervix, vagina and vulva cancers, the collection of specific

lymph nodes and how they were assessed is important.

Status refers to positive or negative involvement

Assessment is the method by which the nodal status was determined

There are 6 data items that collect information on regional lymph nodes. Three data items collect the

individual status (positive, negative, unknown) involvement of femoral-inguinal, para-aortic and pelvic

lymph nodes. There are 3 assessment data items that collect individual status information on the 3

regional lymph node groups.

3871: LN Assessment Method Femoral-Inguinal

3872: LN Assessment Method Para-Aortic

3873: LN Assessment Method Pelvic

3957: LN Status: Pelvic

3958: LN Status: Para-Aortic

3959: LN Status: Femoral-Inguinal

There are 2 data items that collect information on distant lymph nodes. One data item collects the

status (positive, negative, unknown) involvement of mediastinal and scalene distant lymph nodes. The

other data item collects the assessment method.

3874: LN Distant Assessment Method

3875: LN Distant: Mediastinal, Scalene

For the 4 status fields, the data items have a basic set up

Code 0 when all lymph nodes are negative

Multiple codes are available to record single or multiple involvement of lymph nodes

Code 9 when

o Not documented in medical record

o Regional/Distant lymph nodes not evaluated (assessed)

o Unknown if regional/distant lymph nodes evaluated (assessed)

For the 4 methods fields, the codes are the same

Code 0 when there is physical exam or imaging only

Code 1 when there is an incisional biopsy or FNA

Code 2 when there is an excisional biopsy or lymph node resection

Code 7 when lymph nodes are assessed, but it is unknown how

Code 9 when

o Not documented in medical record

o Regional/Distant lymph nodes not evaluated (assessed)

o Unknown if regional/distant lymph nodes evaluated (assessed)

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00500: Vulva (2018+)

3836: FIGO: Vulva

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Note 4: The FIGO stage definitions do not include Stage 0 (Tis).

Code 97 for any non-invasive neoplasm (behavior /2)

Code Description

1 FIGO Stage I

1A FIGO Stage IA

1B FIGO Stage IB

2 FIGO Stage II

FIGO Stage III

FIGO Stage IIIA

3B FIGO Stage IIIB

3C FIGO Stage IIIC

4 FIGO Stage IV

4A FIGO Stage IVA

4B FIGO Stage IVB

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

Not documented in medical

record

FIGO stage unknown, not assessed or unknown if assessed

Return to Schema ID Table

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00500: Vulva (2018+)

3959: LN Status: Femoral-Inguinal

Item Length: 1

NAACCR Item #: 3959

XML Parent-NAACCR ID: Tumor-lnStatusFemoralInguinal

NAACCR Alternate Name: Lymph Nodes Status: Femoral-Inguinal

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

Description

This data item describes the status of femoral-inguinal lymph nodes associated with certain female

genital cancers.

Rationale

Specific regional lymph node involvement is listed as a Registry Data Collection Variable in AJCC. This

information was previously collected as Vulva, SSF #14

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of the femoral-inguinal status can be used to code this data item when no

other information is available.

Note 2: The following are femoral-inguinal nodes

Femoral

Inguinal, NOS

o Inguinofemoral (groin)

o Node of Cloquet or Rosenmuller (highest deep inguinal)

o Superficial inguinal

Note 3: If there is no mention of femoral-inguinal lymph node involvement in the area being imaged,

biopsied, or in the surgical field and there is no mention of involvement, then assume that the femoral-

inguinal lymph nodes are negative.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Code 9 when there is no imaging, biopsy, surgical workup, or a physical exam only.

Note 6: The assessment method is recorded in 3871: LN Assessment Method Femoral-Inguinal.

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Code Description

0 Negative femoral-inguinal lymph nodes

Non-invasive neoplasm (behavior /2)

1 Positive femoral-inguinal lymph nodes

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Femoral-Inguinal lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00500: Vulva (2018+)

3871: LN Assessment Method Femoral-Inguinal

Item Length: 1

NAACCR Item #: 3871

XML Parent-NAACCR ID: Tumor-lnAssessMethodFemoralInguinal

NAACCR Alternate Name: Lymph Nodes Assessment Method Femoral-Inguinal

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

0510: Vagina (2018+)

Description

This data item describes the method used to assess involvement of femoral-inguinal lymph nodes

associated with certain female genital cancers.

Rationale

Method of assessment of regional nodal status is listed as a Registry Data Collection Variable in the AJCC

GYN chapters. This data item was previously collected as Vulva, SSF #15.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of femoral-inguinal assessment method can be used to code this data item

when no other information is available.

Note 2: The following are femoral-inguinal nodes

Femoral

Inguinal, NOS

o Inguinofemoral (groin)

o Node of Cloquet or Rosenmuller (highest deep inguinal)

o Superficial inguinal

Note 3: Assign the highest applicable code (0-2) in the case of multiple assessments.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Code 0 when there is only imaging or a physical exam.

Note 6: The status results are recorded in 3959: LN Status: Femoral-Inguinal.

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Code Description

0 Radiography, imaging

(Ultrasound (US), computed tomography scan (CT), magnetic resonance imaging (MRI),

positron emission tomography scan (PET))

Physical exam only

1 Incisional biopsy; fine needle aspiration (FNA)

2 Lymphadenectomy

Sentinel node biopsy

Excisional biopsy or resection with microscopic confirmation

7 Femoral-inguinal lymph node(s) assessed, unknown assessment method

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not

documented in medical record

Femoral-inguinal lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00500: Vulva (2018+)

3957: LN Status: Pelvic

Item Length: 1

NAACCR Item #: 3957

XML Parent-NAACCR ID: Tumor-lnStatusPelvic

NAACCR Alternate Name: Lymph Node Status: Pelvic

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the status of pelvic lymph nodes associated with certain female genital cancers.

Rationale

Specific regional lymph node involvement is listed as a Registry Data Collection Variable in AJCC. This

information was previously collected as Vulva, SSF #12

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding instructions and Codes

Note 1: Physician statement of pelvic status can be used to code this data item when no other

information is available.

Note 2: For Vulva, pelvic lymph nodes are distant.

Note 3: The following are pelvic nodes

Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

Paracervical

Parametrial

Pelvic, NOS

Sacral, NOS

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Uterosacral

Note 4: If there is no mention of pelvic lymph node involvement in the area being imaged, biopsied, or

in the surgical field and there is no mention of involvement, then assume that the pelvic lymph nodes

are negative.

Note 5: For this data item, do not include isolated tumor cells (ITCs).

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Note 6: Code 9 when there is no imaging, biopsy, surgical workup, or a physical exam only.

Note 7: The assessment method is recorded in 3873: LN Assessment Method Pelvic.

Code Description

0 Negative pelvic lymph nodes

Non-invasive neoplasm (behavior /2)

1 Positive pelvic lymph nodes

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter,

use of code 8 may result in an edit error.)

9 Not documented in medical record

Pelvic lymph node(s) not assessed or unknown if

assessed

Return to Schema ID Table

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00500: Vulva (2018+)

3873: LN Assessment Method Pelvic

NAACCR Item #: 3873

XML Parent-NAACCR ID: Tumor-lnAssessMethodPelvic

NAACCR Alternate Name: Lymph Nodes Assessment Method Pelvic

Active years: 2018+

Schemas(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the method used to assess involvement of pelvic lymph nodes associated with

certain female genital cancers.

Rationale

Method of assessment of regional nodal status is listed as a Registry Data Collection Variable in the AJCC

GYN chapters. This data item was previously collected as Vulva, SSF #13.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of pelvic assessment method can be used to code this data item when no

other information is available.

Note 2: For Vulva, pelvic lymph nodes are distant.

Note 3: The following are pelvic nodes

Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

Paracervical

Parametrial

Pelvic, NOS

Sacral, NOS

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Uterosacral

Note 4: Assign the highest applicable code (0-2) in the case of multiple assessments.

Note 5: For this data item, do not include isolated tumor cells (ITCs).

Note 6: Code 0 when there is only imaging or a physical exam.

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Note 7: The assessment results are recorded in 3957: LN Status: Pelvic.

Code Description

Radiography, imaging

(Ultrasound (US), computed tomography scan (CT), magnetic resonance imaging (MRI),

positron emission tomography scan (PET))

Physical exam only

1 Incisional biopsy; fine needle aspiration (FNA)

2 Lymphadenectomy

Sentinel node biopsy

Excisional biopsy or resection with microscopic confirmation

7 Pelvic lymph node(s) assessed, unknown assessment method

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Pelvic lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00500: Vulva (2018+)

3881: LN Laterality

Item Length: 1

NAACCR Item #: 3881

XML Parent-NAACCR ID: Tumor-lnLaterality

NAACCR Alternate Name: Lymph Nodes Laterality

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

Description

This data item describes whether positive regional lymph nodes are unilateral or bilateral.

Rationale

Laterality of regional node metastasis is a Registry Data Collection Variable in AJCC. This data item was

previously collected as Vulva, CS SSF #11.

Definition

This data item records the appropriate description of involved regional lymph nodes, specifically

whether they are unilateral or bilateral involvement.

Coding guidelines

Code the appropriate description of involved regional lymph nodes

Code 0 when all regional lymph nodes are negative

Code 1 when

o all positive regional nodes are ipsilateral

o involved lymph nodes are described as unilateral

Code 2 when

o at least one regional lymph node is involved on each side of the pelvis

o involvement is described as bilateral or contralateral

Code 3 when regional lymph node(s) are described as positive but the laterality of the involved

nodes is unknown

Code 9 when

o Lymph nodes were not examined or assessed

o there is no information in the medical record about regional lymph node involvement

o the status of regional lymph nodes is unknown

Additional Information

Source documents: pathology report, imaging, physical exam, other statement in record

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Coding Instructions and Codes

Note: Physician statement of lymph node laterality can be used to code this data item when no other

information is available.

Code Description

0 No regional lymph node involvement

Non-invasive neoplasm (behavior /2)

1 Unilateral - all positive regional nodes with same laterality

OR only one regional node positive

2 Bilateral - positive bilateral regional lymph nodes

3 Laterality unknown - positive regional lymph nodes with unknown laterality

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Lymph node laterality not assessed or unknown if assessed

Return to Schema ID Table

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00510: Vagina (2018+)

3836: FIGO: Vagina

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00510: Vagina (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Note 4: The FIGO stage definitions do not include Stage 0 (Tis).

Code 97 for any non-invasive neoplasm (behavior /2)

Code Description

1 FIGO Stage I

2 FIGO Stage II

3 FIGO Stage III

4 FIGO Stage IV

FIGO Stage IVA

FIGO Stage IVB

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

Return to Schema ID Table

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00510: Vagina (2018+)

3959: LN Status: Femoral-Inguinal

Item Length: 1

NAACCR Item #: 3959

XML Parent-NAACCR ID: Tumor-lnStatusFemoralInguinal

NAACCR Alternate Name: Lymph Nodes Status: Femoral-Inguinal

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

Description

This data item describes the status of femoral-inguinal lymph nodes associated with certain female

genital cancers.

Rationale

Specific regional lymph node involvement is listed as a Registry Data Collection Variable in AJCC. This

information was previously collected as Vulva, SSF #14

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of the femoral-inguinal status can be used to code this data item when no

other information is available.

Note 2: Code this data item for the lower third of the vagina only.

Code 9 for upper two thirds of the vagina, or unknown whether it’s the lower third or upper two

thirds

Note 3: The following are femoral-inguinal nodes

Femoral

Inguinal, NOS

o Inguinofemoral (groin)

o Node of Cloquet or Rosenmuller (highest deep inguinal)

o Superficial inguinal

Note 4: If there is no mention of femoral-inguinal lymph node involvement in the area being imaged,

biopsied, or in the surgical field and there is no mention of involvement, then assume that the femoral-

inguinal lymph nodes are negative.

Note 5: For this data item, do not include isolated tumor cells (ITCs).

Note 6: Code 9 when there is no imaging, biopsy, surgical workup, or a physical exam only.

Note 7: The assessment method is recorded in 3871: LN Assessment Method Femoral-Inguinal.

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Code Description

0 Negative femoral-inguinal lymph nodes

Non-invasive neoplasm (behavior /2)

1 Positive femoral-inguinal lymph nodes

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Femoral-Inguinal lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00500: Vagina (2018+)

3871: LN Assessment Method Femoral-Inguinal

Item Length: 1

NAACCR Item #: 3871

XML Parent-NAACCR ID: Tumor-lnAssessMethodFemoralInguinal

NAACCR Alternate Name: Lymph Nodes Assessment Method Femoral-Inguinal

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

Description

This data item describes the method used to assess involvement of femoral-inguinal lymph nodes

associated with certain female genital cancers.

Rationale

Method of assessment of regional nodal status is listed as a Registry Data Collection Variable in the AJCC

GYN chapters. This data item was previously collected as Vulva, SSF #15.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of femoral-inguinal assessment method can be used to code this data item

when no other information is available.

Note 2: The following are femoral-inguinal nodes

Femoral

Inguinal, NOS

o Inguinofemoral (groin)

o Node of Cloquet or Rosenmuller (highest deep inguinal)

o Superficial inguinal

Note 3: Code this data item for the lower third of the vagina only.

Code 9 for upper two thirds of the vagina, or unknown whether it’s the lower third or upper two

thirds

Note 4: Assign the highest applicable code (0-2) in the case of multiple assessments.

Note 5: For this data item, do not include isolated tumor cells (ITCs).

Note 6: Code 0 when there is only imaging or a physical exam.

Note 7: The status results are recorded in 3959: LN Status: Femoral-Inguinal.

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Code Description

0 Radiography, imaging

(Ultrasound (US), computed tomography scan (CT), magnetic resonance imaging (MRI),

positron emission tomography scan (PET))

Physical exam only

1 Incisional biopsy; fine needle aspiration (FNA)

2 Lymphadenectomy

Sentinel node biopsy

Excisional biopsy or resection with microscopic confirmation

7 Femoral-inguinal lymph node(s) assessed, unknown assessment method

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Femoral-inguinal lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00510: Vagina (2018+)

3958: LN Status: Para-Aortic

Item Length: 1

NAACCR Item #: 3958

XML Parent-NAACCR ID: Tumor-lnStatusParaAortic

NAACCR Alternate Name: Lymph Node Status: Para-aortic

Active years: 2018+

Schema(s):

00510: Vagina (2018+)

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the status of para-aortic lymph nodes associated with certain female genital

cancers.

Rationale

Specific regional lymph node involvement is listed as a Registry Data Collection Variable in AJCC. This

information was previously collected as Vagina SSF #4

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of para-aortic status can be used to code this data item when no other

information is available.

Note 2: The following are para-aortic nodes

Aortic

Lateral aortic/lumbar aortic

Para-aortic, NOS

Periaortic

Note 3: If there is no mention of para-aortic lymph node involvement in the area being imaged,

biopsied, or in the surgical field and there is no mention of involvement, then assume that the para-

aortic lymph nodes are negative.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Code 9 when there is no imaging, biopsy, surgical workup, or a physical exam only.

Note 6: The assessment method is recorded in 3872: LN Assessment Method Para-Aortic.

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Code

Description

0 Negative para-aortic lymph nodes

Non-invasive neoplasm (behavior /2)

1 Positive para-aortic lymph nodes

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter,

use of code 8 may result in an edit error.)

9 Not documented in medical record

Para-aortic lymph node(s) not assessed or unknown if

assessed

Return to Schema ID Table

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00510: Vagina (2018+)

3872: LN Assessment Method Para-Aortic

Item Length: 1

NAACCR Item #: 3872

XML Parent-NAACCR ID: Tumor-lnAssessMethodParaaortic

NAACCR Alternate Name: Lymph Nodes Assessment Method Para-aortic

Active years: 2018+

Schema(s):

00510: Vagina (2018+)

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the method used to assess involvement of para-aortic lymph nodes associated

with certain female genital cancers.

Rationale

Method of assessment of regional nodal status is listed as a Registry Data Collection Variable in the AJCC

GYN chapters. This data item was previously collected as Vagina, CS SSF #5.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of para-aortic assessment of nodal status for para-aortic nodes can be used

to code this data item when no other information is available.

Note 2: The following are para-aortic nodes

Aortic

Lateral aortic/lumbar aortic

Para-aortic, NOS

Periaortic

Note 3: Assign the highest applicable code (0-2) in the case of multiple assessments.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Code 0 when there is only imaging or a physical exam.

Note 6: The assessment results are recorded in 3958: LN Status: Para-Aortic.

Code Description

Radiography, imaging

(Ultrasound (US), computed tomography scan (CT), magnetic resonance imaging (MRI),

positron emission tomography scan (PET))

Physical exam only

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Code Description

1 Incisional biopsy; fine needle aspiration (FNA)

2 Lymphadenectomy

Sentinel node biopsy

Excisional biopsy or resection with microscopic confirmation

7 Para-aortic lymph node(s) assessed, unknown assessment method

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Para-aortic lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00510: Vagina

3957: LN Status: Pelvic

Item Length: 1

NAACCR Item #: 3957

XML Parent-NAACCR ID: Tumor-lnStatusPelvic

NAACCR Alternate Name: Lymph Node Status: Pelvic

Active years: 2018+

Schema(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the status of pelvic lymph nodes associated with certain female genital cancers.

Rationale

Specific regional lymph node involvement is listed as a Registry Data Collection Variable in AJCC. This

information was previously collected as Vulva, SSF #12

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding instructions and Codes

Note 1: Physician statement of pelvic status can be used to code this data item when no other

information is available.

Note 2: The following are pelvic nodes

Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

Paracervical

Parametrial

Pelvic, NOS

Sacral, NOS

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Uterosacral

Note 3: If there is no mention of pelvic lymph node involvement in the area being imaged, biopsied, or

in the surgical field and there is no mention of involvement, then assume that the pelvic lymph nodes

are negative.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Code 9 when there is no imaging, biopsy, surgical workup, or a physical exam only.

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Note 6: The assessment method is recorded in 3873: LN Assessment Method Pelvic.

Code Description

0 Negative pelvic lymph nodes

Non-invasive neoplasm (behavior /2)

1 Positive pelvic lymph nodes

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter,

use of code 8 may result in an edit error.)

9 Not documented in medical record

Pelvic lymph node(s) not assessed or unknown if

assessed

Return to Schema ID Table

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00510: Vagina (2018+)

3873: LN Assessment Method Pelvic

NAACCR Item #: 3873

XML Parent-NAACCR ID: Tumor-lnAssessMethodPelvic

NAACCR Alternate Name: Lymph Nodes Assessment Method Pelvic

Active years: 2018+

Schemas(s):

00500: Vulva (2018+)

00510: Vagina (2018+)

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the method used to assess involvement of pelvic lymph nodes associated with

certain female genital cancers.

Rationale

Method of assessment of regional nodal status is listed as a Registry Data Collection Variable in the AJCC

GYN chapters. This data item was previously collected as Vulva, SSF #13.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of pelvic assessment method can be used to code this data item when no

other information is available.

Note 2: The following are pelvic nodes

Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

Paracervical

Parametrial

Pelvic, NOS

Sacral, NOS

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Uterosacral

Note 3: Assign the highest applicable code (0-2) in the case of multiple assessments.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Code 0 when there is only imaging or a physical exam.

Note 6: The assessment results are recorded in 3957: LN Status: Pelvic.

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Code Description

0 Radiography, imaging

(Ultrasound (US), computed tomography scan (CT), magnetic resonance imaging (MRI),

positron emission tomography scan (PET))

Physical exam only

1 Incisional biopsy; fine needle aspiration (FNA)

2 Lymphadenectomy

Sentinel node biopsy

Excisional biopsy or resection with microscopic confirmation

7 Pelvic lymph node(s) assessed, unknown assessment method

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Pelvic lymph node(s) not assessed or unknown if assessed

Return to Schema ID Table

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00510: Vagina (2018+)

3875: LN Distant: Mediastinal, Scalene

Item Length: 1

NAACCR Item #: 3875

XML Parent-NAACCR ID: Tumor-lnDistantMediastinalScalene

NAACCR Alternate Name: Lymph Nodes Distant: Mediastinal, Scalene

Active years: 2018+

Schema(s):

00510: Vagina

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the status of Distant (mediastinal, scalene) nodes associated with certain

female genital cancers.

Rationale

Specific distant lymph node involvement is listed as a Registry Data Collection Variable in the AJCC. This

data was previously collected as Vagina, CS SSF #6.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of mediastinal and scalene nodal status can be used to code this data item

when no other information is available.

Note 2: Assign the highest applicable code (1-3) in the case of positive nodes.

Note 3: If a nodal station is in the area being imaged, biopsied, or in the surgical field and there is no

mention of involvement, then assume that specific nodal station is negative.

Note 4: Code 9 when there is no imaging, biopsy, surgical workup, or a physical exam only.

Note 5: The assessment method is recorded in 3874: LN Distant Assessment Method.

Code Description

0 Negative mediastinal and scalene lymph nodes

Non-invasive neoplasm (behavior /2)

1 Positive mediastinal lymph nodes

2 Positive scalene lymph nodes

3 Positive mediastinal and scalene lymph nodes

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Mediastinal and scalene lymph nodes not assessed or unknown if assessed

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00510: Vagina

3874: LN Distant Assessment Method

Item Length: 1

NAACCR Item #: 3874

XML Parent-NAACCR ID: Tumor-lnDistantAssessMethod

NAACCR Alternate Name: Lymph Nodes Distant Assessment Method

Active years: 2018+

Schema(s):

00510: Vagina

00520: Cervix (2018-2020)

09520: Cervix (2021+)

Description

This data item describes the method used to assess involvement of Distant (mediastinal, scalene) nodes

associated with certain female genital cancers.

Rationale

Method of assessment of distant nodal status is listed as a Registry Data Collection Variable in the AJCC

GYN chapters. This data item was previously collected as Vagina, CS SSF #7.

See Lymph Node Assessment Methods and Status for Regional and Distant Lymph Nodes in GYN Sites

for additional information

Coding Instructions and Codes

Note 1: Physician statement of Mediastinal and Scalene assessment method can be used to code this

data item when no other information is available.

Note 2: Assign the highest applicable code (0-2) in the case of multiple assessments.

Note 3: Code 0 when there is only imaging or a physical exam.

Note 4: The assessment results are recorded in 3875: LN Distant: Mediastinal, Scalene.

Code Description

0 Radiography, imaging

(Ultrasound (US), computed tomography scan (CT), magnetic resonance imaging (MRI),

positron emission tomography scan (PET))

Physical exam only

1 Incisional biopsy; fine needle aspiration (FNA)

2 Lymphadenectomy

Excisional biopsy or resection with microscopic confirmation

7 Distant lymph node(s) assessed, unknown assessment method

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Distant lymph node(s) not assessed or unknown if assessed

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00520: Cervix (2018-2020)

See 00510: Vagina (2018+)

3958: LN Status: Para-Aortic

3872: LN Assessment Method Para-Aortic

3957: LN Status: Pelvic

3873: LN Assessment Method Pelvic

3874: LN Distant Assessment Method

3875: LN Distant: Mediastinal, Scalene

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00520: Cervix (2018-2020)

3836: FIGO: Cervix

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00520: Cervix (2018-2020)

009520: Cervix (2021+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Note 4: The FIGO stage definitions do not include Stage 0 (Tis).

Code 97 for any non-invasive neoplasm (behavior /2)

Code Description

1 FIGO Stage I

1A FIGO Stage IA

1A1

FIGO Stage

IA1

1A2

FIGO Stage IA2

1B FIGO Stage IB

1B1 FIGO Stage IB1

1B2 FIGO Stage IB2

1B3 FIGO Stage IB3

2 FIGO Stage II

2A FIGO Stage IIA

2A1 FIGO Stage IIA1

2A2 FIGO Stage IIA2

2B FIGO Stage IIB

3 FIGO Stage III

3A FIGO Stage IIIA

3B FIGO Stage IIIB

3C FIGO Stage IIIC

3C1 FIGO Stage IIIC1

3C2

FIGO Stage IIIC2

FIGO Stage IV

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Code Description

4A FIGO Stage IVA

4B FIGO Stage IVB

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

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09520: Cervix (2021+)

See 00510: Vagina (2018+)

3958: LN Status: Para-Aortic

3872: LN Assessment Method Para-Aortic

3957: LN Status: Pelvic

3873: LN Assessment Method Pelvic

3874: LN Distant Assessment Method

3875: LN Distant: Mediastinal, Scalene

See 00520: Cervix (2018-2020)

3836: FIGO: Cervix

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09520: Cervix (2021+)

3956: p16

Item Length: 1

NAACCR Item #: 3956

XML Parent-NAACCR ID: Tumor-p16

NAACCR Alternate Name: None

Active years: 2021+

Schema(s):

09520: Cervix (2021+)

09210: Anus (2023+)

Description

The p16 biomarker is overexpressed (produced) in response to HPV. It is therefore a surrogate marker

for HPV disease.

Rationale

Patients with HPV have a different survival or outcome so it is important to be able to distinguish this by

documenting the p16 results. Testing is performed by immunohistochemistry (IHC) which is inexpensive

and has near universal availability. It has an easily standardized interpretation. HPV testing is usually

performed through DNA testing which is more expensive and less widely available. HPV testing also has

technically more variability with the interpretation.

Definition

p16 is a tumor suppressor protein also known as cyclin-dependent kinase inhibitor 2A. The p16

biomarker is overexpressed (produced) in response to HPV. It is therefore a surrogate marker for HPV

disease.

Coding Instructions and Codes

Note 1: This SSDI is effective for diagnosis years 2021+.

For cases diagnosed 2018-2020, leave this SSDI blank

Note 2: Code 0 for p16 expression of weak intensity or limited distribution.

Note 3: This data item must be based on testing results for p16 overexpression.

A statement of a patient being HPV positive or negative is not enough to code this data item

Testing for HPV by DNA, mRNA, antibody, or other methods should not be coded in this data

item

Do not confuse p16 with HPV 16, which is a specific strain of virus

Code Description

0 p16 Negative; Nonreactive

1 p16 Positive; Diffuse, Strong reactivity

8 Not applicable: Information not collected for this case

(If this time is required by your standard setter, use of code 8 will result in an edit

error)

9 Not tested for p16; Unknown

<Blank> N/A-Diagnosis year prior to 2021

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00528: Cervix Sarcoma

See 00541: Corpus Sarcoma (2018+)

3836: FIGO Stage (Sarcoma)

See 00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3901: Number of Positive Para-Aortic Nodes

3899: Number of Examined Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3900: Number of Examined Pelvic Nodes

3911: Peritoneal Cytology

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00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3836: FIGO: Corpus Carcinoma and Carcinosarcoma

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00530: Corpus Carcinoma and Carcinosarcoma (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Note 4: For Endometrial intraepithelial carcinoma (EIC) (8380/2) and Serous endometrial intraepithelial

carcinoma (SEIC) (8441/2), assign the FIGO staged based on the managing physician's documentation of

FIGO. (See Note 1).

If FIGO stage for EIC or SEIC is not documented by the managing physician, code unknown (code

99)

Do not code 97 (in situ) for EIC or SEIC since FIGO does not have a Stage 0

If diagnosis is Endometrial intraepithelial neoplasia (EIN) (8380/2), code 97.

Note 5: Code 97 for any remaining in situ histologies (/2) since the FIGO stage definitions do not include

Stage 0.

Code Description

1 FIGO Stage I

1A FIGO Stage IA

1B FIGO Stage IB

2 FIGO Stage II

3 FIGO Stage III

FIGO Stage IIIA

FIGO Stage IIIB

3C FIGO Stage IIIC

3C1 FIGO Stage IIIC1

3C2 FIGO Stage IIIC2

4 FIGO Stage IV

4A FIGO Stage IVA

4B FIGO Stage IVB

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Code Description

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

Not

applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

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00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3899-3902: Number of Positive and Examined Para-Aortic and Pelvic Nodes

Definition

Involvement of regional and distant lymph nodes is an important prognostic factor for cancers of the

gynecologic organs. The following list shows the regional and common distant lymph nodes for GYN

cancers.

Para-aortic nodes

Aortic

Lateral aortic/lumbar aortic

Para-aortic, NOS

Periaortic

Pelvic nodes

Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

Paracervical

Parametrial

Pelvis, NOS

Sacral

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Presacral

o Uterosacral

For the Cervix sarcoma cases, there are 4 data items that record information on the number of

positive and examined para-aortic and pelvic lymph nodes. These data items should be coded from

the same procedure

3899: Number of Examined Para-Aortic Nodes

3900: Number of Examined Pelvic Nodes

3901: Number of Positive Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

Number of nodes positive must ALWAYS be less than or equal to number of nodes examined.

Additional Information

Source documents: pathology report

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00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3901: Number of Positive Para-Aortic Nodes

Item Length: 2

NAACCR Item #: 3901

XML Parent-NAACCR ID: Tumor-numberOfPositiveParaAorticNodes

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00528: Cervical Sarcoma (2021+)

00530: Corpus Carcinoma and Carcinosarcoma

00541: Corpus Sarcoma

00542: Corpus Adenosarcoma

Description

Number of Positive Para-Aortic Nodes is the number of positive nodes based on para-aortic nodal

dissection.

Rationale

Number of Positive Para-Aortic Nodes is listed as a Registry Data Collection Variable in AJCC. This data

item was previously collected as Corpus, CS SSF #5.

Coding guidelines

Code 00 for when there are no positive nodes

Code the exact number of positive nodes 01-99

Code X1 for 100 or more positive nodes

Code X2 for positive nodes, but unknown how many

Code X6 for aspiration or core biopsy of para-aortic node(s) only

Code X9 when

o Not documented in the medical record

o Para-Aortic lymph nodes not evaluated (assessed)

o No lymph node dissection performed

o Unknown if Para-Aortic lymph nodes evaluated (assessed)

See 3899-3902: Number of Positive and Examined Para-Aortic and Pelvic Nodes for additional

information

Coding Instructions and Codes

Note 1: Physician statement of positive para-aortic nodes can be used to code this data item when no

other information is available.

Note 2: The following are para-aortic nodes

Aortic

Lateral aortic/lateral lumbar

Para-aortic, NOS

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Periaortic

Note 3: Record the number of positive para-aortic lymph nodes documented in the medical record.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Micrometastasis and macrometastasis may be listed separately on the pathology report. Add

these two together to get the total number of positive nodes.

Note 6: Code X9 if no lymph node dissection is performed.

If only a FNA or core biopsy is done and it is positive, then code X6

If only a FNA or core biopsy is done and it is negative, then code X9

Code X9 when no lymph nodes are removed

Note 7: The number of examined para-aortic nodes is recorded in 3899: Number of Examined Para-

Aortic Nodes.

Code

Description

00 All para-aortic lymph nodes examined negative

01-

1-99 para-aortic lymph nodes positive

(Exact number of nodes positive)

X1 100 or more para-aortic nodes positive

X2 Positive para-aortic nodes identified, number unknown

X6 Positive aspiration or core biopsy of para-aortic lymph node(s)

X8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

X9 Not documented in medical record

Cannot be determined, indeterminate if positive para-aortic nodes present

No lymph node dissection performed

Para-aortic lymph nodes not assessed or unknown if assessed

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00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3899: Number of Examined Para-Aortic Nodes

Item Length: 2

NAACCR Item #: 3899

XML Parent-NAACCR ID: Tumor-numberOfExaminedParaAorticNodes

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00528: Cervical Sarcoma (2021+)

00530: Corpus Carcinoma and Carcinosarcoma (2018+)

00541: Corpus Sarcoma (2018+)

00542: Corpus Adenosarcoma (2018+)

Description

Number of Examined Para-Aortic nodes is the number of nodes examined based on para-aortic nodal

dissection.

Rationale

Number of Examined Para-Aortic Nodes is listed as a Registry Data Collection Variable in AJCC. This data

item was previously collected as Corpus, CS SSF #6.

Coding guidelines

Code 00 for when no nodes are examined

Code the exact number of examined nodes 01-99

Code X1 for 100 or more examined nodes

Code X2 for examined nodes, but unknown how many

Code X6 for aspiration or core biopsy of para-aortic node(s) only

Code X9 when

o Not documented in the medical record

o Para-Aortic lymph nodes not evaluated (assessed)

o No lymph node dissection performed

o Unknown if Para-Aortic lymph nodes not evaluated (assessed)

See 3899-3902: Number of Positive and Examined Para-Aortic and Pelvic Nodes for additional

information

Coding Instructions and Codes

Note 1: Physician statement of examined para-aortic nodes can be used to code this data item when no

other information is available.

Note 2: The following are para-aortic nodes

Aortic

Lateral aortic/lateral lumbar

Para-aortic, NOS

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Periaortic

Note 3: Record the number of examined para-aortic lymph nodes documented in the medical record.

Note 4: For the following

Code 00 when no lymph nodes are examined by FNA, core biopsy or removal of lymph node(s)

(e.g., sentinel lymph node biopsy or lymph node dissection)

o If a lymph node dissection is done and only pelvic lymph nodes are assessed, or only

“nodes” are documented without specifying pelvic or para-aortic, code to 00

Code X6 If only a FNA or core biopsy is done

Code X9 if it’s unknown if lymph nodes were removed

Note 5 : The number of positive para-aortic nodes is recorded in 3901: Number of Positive Para-Aortic

Nodes.

Code Description

00 No para-aortic nodes examined

01-99 1 - 99 para-aortic nodes examined

(Exact number of para-aortic lymph nodes examined)

X1 100 or more para-aortic nodes examined

X2 Para-aortic nodes examined, number unknown

No para

aortic lymph nodes removed, but aspiration or core biopsy of

para

aortic node(s)

only

X8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

X9 Not documented in medical record

Cannot be determined, indeterminate if examined para-aortic nodes present

No lymph node dissection performed

Para-aortic lymph nodes not assessed or unknown if assessed

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00530: Corpus Carcinoma and Carcinosarcoma

3902: Number of Positive Pelvic Nodes

Item Length: 2

NAACCR Item #: 3902

XML Parent-NAACCR ID: Tumor-numberOfPositivePelvicNodes

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00528: Cervical Sarcoma (2021+)

00530: Corpus Carcinoma and Carcinosarcoma

00541: Corpus Sarcoma

00542: Corpus Adenosarcoma

Description

Number of Positive Pelvic Nodes is the number of positive nodes based on pelvic nodal dissection.

Rationale

Number of Positive Pelvic Nodes is listed as a Registry Data Collection Variable in AJCC. This data item

was previously collected as Corpus, CS SSF #3.

See 3899-3902: Number of Positive and Examined Para-Aortic and Pelvic Nodes for additional

information

Coding guidelines

Code 00 for when there are no positive nodes

Code the exact number of positive nodes 01-99

Code X1 for 100 or more positive nodes

Code X2 for positive nodes, but unknown how many

Code X6 for aspiration or core biopsy of pelvic node(s) only

Code X9 when

o Not documented in the medical record

o Pelvic lymph nodes not evaluated (assessed)

o No lymph node dissection performed

o Unknown if Pelvic lymph nodes evaluated (assessed)

Additional Information

Source documents: pathology report, imaging reports, physical exam, other statements in

medical record

Coding Instructions and Codes

Note 1: Physician statement of positive pelvic nodes can be used to code this data item when no other

information is available.

Note 2: The following are pelvic nodes

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Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

Paracervical

Parametrial

Pelvis, NOS

Sacral

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Presacral

o Uterosacral

Note 3: Record the number of positive pelvic lymph nodes documented in the medical record.

Note 4: For this data item, do not include isolated tumor cells (ITCs).

Note 5: Micrometastasis and macrometastasis may be listed separately on the pathology report. Add

these two together to get the total number of positive nodes.

Note 6: Code X9 if no lymph node dissection is performed.

If only a FNA or core biopsy is done and it is positive, then code X6

If only a FNA or core biopsy is done and it is negative, then code X9

Code X9 when no lymph nodes are removed

Note 7: The number of examined pelvic nodes is recorded in 3900: Number of Examined Pelvic Nodes.

Code

Description

All pelvic nodes examined negative

01-99 1 - 99 pelvic nodes positive

(Exact number of nodes positive)

X1 100 or more pelvic nodes positive

X2 Positive pelvic nodes identified, number unknown

X6 Positive aspiration or core biopsy of pelvic lymph node(s)

X8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

X9 Not documented in medical record

Cannot be determined, indeterminate if positive pelvic nodes present

No lymph node dissection performed

Pelvic lymph nodes not assessed or unknown if assessed

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00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3900: Number of Examined Pelvic Nodes

Item Length: 2

NAACCR Item #: 3900

XML Parent-NAACCR ID: Tumor-numberOfExaminedPelvicNodes

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00528: Cervical Sarcoma (2021+)

00530: Corpus Carcinoma and Carcinosarcoma (2018+)

00541: Corpus Sarcoma (2018+)

00542: Corpus Adenosarcoma (2018+)

Description

Number of Examined Pelvic Nodes is the number of nodes examined based on pelvic nodal dissection.

Rationale

Number of Examined Pelvic Nodes is listed as a Registry Data Collection Variable in AJCC. This data item

was previously collected as Corpus, CS SSF #4.

Coding guidelines

Code 00 for when no nodes are examined

Code the exact number of examined nodes 01-99

Code X1 for 100 or more examined nodes

Code X2 for nodes examined, but unknown how many

Code X6 for aspiration or core biopsy of pelvic(s) nodes only

Code X9 when

o Not documented in the medical record

o Pelvic lymph nodes not evaluated (assessed)

o No lymph node dissection performed

o Unknown if Pelvic lymph nodes not evaluated (assessed)

See 3899-3902: Number of Positive and Examined Para-Aortic and Pelvic Nodes for additional

information

Coding Instructions and Codes

Note 1: Physician statement of examined pelvic nodes can be used to code this data item when no other

information is available.

Note 2: The following are pelvic nodes

Iliac, NOS

o Common

o External

o Internal (hypogastric) (obturator)

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Paracervical

Parametrial

Pelvis, NOS

Sacral

o Lateral (laterosacral)

o Middle (promontorial) (Gerota’s node)

o Presacral

o Uterosacral

Note 3: Record the number of examined pelvic lymph nodes documented in the medical record.

Note 4: For the following

Code 00 when no lymph nodes are examined by FNA, core biopsy or removal of lymph node(s)

(e.g., sentinel lymph node biopsy or lymph node dissection)

o If a lymph node dissection is done and only “nodes” are documented without specifying

pelvic or para-aortic, assume they are pelvic

Code X6 If only a FNA or core biopsy is done

Code X9 if it’s unknown if lymph nodes were removed

Note 5: The number of positive pelvic nodes is recorded in 3902: Number of Positive Pelvic Nodes.

Code Description

00 No pelvic lymph nodes examined

01-

1 - 99 pelvic lymph nodes examined

(Exact number of pelvic lymph nodes examined)

X1 100 or more pelvic nodes examined

X2 Pelvic nodes examined, number unknown

X6 No pelvic lymph nodes removed, but aspiration or core biopsy of pelvic node(s) only

X8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

X9 Not documented in medical record

Cannot be determined, indeterminate if examined pelvic nodes present

No lymph node dissection performed

Pelvic lymph nodes not assessed or unknown if assessed

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00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3911: Peritoneal Cytology

Item Length: 1

NAACCR Item #: 3911

XML Parent-NAACCR ID: Tumor-peritonealCytology

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00528: Cervical Sarcoma (2021+)

00530: Corpus Carcinoma and Carcinosarcoma (2018+)

00541: Corpus Sarcoma (2018+)

00542: Corpus Adenosarcoma (2018+)

Description

Peritoneal cytology pertains to the results of cytologic examination for malignant cells performed on

fluid that is obtained from the peritoneal cavity.

Rationale

Peritoneal Cytology is listed as a Registry Data Collection Variable in AJCC. This data item was previously

collected as Corpus, CS SSF #2.

Definition

Peritoneal cytology looks for malignant cells in the fluid in the pelvic and peritoneal cavities. Excess

natural fluid accumulation is called ascites. If, at laparotomy an analyzable amount of ascites is not

present, the surgeon may flood the pelvis and abdomen with saline solution then suction it out and send

the fluid for cytologic examination.

Additional Information

Source documents: cytology reports (look for multiple reports), pathology report

Other names: peritoneal washings, peritoneal lavage, possibly paracentesis (if no surgery)

Coding guidelines

Code 0 when the peritoneal cytology is reported as negative or normal

Code 1 when the peritoneal cytology test was done, and the results were reported as suspicious,

undetermined if negative or positive

Code 2 when the peritoneal cytology is reported as positive

Code 7 when test was ordered but the results are not in the medical record

Code 9 when

o No cytological specimen is available

o Peritoneal cytology not evaluated (assessed)

o Unknown if Peritoneal Cytology evaluated (assessed)

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Coding Instructions and Codes

Note 1: Physician statement of Peritoneal Cytology can be used to code this data item when no other

information is available.

Note 2: Peritoneal cytology may also be called peritoneal ascitic fluid instead of peritoneal washing or

pelvic washing.

Note 3: Cytologic examination for malignant cells may be performed on ascites (fluid that has

accumulated in the peritoneal cavity in excess amount) or the fluid (saline) that is introduced into the

peritoneal cavity or pelvis, and then removed by suction. The introduction of fluid may be termed

peritoneal or pelvic washing or peritoneal lavage.

Code Description

0 Peritoneal cytology/washing negative for malignancy

1 Peritoneal cytology/washing atypical and/or suspicious

2 Peritoneal cytology/washing malignant (positive for malignancy)

3 Unsatisfactory/nondiagnostic

7 Test ordered, results not in chart

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

Not documented in medical record

Peritoneal cytology not assessed or unknown if assessed

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00541: Corpus Sarcoma (2018+)

See 00541: Corpus Sarcoma (2018+)

3836: FIGO Stage (Sarcoma)

See 00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3901: Number of Positive Para-Aortic Nodes

3899: Number of Examined Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3900: Number of Examined Pelvic Nodes

3911: Peritoneal Cytology

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00541: Corpus Sarcoma (2018+)

3836: FIGO Stage (Sarcoma)

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2021+

Schema(s):

00528: Cervical Sarcoma (2021+)

00541: Corpus Sarcoma (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage

Code Description

1 FIGO Stage I

1A FIGO Stage IA

1B FIGO Stage IB

2 FIGO Stage II

2A FIGO Stage IIA

2B FIGO Stage IIB

3 FIGO Stage III

3A FIGO Stage IIIA

3B FIGO Stage IIIB

3C FIGO Stage IIIC

FIGO Stage IV

4A FIGO Stage IVA

4B FIGO Stage IVB

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

FIGO stage not assessed or unknown if assessed

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00542: Corpus Adenosarcoma (2018+)

See 00541: Corpus Sarcoma (2018+)

3836: FIGO Stage (Sarcoma)

See 00530: Corpus Carcinoma and Carcinosarcoma (2018+)

3901: Number of Positive Para-Aortic Nodes

3899: Number of Examined Para-Aortic Nodes

3902: Number of Positive Pelvic Nodes

3900: Number of Examined Pelvic Nodes

3911: Peritoneal Cytology

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00542: Corpus Adenosarcoma (2018+)

3836: FIGO Stage (Adenosarcoma)

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00542: Corpus Adenosarcoma (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Code Description

1 FIGO Stage I

1A FIGO Stage IA

1B FIGO Stage IB

1C FIGO Stage IC

2 FIGO Stage II

2A FIGO Stage IIA

FIGO Stage IIB

FIGO Stage III

3A FIGO Stage IIIA

3B FIGO Stage IIIB

3C FIGO Stage IIIC

4 FIGO Stage IV

4A FIGO Stage IVA

4B FIGO Stage IVB

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

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00551: Ovary (2018+)

3836: FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00551: Ovary (2018+)

00552: Primary Peritoneal Carcinoma (2018+)

00553: Fallopian Tube (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Note 4: For High-grade (HGSC) serous tubal intraepithelial carcinoma (STIC) (8441/2), assign the FIGO

stage based on the managing physician's documentation of FIGO. (See Note 1).

If FIGO stage for HGSC or STIC is not documented by the managing physician, code unknown

(code 99)

Do not code 97 (in situ) for HGSC or STIC since FIGO does not have a Stage 0

If diagnosis is low grade serous intraepithelial carcinoma (LGSC) (8441/2) or serous

intraepithelial carcinoma (no grade stated) (8441/2), code 97

Note 5: Code 97 for any remaining in situ histologies (/2) since the FIGO stage definitions do not include

Stage 0.

Code Description

1 FIGO Stage I

1A FIGO Stage IA

1B FIGO Stage IB

1C FIGO Stage IC

1C1 FIGO Stage IC1

1C2 FIGO Stage IC2

1C3 FIGO Stage IC3

2 FIGO Stage II

2A FIGO Stage IIA

2B FIGO Stage IIB

3 FIGO Stage III

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Code Description

3A FIGO Stage IIIA

3A1 FIGO Stage IIIA1

3A11 FIGO Stage IIIA1i

3A12 FIGO Stage IIIA1ii

3A2 FIGO Stage IIIA2

FIGO Stage IIIB

3C FIGO Stage IIIC

4 FIGO Stage IV

4A FIGO Stage IVA

4B FIGO Stage IVB

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

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00551: Ovary (2018+)

3818: CA-125 Pretreatment Interpretation

Item Length: 1

NAACCR Item #: 3818

XML Parent-NAACCR ID: Tumor-ca125PretreatmentInterpretation

NAACCR Alternate Name: CA-125 (Carbohydrate Antigen 125) Pretreatment Interpretation

Active years: 2018+

Schema(s):

00551: Ovary (2018+)

00552: Primary Peritoneal Carcinoma (2018+)

00553: Fallopian Tube (2018+)

Description

Carbohydrate Antigen 125 (CA-125)/CA-125 II is a tumor marker that is useful for following the response

to therapy in patients with ovarian cancer, who may have elevated levels of this marker.

Rationale

Preoperative CA-125/CA-125 II is a Registry Data Collection Variable listed in AJCC. It was previously

collected as Ovary, CS SSF #1.

Definition

CA-125/CA-125 II is a tumor marker that is not specific to ovarian or primary peritoneal cancer but is

useful to monitor for success of treatment and recurrence. Because it can be elevated in many diseases

affecting the peritoneal lining of the abdominal and pelvic cavity, it is not a screening test for women

who have no history of cancer. Any value over 35 is highly correlated with cancer and about 80% of

ovarian cancers show an elevated CA-125/CA-125 II. However, a result in the normal range does not

rule out cancer. Values up to 65 U/ml may be considered borderline, and values over 200 are unlikely to

be due to a benign condition. CA-125/CA-125 II monitors for success of treatment and

recurrence. After obtaining a baseline value prior to treatment, a lower result on a subsequent test

indicates a response to treatment, and an increasing value indicates possible recurrence.

Coding guidelines

Record the clinician’s interpretation of the highest value prior to treatment from a blood or serum test,

based on the reference range used by the lab. Do not code the result from thoracentesis or

paracentesis fluid.

Code 0 when the CA-125/CA-125 II is reported as negative or normal.

Code 1 when the CA-125/CA-125 II is reported as positive or elevated.

Code 2 when the CA-125/CA-125 II is reported as borderline; undetermined whether positive or

negative.

Code 7 when the CA-125/CA-125 II test was ordered but the results are not in the medical

record.

Code 9 when

o No information in the medical record

o CA-125/CA-125 II test not done (not assessed)

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o Unknown if CA-125/CA-125 II test was performed (unknown if assessed)

Additional Information

Source documents: clinical laboratory report (blood or serum test); may be reported in history,

clinician or consultant notes or pathology report

Other names: Cancer Antigen 125, CA 125, CA125, Carbohydrate Antigen 125, mucin 16,

MUC16, CA 125 II

Normal reference range

o < 35 units per milliliter (U/ml); SI: < 35 kiloUnits/Liter (KU/L).

o May also be reported as micrograms/milliliter ( g/mL or ug/mL).

o Normal reference range may vary depending on the laboratory running the test.

Coding Instructions and Codes

Note 1: Physician statement of CA-125/CA-125 II pretreatment interpretation can be used to code this

data item when no other information is available.

Note 2: Carbohydrate Antigen 125 (CA-125/CA-125 II), also known as cancer antigen 125, mucin 16, or

MUC16, is a protein which in humans is encoded by the MUC16 gene. CA-125 is a tumor marker or

biomarker that may be elevated in the blood of some patients with ovarian cancer.

Note 3: Record only the blood or serum CA-125/CA-125 II interpretation for this data item. Do not

record CA-125 test results based on fluid from the chest or abdominal cavity.

Note 4: Record the CA-125/CA-125 II status prior to treatment.

Note 5: Normal values may vary with patient age and from lab to lab. The typical human reference

ranges are 0 to less than or equal 35 units per milliliter (U/mL). This is equivalent to kU/L.

Note 6: Code 9 if there is no statement that the CA-125/CA-125 II is positive/elevated, negative/normal,

and the lab value with its normal range (from which you can determine interpretation) is not

documented.

Code Description

Negative/normal; within normal limits

Positive/elevated

2 Stated as borderline; undetermined whether positive or negative

7 Test ordered, results not in chart

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error)

Not documented in m

edical record

CA-125 not assessed or unknown if assessed

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00551: Ovary (2018+)

3921: Residual Tumor Volume Post Cytoreduction

Item Length: 2

NAACCR Item #: 3921

XML Parent-NAACCR ID: Tumor-residualTumVolPostCytoreduction

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00551: Ovary (2018+)

00552: Primary Peritoneal Carcinoma (2018+)

00553: Fallopian Tube (2018+)

Description

Gross residual tumor after primary cytoreductive surgery is a prognostic factor for ovarian cancer and

residual tumor volume after cytoreductive surgery is a prognostic factor for late stage ovarian cancers.

Rationale

Residual Tumor Volume Post Cytoreduction is a Registry Data Collection Variable listed in AJCC. It was

previously collected as Ovary, CS SSF # 3.

Definition

The amount of ovarian tumor and the location of tumor remaining in the patient after initial ovarian or

peritoneal cancer surgery are the most important prognostic factors for advanced disease. The intent of

cytoreductive or debulking surgery—particularly for Stage III cancer—is to remove as much of the

cancer in the pelvis and abdomen as possible so that chemotherapy will be more effective. The less

tumor left behind, the more likely the patient will respond well to adjuvant hemotherapy. Information

about residual tumor volume will be in the operative report.

Additional Information

Source documents: operative report, discharge summary, chemotherapy records (inpatient and

outpatient)

For further information, refer to the Ovary, Fallopian Tube, or Peritoneum cancer protocol

published by the College of American Pathologists for the AJCC Staging System Ovary, Fallopian

Tube, and Primary Peritoneal Carcinoma

Other names: debulking, cytoreduction, residual tumor volume

Change for SSDI (effective v2.0): Further review of this SSDI indicated that the distinction of

whether patient had neoadjuvant therapy or not was not needed. The purpose of this data item

is to determine the residual tumor left behind. The codes have been redone so that they only

collect that information.

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Coding Instructions and Codes

Note 1: Physician statement of residual tumor status after primary cytoreduction surgery can be used to

code this data item when no other information is available.

Note 2: Information for this SSDI is found in the operative report, procedure report, or managing

physician notes.

Note 3: The surgery to remove as much cancer in the pelvis and/or abdomen as possible, reducing the

"bulk" of the cancer, is called "debulking" or "cytoreductive" surgery. It is performed when there is

widespread evidence of advanced stage of ovarian cancer with obvious spread to other organs outside

the ovary, typically in the upper abdomen, intestines, the omentum (the fat pad suspended from the

transverse colon like an apron), the diaphragm, or liver.

Note 4: Optimal debulking is described as removal of all tumor except for residual nodules that measure

no more than 1 centimeter (cm) in maximum diameter.

Note 5: Gross residual tumor after primary cytoreductive surgery is a prognostic factor that has been

demonstrated in large studies. The best prognostic category after surgery includes those who are left

with no gross residual tumor.

Physicians should record the presence or absence of residual disease, if residual disease is

observed, the size of the largest visible lesion should be documented

Code Description

00 No gross residual tumor nodules

50 Residual tumor nodule(s) 1 centimeter (cm) or less

60 Residual tumor nodule(s) greater than 1 cm

70 Macroscopic residual tumor, size not stated

80 Procedure described as optimal debulking and size of residual tumor nodule(s) not given

97 No cytoreductive surgery performed

Non-invasive neoplasm (behavior /2)

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

Residual tumor status after cytoreductive surgery not assessed or unknown if assessed

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00552: Primary Peritoneal Carcinoma (2018+)

See 00551: Ovary

3836: FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma

3818: CA-125 Pretreatment Interpretation

3921: Residual Tumor Volume Post Cytoreduction

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00553: Fallopian Tube (2018+)

See 00551: Ovary

3836: FIGO: Ovary, Fallopian Tube, and Peritoneal Carcinoma

3818: CA-125 Pretreatment Interpretation

3921: Residual Tumor Volume Post Cytoreduction

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00560: Placenta (2018+)

3836: FIGO: Gestational Trophoblastic Tumors (Placenta)

Item Length: 5

NAACCR Item #: 3836

XML Parent-NAACCR ID: Tumor-figoStage

NAACCR Alternate Name: FIGO Stage

Active years: 2018+

Schema(s):

00560: Placenta (2018+)

Note 1: There must be a statement about FIGO stage from the managing physician in order to code this

data item.

Do not code FIGO stage based on the pathology report

Do not code FIGO stage based only on T, N, M

If "FIGO" is not included with a stated stage, then do not assume it is a FIGO stage

Note 2: FIGO stage is not the same thing as FIGO grade. Only code FIGO stage in this field, do not code

FIGO grade.

Code FIGO grade in the grade fields

Note 3: If there is more than one FIGO stage provided from the clinical and pathological work up, code

the most extensive FIGO stage.

Note 4: The FIGO stage definitions do not include Stage 0 (Tis).

Code 97 for any non-invasive neoplasm (behavior /2)

Code

Description

1 FIGO Stage I

2 FIGO Stage II

3 FIGO Stage III

4 FIGO Stage IV

97 Not applicable: Carcinoma in situ (intraepithelial, noninvasive, preinvasive)

98 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 98 will result in an edit error.)

99 Not documented in medical record

FIGO stage unknown, not assessed or unknown if assessed

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00560: Placenta (2018+)

3837: Gestational Trophoblastic Prognostic Scoring Index

Item Length: 2

NAACCR Item #: 3837

XML Parent-NAACCR ID: Tumor-gestationalTrophoblasticPxIndex

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00560: Placenta (2018+)

Description

Gestational Trophoblastic Prognostic Scoring Index, a score based on the FIGO-modified World Health

Organization (WHO) Prognostic Scoring Index, is used to stratify women with gestational trophoblastic

neoplasia in addition to the anatomical stage group. The risk score is appended to the anatomic stage.

Rationale

This data item is required for prognostic stage grouping in AJCC 8

edition, Chapter 56 Gestational

Trophoblastic Neoplasms. It was previously collected as Placenta, CS SSF # 1.

Definition

The Prognostic Index is a non-anatomic risk factor scoring system that adds a fourth dimension to the

stage grouping of gestational trophoblastic tumors (GTT) of the placenta. The score subcategorizes GTTs

into low risk or high risk based on a point system. Code the clinician’s statement of the total point value

for the Prognostic Index in priority over the clinician’s statement of risk. Registrars are NOT to calculate

the score.

Coding Instructions and Codes

Note 1: This is based on clinician scoring only. The registrar is NOT to calculate the score based on

available information.

Note 2: The Prognostic Scoring Index is based on the following components

Age

Antecedent Pregnancy

Interval in Months from Index Pregnancy

Pretreatment Serum human chorionic gonadotropin (hCG) (mIU/ml)

Largest Tumor Size, Including Uterus

Sites of Metastases

Number of Metastases Identified

Previous Failed Chemotherapy

Note 3: The total score ranges from 00-25.

Note 4: If there is no clinician scoring, or a stated value is greater than 25, code X9.

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Code Description

00-25 Risk factor score

Not

documented in medical record

Prognostic scoring index not assessed, or unknown if assessed

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MALE GENITAL ORGANS

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00570: Penis (2018+)

See 00460: Merkel Cell Carcinoma (2018+)

3830: Extranodal Extension Clin (non-Head and Neck)

3833: Extranodal Extension Path (non-Head and Neck)

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00580: Prostate (2018+)

3920: PSA (Prostatic Specific Antigen) Lab Value

Item Length: 5

NAACCR Item #: 3920

XML Parent-NAACCR ID: Tumor-psaLabValue

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

PSA (Prostatic Specific Antigen) is a protein produced by cells of the prostate gland and is elevated in

patients with prostate cancer. This data item pertains to PSA lab value.

Rationale

This data item is required for prognostic stage grouping in AJCC 8

edition, Chapter 58 Prostate. It was

previously collected as Prostate, CS SSF #1.

Definition

Serum PSA is the most sensitive tumor marker for monitoring individuals with prostate cancer, including

progression of disease and response to therapy. Although originally not intended to be a screening test,

this relatively simple blood test has become a very common method of detecting new prostate cancer in

its earliest stages. PSA can be totally negative when prostate cancer is found on digital rectal exam. In

such cases, PSA will not be helpful in monitoring for recurrence.

Note: Serum PSA is not the same as free PSA or precursor PSA—do not record values from

either of these tests in this field.

Additional Information

Source documents: clinical laboratory report (blood or serum test), history, clinician note,

pathology report

Other names: Prostate specific antigen, serum PSA, total PSA

Normal reference range: varies by age and race of patient.

The reference range should be shown on the clinical laboratory report. In general, normal

findings are 0 – 4.0 nanograms per milliliter (ng/ml).

Optimal normal range is 0 – 2.6 ng/ml. Nanograms per milliliter may be reported as micrograms

per liter ( g/L or ug/L).

Coding Guidelines

Record the last pre-diagnosis PSA lab value prior to diagnostic biopsy of prostate and initiation of

treatment in nanograms per milliliter (ng/ml) in the range 0.1 (.1 ng/ml) to 999.9 (999.9 ng/ml).

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Note: This is a change from CSv2, where the instructions stated to code the highest PSA value

within 3 months prior to diagnostic biopsy

Examples Code Explanation

PSA 11.56 11.6 PSA documented in tenths, round up

1/5/2018: PSA 5.8

1/29/2018: PSA 5.2

2/22/2018: Biopsy positive for adenocarcinoma

5.2 PSA lab value closest and prior to the

diagnostic biopsy

12/19/2017: PSA 44.3

3/11/2018: PSA 42.8

5/1/2018: DRE positive for bilateral palpable

nodularity

5/5/2018: Casodex initiated without needle core

biopsy

42.8 PSA lab value closest to the initiation of

treatment

2/16/2018: PSA 18.6, adjusted PSA value due to

patient taking Medication for benign prostatic

hypertrophy

18.6 Record the adjusted PSA value ONLY if

documented by the clinician in the

record.

Registrar does not adjust the PSA value

due to BPH medication use

1,100 ng/ml XXX.1 XXX.1 is defined for values of 1,000 or

greater

No PSA done or unknown if done XXX.9 Definition of unknown

Coding Instructions and Codes

Note 1: Physician statement of prostatic specific antigen (PSA) pre-diagnosis can be used to code this

data item when no other information is available.

Note 2: PSA is a prognostic factor required for AJCC staging. It affects the stage group in most cases.

Note 3: Record to the nearest tenth in nanograms/milliliter (ng/ml) the last pre-diagnosis PSA lab value

prior to diagnostic biopsy of prostate and treatment. The lab value may be recorded in the lab report,

history and physical, or clinical statement in the pathology report, etc.

A lab value expressed in micrograms per liter (ug/L) is equivalent to the same value expressed in

nanograms per milliliter (ng/ml)

Record 0.1 when the lab results are stated as less than 0.1 ng/ml with no exact value.

Examples:

o PSA of 7.2. Code 7.2

o PSA of 10. Code 10.0

o PSA of 8.56. Code 8.6

o PSA of 110.35. Code 110.4

Note 4: A known lab value takes priority over codes XXX.2 and XXX.3

The lab value takes priority even if the physician documents the interpretation

Example: Patient noted to have a PSA of 7.6. Physician notes that the value is elevated

o Code 7.6 instead of XXX.3 (elevated)

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Note 5: A discrepancy between the PSA documented in the lab report and the PSA documented by the

clinician may arise due to the clinician’s adjusting the PSA value. Certain medications for benign

prostatic hypertrophy (BPH) decrease the PSA.

If there is documentation by a clinician within the medical record of an adjusted PSA value,

record the adjusted value.

The registrar does not adjust the PSA value based on BPH medication use.

If there is no documentation by a clinician within the medical record of an adjusted PSA value,

record the PSA value provided.

The fact that an adjusted PSA value is being recorded should be documented in the Dx Proc –

Lab Tests text field (NAACCR Item #2550).

Code Description

0.1 0.1 or less nanograms/milliliter (ng/ml)

(Exact value to nearest tenth of ng/ml)

0.2-999.9 0.2 – 999.9 ng/ml

(Exact value to nearest tenth of ng/ml)

XXX.1 1,000 ng/ml or greater

XXX.2 Lab value not available, physician states PSA is negative/normal

XXX.3

Lab value not available, physician states PSA is

positive/elevated/high

XXX.7 Test ordered, results not in chart

XXX.9 Not documented in medical record

PSA lab value not assessed or unknown if assessed

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Prostate

Gleason Patterns and Scores

Definition

The Gleason system for grading prostate cancer is the one recommended by the AJCC and College of

American Pathologists. The following data items are used to collect information on Gleason.

3838: Gleason Patterns Clinical

3839: Gleason Patterns Pathological

3840: Gleason Score Clinical

3841: Gleason Score Pathological

3842: Gleason Tertiary Pattern

Gleason Patterns

The pathologist determines the Gleason patterns by looking at the prostate tissue under the

microscope. The pathologist assigns a grade to the most predominant pattern (largest surface area of

involvement, more than 50% of tissue) and a grade for the secondary pattern (second most

predominant) based on published Gleason criteria. When a patient undergoes radical prostatectomy,

the pathologist may look for a third or tertiary pattern in the specimen. When Gleason pattern 5 is

present as a tertiary pattern, its presence should be indicated in the pathology report, as a high Gleason

pattern appears to be an indicator for worse outcome (shortened time to recurrence). Studies indicate

that a Gleason score 7, with tertiary pattern 5, is associated with a worse prognosis than without tertiary

pattern 5 and is similar to the prognosis for Gleason score 8 – 10.

For example, in a specimen where the primary Gleason pattern is 3, the secondary is 4 and there

is less than 5% Gleason 5, the report should indicate a Gleason score of 7 (3+4) with tertiary

Gleason pattern 5. Gleason grades (patterns) range from 1 (small, uniform gland) to 5 (lack of

glands, sheets of cells.)

For the Gleason Patterns data items, there is a long list of codes and definitions in the table, but it may

be easier to assign a value if you understand the structure of the code. This is a two-digit field.

First digit is the Gleason primary pattern value

Second digit is the Gleason secondary pattern value

Gleason Score

The Gleason score is the sum of the values of the Gleason primary and secondary patterns. A low

Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to

spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is

more likely to spread.

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Coding guidelines

Clinical Gleason Patterns and Score

Clinical Gleason Pattern and Score: Used to code information on the Gleason pattern from a needle core

biopsy or transurethral resection of the prostate (TURP) only. Gleason patterns from prostate tissue on a

transurethral resection of the bladder (TURB) specimen can also be used.

If there are multiple needle core biopsies or if both needle core biopsy and TURP are performed, code

the patterns and score from the specimen with the highest score.

Examples for Clinical Gleason Patterns and Score

Examples Pattern Code Score Code

Gleason 3+3 33 06

Gleason 4+3 43 07

Gleason 4 (Assume a number in the range 2-5 is a primary

pattern and code unknown (9) in the second digit)

49 X9

Gleason 7 (Assume a number in the range 6-10 is a score) X6 07

Gleason 10 (only combination of values that equals 10 is 5+5) 55 10

Needle core biopsy or TURP not done X7 X7

Gleason not done, or unknown if done X9 X9

Pathological Gleason Patterns and Score

Used to code information on the Gleason patterns from a prostatectomy or autopsy.

Examples for Pathological Gleason Patterns and Score

Examples Pattern Code Score Code

Gleason 3+3

Gleason 4+3

Gleason 4 (Assume a number in the range 2-5 is a primary

pattern and code unknown (9) in the second digit)

49 X9

Gleason 7 (Assume a number in the range 6-10 is a score) X6 07

Gleason 10 (only combination of values that equals 10 is 5+5) 55 10

No prostatectomy done X7 X7

Gleason not done, or unknown if done X9 X9

Tertiary Gleason Pattern

Used to code information on the Gleason tertiary pattern from a prostatectomy.

Examples for Tertiary Gleason Pattern

Examples Code

Tertiary pattern 3 30

Tertiary pattern 4 40

No prostatectomy done X7

Tertiary pattern not done, or unknown if done X9

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Additional Information

Clinical: pathology reports from needle biopsies or transurethral resection of prostate/bladder

that contains prostate tissue

o Pathological: pathology report from prostatectomy or autopsy report

For further information, refer to the Prostate cancer protocol published by the College of

American Pathologists for the AJCC Staging System Prostate

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00580: Prostate (2018+)

3838: Gleason Patterns Clinical

Item Length: 2

NAACCR Item #: 3838

XML Parent-NAACCR ID: Tumor-gleasonPatternsClinical

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

Prostate cancers are graded using Gleason score or pattern. This data item represents the Gleason

primary and secondary patterns from needle core biopsy or TURP.

Rationale

Gleason Patterns Clinical is a Registry Data Collection Variable for Clinical Stage for AJCC. This data item

was previously collected as Prostate, CS SSF #7.

See Gleason Patterns and Scores for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Gleason Patterns Clinical can be used to code this data item when there

is no other information available.

Note 2: Code the Gleason primary and secondary patterns from a needle core biopsy, trans rectal

ultrasound (TRUS) guided biopsy, or transurethral resection of prostate (TURP) and/or simple

prostatectomy in this field.

Gleason primary and secondary patterns provided for any prostate tissue identified from a

transurethral resection of a bladder tumor (TURBT) specimen can also be used in this field.

Note 3: Code the Gleason primary and secondary patterns prior to neoadjuvant treatment.

Note 4: Usually prostate cancers are graded using Gleason score or pattern. Gleason grading for

prostate primaries is based on a 5-component system (5 histologic patterns). Prostatic cancer generally

shows two main histologic patterns. The primary pattern, the pattern occupying greater than 50% of the

cancer, is usually indicated by the first number of the Gleason grade, and the secondary pattern is

usually indicated by the second number. These two numbers are added together to create a pattern

score.

If there are two numbers, assume that they refer to two patterns (the first number being the

primary pattern and the second number the secondary pattern), and sum them to obtain the

score.

If only one number is given, and it is less than or equal to 5, assume that it describes a pattern

(since scores of 5 or less would reflect Primary or Secondary Pattern Scores of 1 or 2). Code the

number as the primary pattern and code the secondary pattern as Unknown.

o For example, if only one number is given, and it is a 3, code “39” for Gleason Patterns

and “X9” for Gleason Score.

If only one number is given, and it is greater than 5, assume that it is a score.

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o For example, if only one number is given, and it is a 7, code “X6” for Gleason Patterns

and “07” for Gleason Score.

If the pathology report specifies a specific number out of a total of 10, the first number given is

the score.

o For example, if the pathology report says Gleason 7/10, code “07’ for Gleason Score and

“X6” for Gleason Patterns.

Note 5: If the only information available is the Gleason Score, code the patterns X6 (primary pattern

unknown, secondary pattern unknown).

Note 6: If different patterns are documented on multiple needle core biopsies, code the pattern that

reflects the highest or most aggressive score regardless if the pathologist provides an overall pattern in a

final summary. If different patterns equal the same high score, give priority to the highest primary

pattern and then the highest secondary pattern.

For example, both Gleason 3, 4 and Gleason 4, 3 equal Gleason score 7; code 43. Do not mix

patterns from multiple specimens.

Note 7: If multiple procedures are performed (e.g., needle core biopsy, trans rectal ultrasound (TRUS)

guided biopsy, transurethral resection of prostate (TURP), and/or simple prostatectomy), code the

pattern that reflects the highest score.

Note 8: Do not infer Gleason Primary and Secondary Pattern from Grade Group (Code X9).

Note 9: The clinical score is recorded in 3840: Gleason Score Clinical.

Code Description

11 Primary pattern 1, secondary pattern 1

12 Primary pattern 1, secondary pattern 2

13 Primary pattern 1, secondary pattern 3

14 Primary pattern 1, secondary pattern 4

15 Primary pattern 1, secondary pattern 5

19 Primary pattern 1, secondary pattern unknown

21 Primary pattern 2, secondary pattern 1

22 Primary pattern 2, secondary pattern 2

Primary pattern 2, secondary pattern 3

24 Primary pattern 2, secondary pattern 4

25 Primary pattern 2, secondary pattern 5

29 Primary pattern 2, secondary pattern unknown

31 Primary pattern 3, secondary pattern 1

32 Primary pattern 3, secondary pattern 2

33 Primary pattern 3, secondary pattern 3

34 Primary pattern 3, secondary pattern 4

35 Primary pattern 3, secondary pattern 5

39 Primary pattern 3, secondary pattern unknown

41 Primary pattern 4, secondary pattern 1

42 Primary pattern 4, secondary pattern 2

43 Primary pattern 4, secondary pattern 3

44 Primary pattern 4, secondary pattern 4

45 Primary pattern 4, secondary pattern 5

Primary pattern 4, secondary pattern unknown

Primary pattern 5, secondary pattern 1

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Code Description

52 Primary pattern 5, secondary pattern 2

53 Primary pattern 5, secondary pattern 3

54 Primary pattern 5, secondary pattern 4

55 Primary pattern 5, secondary pattern 5

59 Primary pattern 5, secondary pattern unknown

TURP and/or Biopsy done, p

rimary pattern unknown, secondary pattern unknown

X7 No needle core biopsy/TURP performed

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit

error.)

Not documented in medical record

Gleason Patterns Clinical not assessed or unknown if assessed

Unknown whether TURP and/or Biopsy done

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00580: Prostate (2018+)

3840: Gleason Score Clinical

Item Length: 2

NAACCR Item #: 3840

XML Parent-NAACCR ID: Tumor-gleasonScoreClinical

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

This data item records the Gleason score based on adding the values for primary and secondary patterns

in Needle Core Biopsy or TURP.

Rationale

Gleason Score Clinical is a Registry Data Collection Variable for AJCC. This data item was previously

collected as Prostate, CS SSF #8.

See Gleason Patterns and Scores for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Gleason Score Clinical can be used to code this data item when there is

no other information available.

Note 2: Code the Gleason Score Clinical from a needle core biopsy, trans rectal ultrasound (TRUS)

guided biopsy, transurethral resection of prostate (TURP), and/or simple prostatectomy in this field.

Gleason primary and secondary patterns provided for any prostate tissue identified from a

transurethral resection of a bladder tumor (TURBT) specimen can also be used in this field.

Note 3: Code the Gleason Score prior to neoadjuvant treatment.

Note 4: Usually prostate cancers are graded using Gleason's score or pattern. Gleason's grading for

prostate primaries is based on a 5-component system (5 histologic patterns). Prostatic cancer generally

shows two main histologic patterns. The primary pattern, the pattern occupying greater than 50% of the

cancer, is usually indicated by the first number of the Gleason's grade, and the secondary pattern is

usually indicated by the second number. These two numbers are added together to create a pattern

score, ranging from 2 to 10.

If there are two numbers, assume that they refer to two patterns (the first number being the

primary pattern and the second number the secondary pattern), and sum them to obtain the

score.

If only one number is given, and it is less than or equal to 5, code the total score to X9, unknown

or no information.

If only one number is given, and it is greater than 5, assume that it is a score and code as stated.

If the pathology report specifies a specific number out of a total of 10, the first number given is

the score.

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o Example: The pathology report says Gleason's 3/10. The Gleason's score would be 3 and

coded as 03.

Note 5: If different scores are documented on multiple needle core biopsies, code the highest or most

aggressive score.

Note 6: If multiple procedures are performed (e.g., needle core biopsy, trans rectal ultrasound (TRUS)

guided biopsy, transurethral resection of prostate (TURP), and/or simple prostatectomy), code the

highest score.

Note 7: Do not infer the Gleason Score from Grade Group (Code X9).

Note 8: Record the Gleason score based on the addition of the primary and secondary patterns coded in

3838: Gleason Patterns Clinical.

Code Description

02 Gleason score 2

03 Gleason score 3

04 Gleason score 4

05 Gleason score 5

06 Gleason score 6

Gleason score 7

Gleason score 8

09 Gleason score 9

10 Gleason score 10

X7 No needle core biopsy/TURP performed

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit

error.)

X9 Not documented in medical record

Gleason Score Clinical not assessed or unknown if assessed

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00580: Prostate (2018+)

3839: Gleason Patterns Pathological

Item Length: 2

NAACCR Item #: 3839

XML Parent-NAACCR ID: Tumor-gleasonPatternsPathological

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

Prostate cancers are graded using Gleason score or pattern. This data item represents the Gleason

primary and secondary patterns from prostatectomy or autopsy.

Rationale

Gleason Patterns Pathological is a Registry Data Collection Variable for AJCC. This data item was

previously collected as Prostate, CS SSF #9.

See Gleason Patterns and Scores for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Gleason Patterns Pathological can be used to code this data item when

there is no other information available.

Note 2: Code the Gleason primary and secondary patterns from a radical prostatectomy or autopsy only

in this field. Unlike Grade Group Pathological, do not include patterns from tissues taken prior to a

radical prostatectomy.

Code results from a transurethral resection of prostate (TURP) or simple prostatectomy in

Gleason Patterns Clinical

Note 3: Usually prostate cancers are graded using Gleason score or pattern. Gleason grading for

prostate primaries is based on a 5-component system (5 histologic patterns). Prostatic cancer generally

shows two main histologic patterns. The primary pattern, the pattern occupying greater than 50% of the

cancer, is usually indicated by the first number of the Gleason grade, and the secondary pattern is

usually indicated by the second number. These two numbers are added together to create a pattern

score.

If there are two numbers, assume that they refer to two patterns (the first number being the

primary pattern and the second number the secondary pattern), and sum them to obtain the

score.

If only one number is given, and it is less than or equal to 5, assume that it describes a pattern

(since scores of 5 or less would reflect Primary or Secondary Pattern Scores of 1 or 2). Code the

number as the primary pattern and code the secondary pattern as Unknown.

o For example, if only one number is given, and it is a 3, code “39” for Gleason Patterns

and “X9” for Gleason Score.

If only one number is given, and it is greater than 5, assume that it is a score.

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o For example, if only one number is given, and it is a 7, code “X6” for Gleason Patterns

and “07” for Gleason Score.

If the pathology report specifies a specific number out of a total of 10, the first number given is

the score.

o For example, if the pathology report says Gleason 7/10, code “07” for Gleason Score

and “X6” for Gleason Patterns.

Note 4: If the only information available is the Gleason Score, code the patterns X6 (primary pattern

unknown, secondary pattern unknown).

Note 5: If different patterns are documented on multiple specimens, code the pattern that reflects the

highest or most aggressive score regardless if the pathologist provides and overall pattern in a final

summary. If different patterns equal the same high score, give priority to the highest primary pattern

and then the highest secondary pattern.

Note 6: If neoadjuvant therapy was given, code Gleason pathological patterns as X9.

Note 7: Do not infer Gleason Primary and Secondary Pattern from Grade Group (Code X9).

Note 8: If a tertiary pattern is documented on prostatectomy or autopsy, code in 3842: Gleason Tertiary

Pattern.

Note 9: The pathological score is recorded in 3841: Gleason Score Pathological.

Code Description

11 Primary pattern 1, secondary pattern 1

12 Primary pattern 1, secondary pattern 2

Primary pattern 1, secondary pattern 3

Primary pattern 1, secondary pattern 4

15 Primary pattern 1, secondary pattern 5

19 Primary pattern 1, secondary pattern unknown

21 Primary pattern 2, secondary pattern 1

22 Primary pattern 2, secondary pattern 2

23 Primary pattern 2, secondary pattern 3

24 Primary pattern 2, secondary pattern 4

25 Primary pattern 2, secondary pattern 5

29 Primary pattern 2, secondary pattern unknown

31 Primary pattern 3, secondary pattern 1

32 Primary pattern 3, secondary pattern 2

33 Primary pattern 3, secondary pattern 3

34 Primary pattern 3, secondary pattern 4

35 Primary pattern 3, secondary pattern 5

39 Primary pattern 3, secondary pattern unknown

Primary pattern 4, secondary pattern 1

Primary pattern 4, secondary pattern 2

43 Primary pattern 4, secondary pattern 3

44 Primary pattern 4, secondary pattern 4

45 Primary pattern 4, secondary pattern 5

49 Primary pattern 4, secondary pattern unknown

51 Primary pattern 5, secondary pattern 1

52 Primary pattern 5, secondary pattern 2

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Code Description

53 Primary pattern 5, secondary pattern 3

54 Primary pattern 5, secondary pattern 4

55 Primary pattern 5, secondary pattern 5

59 Primary pattern 5, secondary pattern unknown

X6 Prostatectomy done, primary pattern unknown, secondary pattern unknown

radical

prostatectomy/autopsy performed

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit

error.)

X9 Not documented in medical record

Gleason Patterns Pathological not assessed or unknown if assessed

Unknown if radical prostatectomy done

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00580: Prostate (2018+)

3841: Gleason Score Pathological

Item Length: 2

NAACCR Item #: 3841

XML Parent-NAACCR ID: Tumor-gleasonScorePathological

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

This data item records the Gleason score based on adding the values for primary and secondary patterns

from prostatectomy or autopsy.

Rationale

Gleason Score Pathological is a Registry Data Collection Variable for AJCC. This data item was previously

collected as Prostate, CS SSF #10.

See Gleason Patterns and Scores for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Gleason Score Pathological can be used to code this data item when

there is no other information available.

Note 2: Code the Gleason Score Pathological from a radical prostatectomy or autopsy only in this field.

Unlike Grade Group Pathological, do not include patterns from tissues taken prior to a radical

prostatectomy.

Code results from a transurethral resection of prostate (TURP) or simple prostatectomy in

Gleason Score Clinical

Note 3: Usually prostate cancers are graded using Gleason's score or pattern. Gleason's grading for

prostate primaries is based on a 5-component system (5 histologic patterns). Prostatic cancer generally

shows two main histologic patterns. The primary pattern, the pattern occupying greater than 50% of the

cancer, is usually indicated by the first number of the Gleason's grade, and the secondary pattern is

usually indicated by the second number. These two numbers are added together to create a pattern

score, ranging from 2 to 10.

If there are two numbers, assume that they refer to two patterns (the first number being the

primary pattern and the second number the secondary pattern), and sum them to obtain the

score.

If only one number is given, and it is less than or equal to 5, code the total score to X9, unknown

or no information.

If only one number is given, and it is greater than 5, assume that it is a score and code as stated.

If the pathology report specifies a specific number out of a total of 10, the first number given is

the score.

o Example: The pathology report says Gleason's 3/10. The Gleason's score would be 3 and

coded as 03.

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Note 4: If neoadjuvant therapy was given, code Gleason pathological score as X9.

Note 5: Do not infer the Gleason Score from Grade Group (Code X9).

Note 6: Record the Gleason score based on the addition of the primary and secondary patterns coded in

3839: Gleason Patterns Pathological.

Code Description

02 Gleason score 2

03 Gleason score 3

04 Gleason score 4

05 Gleason score 5

06 Gleason score 6

07 Gleason score 7

08 Gleason score 8

09 Gleason score 9

10 Gleason score 10

X7 No radical prostatectomy done/autopsy performed

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit

error.)

X9 Not documented in medical record

Gleason Score Pathological not assessed or unknown if assessed

Unknown if radical prostatectomy done

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00580: Prostate (2018+)

3842: Gleason Tertiary Pattern

Item Length: 2

NAACCR Item #: 3842

XML Parent-NAACCR ID: Tumor-gleasonTertiaryPattern

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

Prostate cancers are graded using Gleason score or pattern. This data item represents the tertiary

pattern value from prostatectomy or autopsy.

Rationale

Tertiary Gleason pattern on prostatectomy is a Registry Data Collection Variable for AJCC. This data item

was previously collected as Prostate, CS SSF #11.

See Gleason Patterns and Scores for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Gleason tertiary pattern can be used to code this data item when there is

no other information available.

Note 2: If present, a high Gleason Tertiary Pattern appears to be an indication for a worse outcome.

Note 3: Record the tertiary pattern documented on radical prostatectomy or autopsy only. Record the

tertiary pattern prior to neoadjuvant treatment.

If a tertiary pattern is documented on needle core biopsy or transurethral resection of prostate

(TURP), it should be disregarded

Do not code the tertiary pattern on radical prostatectomy or autopsy in Gleason Patterns

Pathological

Note 4: The CAP Prostate protocol does not include Patterns 1 and 2 for Tertiary Pattern.

Note 5: If neoadjuvant therapy was given, code Gleason patterns as X9.

Code Description

Tertiary pattern 1

Tertiary pattern 2

30 Tertiary pattern 3

40 Tertiary pattern 4

50 Tertiary pattern 5

X7 No radical prostatectomy/autopsy performed

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit error.)

Not documented in medical record

Gleason Tertiary Pattern not assessed or unknown if assessed

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00580: Prostate (2018+)

Number of Cores Positive and Examined

Definition

These two data items record the number of positive and examined cores that are microscopically

confirmed. A diagnostic procedure, such as a needle core biopsy, can take as many as 20 or more core

biopsies to determine the extent of the cancer within the prostate.

Together these two data items can provide researchers with a surrogate estimate of the percentage of

the prostate involved by tumor, if that figure is not stated in the pathology report

Number of Cores Positive must ALWAYS be less than or equal to Number of Cores Examined.

For Prostate, there are 2 data items that record information on the number of cores positive and

examined. These data items should be coded from the same test.

3897: Number of Cores Examined

3898: Number of Cores Positive

Note: Do not make assumptions about the number of cores positive or examined based on the

number of areas biopsied within the prostate (laterality, lobes, apex, base, or mid-prostate). Several

cores may be taken from each area.

Additional Information

Clinical: pathology reports from needle biopsies or transurethral resection of prostate/bladder

that contains prostate tissue

For further information, refer to the Prostate cancer protocol published by the College of

American Pathologists for the AJCC Staging System Prostate

Source documents: pathology reports from core needle biopsies

Other names for procedures: needle core biopsy, needle biopsy, core biopsy, prostate biopsy,

sextant biopsy, transrectal biopsy, ultrasound-guided biopsy, transperineal prostate biopsy,

triggered-needle biopsy.

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00580: Prostate (2018+)

3898: Number of Cores Positive

Item Length: 2

NAACCR Item #: 3898

XML Parent-NAACCR ID: Tumor-numberOfCoresPositive

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

This data item represents the number of positive cores documented in the pathology report from

needle biopsy of the prostate gland.

Rationale

Number of Cores Positive is a Registry Data Collection Variable for AJCC. This data item was previously

collected as Prostate, CS SSF #12.

Coding guidelines

Code 00 for all cores negative

Code the exact number of positive cores 01-99

Code X1 for 100 or more positive cores

Code X6 for positive cores, unknown how many

Code X9 when

o Not documented in the medical record

o Cores not evaluated (assessed)

o Unknown if Cores evaluated (assessed)

See Number of Cores Positive and Examined for additional information.

Coding Instructions and Codes

Note 1: Physician statement of Number of Cores Positive can be used to code this data item when there

is no other information available.

Note 2: Record the number of positive prostate core biopsies from the first prostate core biopsy

diagnostic for cancer. If positive cores are identified and the number of positive cores not specifically

documented, code X6.

Information from the first core biopsy is preferred since the physician is usually examining the

entire prostate. If a second core biopsy is done, this is usually done on a specified area, so more

cores will be found to be positive

Note 3: If the pathology report contains a summary of the number of cores positive and examined, use

the summary provided. If Summary Report is not available and multiple biopsy cores are obtained on

the same day, the number of cores examined should be added.

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Do not include cores of other area like seminal vesicles

Information from the gross description of the core biopsy pathology report can be used to code

this data item when the gross findings provide the actual number of cores and not pieces, chips,

fragments, etc.

Note 4: Transperineal template-guided saturation biopsy (TTSB) is a stereotactic prostate biopsy

technique that typically produces 30 to 80 core biopsies. This is an alternative biopsy technique used for

some high-risk patients including men with persistently elevated PSA, those who have atypia on prior

prostate biopsies, or men with biopsies showing high grade prostatic intraepithelial neoplasia (PIN).

Note 5: The number of cores examined is recorded in 3897: Number of Cores Examined.

Code Description

00 All examined cores negative

01-99 1 - 99 cores positive

(Exact number of cores positive)

X1 100 or more cores positive

X6 Biopsy cores positive, number unknown

X7 No needle core biopsy performed

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit

error.)

Not documented in medical record

Number of Cores Positive not assessed or unknown if assessed

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00580: Prostate (2018+)

3897: Number of Cores Examined

Item Length: 2

NAACCR Item #: 3897

XML Parent-NAACCR ID: Tumor-numberOfCoresExamined

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00580: Prostate (2018+)

Description

This data item represents the number of cores examined as documented in the pathology report from

needle biopsy of the prostate gland.

Rationale

Number of Cores Examined is a Registry Data Collection Variable for AJCC. This data item was previously

collected as Prostate, CS SSF #13.

Coding guidelines

Code the exact number of examined cores 01-99

Code X1 for 100 or more examined cores

Code X6 for examined cores, unknown how many

Code X9 when

o Not documented in the medical record

o Cores not evaluated (assessed)

o Unknown if Cores evaluated (assessed)

See Number of Cores Positive and Examined for additional information.

Coding Instructions and Notes

Note 1: Physician statement of Number of Cores Examined can be used to code this data item when

there is no other information available.

Note 2: Record the number of prostate core biopsies examined from the first prostate core biopsy

diagnostic for cancer. If the number of cores examined is not specifically documented, code X6.

Information from the first core biopsy is preferred since the physician is usually examining the

entire prostate. If a second core biopsy is done, this is usually done on a specified area, so more

cores will be found to be positive

Note 3: If the pathology report contains a summary of the number of cores positive and examined, use

the summary provided. If Summary Report is not available and multiple biopsy cores are obtained on

the same day, the number of cores examined should be added.

Do not include cores of other area like seminal vesicles

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Information from the gross description of the core biopsy pathology report can be used to code

this data item when the gross findings provide the actual number of cores and not pieces, chips,

fragments, etc.

Note 4: Transperineal template-guided saturation biopsy (TTSB) is a stereotactic prostate biopsy

technique that typically produces 30 to 80 core biopsies. This is an alternative biopsy technique used for

some high-risk patients including men with persistently elevated PSA, those who have atypia on prior

prostate biopsies, or men with biopsies showing high grade prostatic intraepithelial neoplasia (PIN).

Note 5: The number of cores positive is recorded in 3898: Number of Cores Positive.

Code

Description

99 cores

examined

(Exact number of cores examined)

100 or more cores examined

Biopsy cores examined, number unknown

X7 No needle core biopsy performed

X8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code X8 may result in an edit

error.)

Not documented in medical record

Number of cores examined not assessed or unknown if assessed

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00590: Testis (2018+)

Testis Serum Markers and S Category

In addition to T, N, and M, the S category is collected to stage Testicular cancers. There are three factors

that make up the S stage: alpha-fetoprotein (AFP), beta-human chorionic gonadotropin (beta-hCG), and

lactase dehydrogenase (LDH). These play an important role as serum tumor markers in the staging and

monitoring of germ cell tumors and should be measured prior to removing the involved testicle. For

patients with nonseminomas, the degree of tumor-marker elevation after the cancerous testicular has

been removed is one of the most significant predictors of prognosis. Serum tumor markers are also very

useful for monitoring all stages of nonseminomas and for monitoring metastatic seminomas because

elevated marker levels are often the earliest sign of relapse.

There are several data items related to the collection of these variables.

For clinical staging

3807: AFP Pre-Orchiectomy Lab Value

3808: AFP Pre-Orchiectomy Range

3848: hCG Pre-Orchiectomy Lab Value

3849: hCG Pre-Orchiectomy Range

3868: LDH Pre-Orchiectomy Range

3923: S Category Clinical

For pathological staging

3805: AFP Post-Orchiectomy Lab Value

3806: AFP Post-Orchiectomy Range

3846: hCG Post-Orchiectomy Lab Value

3847: hCG Post-Orchiectomy Range

3867: LDH Post-Orchiectomy Range

3924: S Category Pathological

In Collaborative Stage v2 (CSv2), the “ranges” were used to derive the S category. New data items for

AJCC 8

edition is for the assignment of the S category in addition to collecting the individual data items.

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00590: Testis (2018+)

Alpha-fetoprotein (AFP) (Testis)

Definition

Alpha-fetoprotein (AFP) is a protein normally made by immature liver cells in the fetus. In adults, high

AFP levels (> 500 ng/ml) in the blood occur only in hepatocellular carcinoma (>1000), liver metastases

(from a primary elsewhere), and germ cell tumors of the testes and ovaries. Elevated AFP values are

found in non-seminomatous malignancies and mixed tumors of the testis. AFP is used with HCG to

identify the specific cell type of testicular cancer. AFP is not secreted by pure seminoma or teratoma. If

AFP > 500 ng/ml, the underlying condition is unlikely to be benign. If AFP > 10,000 ng/ml at diagnosis,

the patient is likely to have a poor prognosis.

AFP is more useful in monitoring response to therapy than making a diagnosis. The half-life of AFP is 5 to

7 days. After orchiectomy, the AFP should fall to < 25 ng/ml in 25-35 days. If elevated AFP persists, this is

an indication of residual tumor.

For Testis, there are 4 data items that record information on AFP for Testis.

3805: AFP Post-Orchiectomy Lab Value

3806: AFP Post-Orchiectomy Range

3807: AFP Pre-Orchiectomy Lab Value

3808: AFP Pre-Orchiectomy Range

Coding guidelines

Assign the code for the highest AFP value and corresponding AFP range prior to orchiectomy. In the

event an orchiectomy is not performed, or systemic treatment precedes an orchiectomy, code the

highest AFP value and corresponding range prior to any systemic treatment. The AFP Range is a category

used to group the lab values into 3 ranges: 1, 2, and 3. The pre-orchiectomy AFP lab value and the pre-

orchiectomy AFP range should be from the same test. If the clinician states an S value rather than a lab

value, code unknown (code XXXX.9) for the AFP pre-orchiectomy lab value and unknown (code 9) for the

AFP pre-orchiectomy range.

Categories used for Pre- and Post-Orchiectomy AFP Range are:

Code Description

0 Within normal limits

1 Above normal and less than 1,000 nanograms/milliliter (ng/mL)

2 1,000 -10,000 ng/mL

3 Greater than 10,000 ng/mL

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Examples for AFP Pre-Orchiectomy and AFP Post-Orchiectomy Lab Value and Range

For these examples, the lab’s normal reference range for AFP = 0-10 ng/ml

Examples Lab Value Code Range Code

1 ng/ml 1.0 0

270 ug/l 270.0

(ng/ml = ug/L)

5500 ng/ml 5500.0 2

12,500 ng/ml 12500.0 3

110,000 ng/ml XXXXX.1 3

Physician states “AFP elevated,” but no value

documented

XXXXX.9 4

S value stated (no other information available) XXXXX.9 9

No AFP test done, or unknown if done XXXXX.9 9

Additional Information

o Source documents: clinical laboratory report (blood serum radioimmunoassay or enzyme assay

(EIA)); sometimes in history and physical or clinical statement in pathology report

o For further information, refer to the Testis cancer protocol published by the College of American

Pathologists for the AJCC Staging System Testis

o Other names: FP, aFP, Alpha Fetoprotein, Alpha-fetoprotein, -fetoprotein; fetal alpha

globulin

o Normal Reference Range: Adult men 0-15 ng/ml (SI: 0-15 µg/L)

o Measurements: micrograms/liter (µg/L or ug/L) is equivalent to nanograms per milliliter (ng/ml)

o If measurements are given in IU/ml, use the following conversion:

1 ng/mL = 0.83 IU/mL

To calculate ng from IU/mL, divide the value for IU by 0.83.

Example: 10 IU/mL: 10/0.83 = 12.04 ng/mL; 5 IU/mL: 5/0.83= 6.02

ng/mL

Return to Schema ID Table

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3807: AFP Pre-Orchiectomy Lab Value

Item Length: 7

NAACCR Item #: 3807

XML Parent-NAACCR ID: Tumor-afpPreOrchiectomyLabValue

NAACCR Alternate Name: AFP (Alpha Fetoprotein) Pre-Orchiectomy Lab Value

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

AFP (Alpha Fetoprotein) Pre-Orchiectomy Lab Value refers to the AFP value measured prior to

treatment. AFP is a tumor marker that is often elevated in patients with nonseminomatous germ cell

tumors of the testis.

Rationale

AFP (Alpha Fetoprotein) Pre-Orchiectomy Lab Value is a Registry Data Collection Variable in AJCC. It was

previously collected as Testis CS SSF #6.

See Alpha-fetoprotein (AFP) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the AFP (Alpha Fetoprotein) Pre-Orchiectomy Lab Value can be used to

code this data item when no other information is available.

Note 2: Record the lab value of the highest AFP test result documented in the medical record prior to

orchiectomy or prior to any systemic treatment. The lab value may be documented in a lab report,

history and physical, or clinical statement in the pathology report.

Note 3: A lab value expressed in micrograms/liter (ug/l) is equivalent to the same value expressed in

ng/mL.

Note 4: If the lab value is expressed in IU/ml, use the following conversion: 1 ng/mL = 0.83 IU/mL.

o To calculate ng from IU/mL, divide the value for IU by 0.83.

o Example: 10 IU/mL: 10/0.83 = 12.04 ng/mL; 5 IU/mL: 5/0.83= 6.02 ng/mL

Note 5: The same laboratory test should be used to record information in 3808: AFP Pre-Orchiectomy

Range.

Code Description

0.0 0.0 nanograms/milliliter (ng/mL)

0.1-

99999.9

0.1 – 99,999.9 ng/mL

XXXXX.1 100,000 ng/mL or greater

XXXXX.7 Test ordered, results not in chart

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Code Description

XXXXX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XXXXX.8 may result

in an edit error.)

XXXXX.9 Not documented in medical record

AFP (Alpha Fetoprotein) Pre-Orchiectomy Lab Value not assessed or unknown if

assessed

Return to Schema ID Table

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00590: Testis (2018+)

3808: AFP Pre-Orchiectomy Range

Item Length: 1

NAACCR Item #: 3808

XML Parent-NAACCR ID: Tumor-afpPreOrchiectomyRange

NAACCR Alternate Name: AFP (Alpha Fetoprotein) Pre-Orchiectomy Range

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

AFP (Alpha Fetoprotein) Pre-Orchiectomy Range identifies the range category of the highest AFP value

measured prior to treatment. AFP is a serum tumor marker that is often elevated in patients with

nonseminomatous germ cell tumors of the testis.

Rationale

AFP (Alpha Fetoprotein) is a Registry Data Collection Variable in AJCC. AFP (Alpha Fetoprotein) Pre-

Orchiectomy Range is used to assign the S Category Clinical and was previously collected as Testis CS SSF

#7.

See Alpha-fetoprotein (AFP) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the AFP (Alpha Fetoprotein) Pre-Orchiectomy Range can be used to code

this data item when no other information is available.

Note 2: Record the range of the highest AFP test result documented in the medical record prior to

orchiectomy or prior to any systemic treatment. The lab value may be documented in a lab report,

history and physical, or clinical statement in the pathology report.

Note 3: A lab value expressed in micrograms/liter (ug/L) is equivalent to the same value expressed in

nanograms/milliliter (ng/mL).

Note 4: If the lab value is expressed in IU/ml, use the following conversion: 1 ng/mL = 0.83 IU/mL.

o To calculate ng from IU/mL, divide the value for IU by 0.83.

o Example: 10 IU/mL: 10/0.83 = 12.04 ng/mL; 5 IU/mL: 5/0.83= 6.02 ng/mL

Note 5: The same laboratory test should be used to record information in 3807: AFP Pre-Orchiectomy

Lab Value.

Code Description

Within normal limits

Above normal and less than 1,000 nanograms/milliliter (ng/mL)

2 1,000 -10,000 ng/mL

3 Greater than 10,000 ng/mL

344 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Code Description

4 Pre-Orchiectomy alpha fetoprotein (AFP) stated to be elevated

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

AFP (Alpha Fetoprotein) Pre-Orchiectomy Range not assessed or unknown if assessed

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3805: AFP Post-Orchiectomy Lab Value

Item Length: 7

NAACCR Item #: 3805

XML Parent-NAACCR ID: Tumor-afpPostOrchiectomyLabValue

NAACCR Alternate Name: AFP (Alpha Fetoprotein) Post-Orchiectomy Lab Value

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

AFP (Alpha Fetoprotein) Post-Orchiectomy Lab Value refers to the lowest AFP value measured post-

orchiectomy. AFP is a serum tumor marker that is often elevated in patients with nonseminomatous

germ cell tumors of the testis. The Post-Orchiectomy lab value is used to monitor response to therapy.

Rationale

AFP (Alpha Fetoprotein) Post-Orchiectomy Lab Value is a Registry Data Collection Variable in AJCC. It

was previously collected as Testis CS SSF #12.

See Alpha-fetoprotein (AFP) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the AFP (Alpha Fetoprotein) Post-Orchiectomy Lab Value can be used to

code this data item when no other information is available.

Note 2: Record the lab value of the AFP test results documented in the medical record after

orchiectomy but prior to adjuvant therapy. The lab value may be documented in a lab report, history

and physical, or clinical statement in the pathology report.

Note 3: If the initial post-orchiectomy AFP remains elevated, review subsequent tests and record the

lowest AFP value (normalization or plateau) prior to adjuvant therapy or before the value rises again.

Note 4: A lab value expressed in micrograms/liter (ug/L) is equivalent to the same value expressed in

ng/mL.

Note 5: If the lab value is expressed in IU/ml, use the following conversion: 1 ng/mL = 0.83 IU/mL.

o To calculate ng from IU/mL, divide the value for IU by 0.83.

o Example: 10 IU/mL: 10/0.83 = 12.04 ng/mL; 5 IU/mL: 5/0.83= 6.02 ng/mL

Note 6: If the pre-orchiectomy AFP was normal, a post-orchiectomy AFP may not be performed. In this

case, code XXXXX.9 should be recorded.

Note 7: If the only information available is a statement of elevated or normal, code XXXXX.9.

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Note 8: The same laboratory test should be used to record information in 3806: AFP Post-Orchiectomy

Range.

Code Description

0.0 0.0 nanograms/milliliter (ng/mL)

0.1-

99999.9

0.1 – 99,999.9 ng/mL

XXXXX.1 100,000 ng/mL or greater

XXXXX.7 Test ordered, results not in chart

XXXXX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XXXXX.8 may result

in an edit error.)

XXXXX.9 Not documented in medical record

No orchiectomy performed

AFP (Alpha Fetoprotein) Post-Orchiectomy Lab Value not assessed or unknown if

assessed

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3806: AFP Post-Orchiectomy Range

Item Length: 1

NAACCR Item #: 3806

XML Parent-NAACCR ID: Tumor-afpPostOrchiectomyRange

NAACCR Alternate Name: AFP (Alpha Fetoprotein) Post-Orchiectomy Range

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

AFP (Alpha Fetoprotein) Post-Orchiectomy Range identifies the range category of the lowest AFP value

measured post-orchiectomy. AFP is a serum tumor marker that is often elevated in patients with

nonseminomatous germ cell tumors of the testis. The Post-Orchiectomy lab value is used to monitor

response to therapy.

Rationale

AFP (Alpha Fetoprotein) Post-Orchiectomy Range is a Registry Data Collection Variable in AJCC. AFP

(Alpha Fetoprotein) Post-Orchiectomy Range is used to assign the S Category Pathological and was

previously collected as Testis CS SSF #13.

See Alpha-fetoprotein (AFP) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the AFP (Alpha Fetoprotein) Post-Orchiectomy Range can be used to

code this data item when there is no other information available.

Note 2: Record the range of the AFP test as documented in the medical record after orchiectomy but

prior to adjuvant therapy. The lab value may be documented in a lab report, history and physical, or

clinical statement in the pathology report.

Note 3: If the initial post-orchiectomy AFP remains elevated, review subsequent tests and record the

lowest AFP value (normalization or plateau) prior to adjuvant therapy or before the value rises again.

Note 4: A lab value expressed in micrograms/liter (ug/L) is equivalent to the same value expressed in

nanograms/milliliter (ng/mL).

Note 5: If the lab value is expressed in IU/ml, use the following conversion: 1 ng/mL = 0.83 IU/mL.

o To calculate ng from IU/mL, divide the value for IU by 0.83.

o Example: 10 IU/mL: 10/0.83 = 12.04 ng/mL; 5 IU/mL: 5/0.83= 6.02 ng/mL

Note 6: If the pre-orchiectomy AFP was normal, a post-orchiectomy AFP may not be performed. In this

case, code 5 should be recorded.

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Note 7: The same laboratory test should be used to record information in 3805: AFP Post-Orchiectomy

Lab Value.

Code Description

0 Within normal limits

1 Above normal and less than 1,000 nanograms/milliliter (ng/mL)

2 1,000 -10,000 ng/mL

3 Greater than 10,000 ng/mL

4 Post-Orchiectomy alpha fetoprotein (AFP) stated to be elevated

5 Post-Orchiectomy alpha fetoprotein (AFP) unknown or not done but pre-orchiectomy AFP was

normal

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

No orchiectomy performed

AFP (Alpha Fetoprotein) Post-Orchiectomy Range not assessed or unknown if assessed

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Human Chorionic Gonadotropin (hCG) (Testis)

Definition

Human chorionic gonadotropin (hCG) is a hormone produced by the placenta and some germ cell

tumors. Two subunits, alpha and beta, can be measured in blood or serum. The alpha subunit is a non-

specific marker for pancreatic and pituitary tumors. Beta-hCG levels are never found in normal healthy

men. When the presence of beta-hCG is detected in serum, it always indicates a malignancy. Beta-hCG is

secreted by some non- seminomatous germ cell tumors and mixed tumors and is used with AFP to

identify the specific cell type of testicular cancer. Beta-hCG is also useful in monitoring response to

therapy. After orchiectomy, the hCG should be undetectable within 5 to 8 days. If elevated hCG persists,

this is an indication of residual tumor.

For Testis, there are 4 data items that record information on hCG.

3846: hCG Post-Orchiectomy Lab Value

3847: hCG Post-Orchiectomy Range

3848: hCG Pre-Orchiectomy Lab Value

3849: hCG Pre-Orchiectomy Range

Coding Guidelines

hCG Pre-Orchiectomy Lab Value and Range

Assign the code for the highest hCG value and corresponding hCG range prior to orchiectomy. In

the event an orchiectomy is not performed, or systemic treatment precedes an orchiectomy,

code the highest hCG value and corresponding range prior to any systemic treatment. The hCG

Range is a category used to group the lab values into 3 ranges: 1, 2, and 3. The pre-orchiectomy

hCG lab value and the pre-orchiectomy hCG range should be from the same test. If the clinician

states an S value rather than a lab value, code unknown (code XXXX.9) for the hCG pre-

orchiectomy lab value and unknown (code 9) for the hCG pre-orchiectomy range.

hCG Post-Orchiectomy Lab Value and Range

Assign the code for the lowest hCG value and corresponding hCG range after orchiectomy but

prior to adjuvant treatment. The half-life of human chorionic gonadotropic is 1 to 3 days, but it

may take much longer for this tumor marker to return to normal. If the first post-orchiectomy

hCG remains elevated, continue reviewing subsequent lab work and record the lowest hCG

value (normalization or plateau) prior to adjuvant treatment or before the value rises again. The

hCG Range is a category used to group the lab values into 3 ranges: 1, 2, and 3. The post-

orchiectomy hCG lab value and the post-orchiectomy hCG range should be from the same test.

If the clinician states an S value rather than a lab value, code unknown (code XXXX.9) for the

hCG post-orchiectomy lab value and unknown (code 9) for the hCG post-orchiectomy range.

350 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Categories used for Pre- and Post-Orchiectomy hCG Range are:

Code Description

0 Within normal limits

1 Above normal and less than 5,000 milli-International Units/milliliter (mIU/mL)

2 5,000 - 50,000 mIU/mL

3 Greater than 50,000 mIU/mL

Examples for hCG Pre-Orchiectomy and hCG Post-Orchiectomy Lab Value and Range

For these examples, the lab’s normal reference range for hCG = 0-5 mIU/mL

Examples Lab Value Code Range Code

2.0 mIU/mL 2.0 0

412 mIU/mL 412.0 1

6213 mIU/mL 6213.0 2

14,724 mIU/mL

14724.0

108,325 mIU/mL

XXXXX.1

Physician states “hCG elevated,” but no value documented XXXXX.9 4

S value stated (no other information available) XXXXX.9 9

No AFP test done, or unknown if done XXXXX.9 9

Additional Information

Source documents: clinical laboratory report (blood or serum test), sometimes in history and

physical or clinical statement in pathology report

For further information, refer to the Testis cancer protocol published by the College of American

Pathologists for the AJCC Staging System Testis

Other names: Human chorionic gonadotropin, b-hCG, beta subunit HCG, beta hCG, -hCG

Normal Reference Range

o < 2 ng/ml (SI: < 2 µg/L or < 2 ug/L) 1 ng/ml of HCG is approximately 5 mIU/ml.

o < 5 mIU/mL (< 5 IU/L) To record mIU/mL in ng/ml, divide the test result by 5.

Measurements: International Units/liter (IU/L) is equivalent to milli-International Units per

milliliter (mIU/ml)

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3848: hCG Pre-Orchiectomy Lab Value

Item Length: 7

NAACCR Item #: 3848

XML Parent-NAACCR ID: Tumor-hcgPreOrchiectomyLabValue

NAACCR Alternate Name: hCG (Human Chorionic Gonadotropin) Pre-Orchiectomy Lab Value

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

hCG (Human Chorionic Gonadotropin) Pre-Orchiectomy Lab Value refers to the hCG value measured

prior to treatment. hCG is a serum tumor marker that is often elevated in patients with

nonseminomatous germ cell tumors of the testis.

Rationale

hCG (Human Chorionic Gonadotropin) Pre-Orchiectomy Lab Value is a Registry Data Collection Variable

in AJCC. It was previously collected as Testis CS SSF #8.

See Human Chorionic Gonadotropin (hCG) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the hCG (Human Chorionic Gonadotropin) Pre-Orchiectomy Lab Value

can be used to code this data item when no other information is available.

Note 2: Record the lab value of the highest hCG test result documented in the medical record prior to

orchiectomy or prior to any systemic treatment. The lab value may be documented in a lab report,

history and physical, or clinical statement in the pathology report.

Note 3: A lab value expressed in International Units/liter (IU/L) is equivalent to the same value

expressed in milli-International Units/milliliter (mIU/mL).

Note 4: The same laboratory test should be used to record information in 3849: hCG Pre-Orchiectomy

Range.

Code Description

0.0 0.0 milli-International Units/milliliter (mIU/mL)

0.1-99999.9 0.1 – 99,999.9 mIU/mL

XXXXX.1 100,000 mIU/mL or greater

XXXXX.7 Test ordered, results not in chart

XXXXX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XXXXX.8 may result

in an edit error.)

XXXXX.9 Not documented in medical record

hCG (Human Chorionic Gonadotropin) Pre-orchiectomy Lab Value not assessed or

unknown if assessed

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3849: hCG Pre-Orchiectomy Range

Item Length: 1

NAACCR Item #: 3849

XML Parent-NAACCR ID: Tumor-hcgPreOrchiectomyRange

NAACCR Alternate Name: hCG

Schema(s):

00590: Testis (2018+)

Description

Human Chorionic Gonadotropin (hCG) Pre-Orchiectomy Range identifies the range category of the

highest hCG value measured prior to treatment. hCG is a serum tumor marker that is often elevated in

patients with nonseminomatous germ cell tumors of the testis.

Rationale

hCG (Human Chorionic Gonadotropin) is a Registry Data Collection Variable in AJCC. hCG (Human

Chorionic Gonadotropin) Pre-Orchiectomy Range is used to assign the S Category Clinical and was

previously collected as Testis CS SSF #9.

See Human Chorionic Gonadotropin (hCG) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the hCG (Human Chorionic Gonadotropin) Pre-Orchiectomy Range can

be used to code this data item when no other information is available.

Note 2: Record the range of the highest hCG test result documented in the medical record prior to

orchiectomy or prior to any systemic treatment. The lab value may be documented in a lab report,

history and physical, or clinical statement in the pathology report.

Note 3: A lab value expressed in International Units/liter (IU/L) is equivalent to the same value

expressed in milli-International Units/milliliter (mIU/mL).

Note 4: The same laboratory test should be used to record information in 3848: hCG Pre-Orchiectomy

Lab Value.

Code Description

0 Within normal limits

1 Above normal and less than 5,000 milli-International Units/milliliter (mIU/mL)

2 5,000 - 50,000 mIU/mL

3 Greater than 50,000 mIU/mL

4 Pre-orchiectomy human chorionic gonadotropin (hCG) stated to be elevated

7 Test ordered, results not in chart

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

Not documented in medical record

hCG pre-orchiectomy range not assessed or unknown if assessed

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3846: hCG Post-Orchiectomy Lab Value

Item Length: 7

NAACCR Item #: 3846

XML Parent-NAACCR ID: Tumor-hcgPostOrchiectomyLabValue

NAACCR Alternate Name: hCG (Human Chorionic Gonadotropin) Post-Orchiectomy Lab Value

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

hCG (Human Chorionic Gonadotropin) Post-Orchiectomy Lab Value refers to the lowest hCG value

measured post-orchiectomy. hCG is a serum tumor marker that is often elevated in patients with

nonseminomatous germ cell tumors of the testis. The Post-Orchiectomy lab value is used to monitor

response to therapy.

Rationale

hCG (Human Chorionic Gonadotropin) Post-Orchiectomy Lab Value is a Registry Data Collection Variable

in AJCC. It was previously collected as Testis CS SSF #14.

See Human Chorionic Gonadotropin (hCG) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the hCG (Human Chorionic Gonadotropin) Post-Orchiectomy Lab Value

can be used to code this data item when no other information is available.

Note 2: Record the value of the hCG test as documented in the medical record after orchiectomy but

prior to adjuvant therapy. The lab value may be documented in a lab report, history and physical, or

clinical statement in the pathology report.

Note 3: If the initial post-orchiectomy hCG remains elevated, review subsequent tests and record the

lowest hCG value (normalization or plateau) prior to adjuvant therapy or before the value rises again.

Note 4: A lab value expressed in International Units/liter (IU/L) is equivalent to the same value

expressed in milli-International Units/milliliter (mIU/mL).

Note 5: If the pre-orchiectomy hCG was normal, a post-orchiectomy hCG may not be performed. In this

case, code XXXXX.9 should be recorded.

Note 6: If the only information available is a statement of elevated or normal, code XXXXX.9.

Note 7: The same laboratory test should be used to record information in 3847: hCG Post-Orchiectomy

Range.

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Code Description

0.0 0.0 milli-International Units/milliliter (mIU/mL)

0.1

99999.9

0.1

–

99,999.9 mIU/mL

XXXXX.1 100,000 mIU/mL or greater

XXXXX.7 Test ordered, results not in chart

XXXXX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XXXXX.8 may result

in an edit error.)

XXXXX.9 Not documented in medical record

No orchiectomy performed

hCG (Human Chorionic Gonadotropin) Post-orchiectomy Lab Value not assessed or

unknown if assessed

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3847: hCG Post-Orchiectomy Range

Item Length: 1

NAACCR Item #: 3847

XML Parent-NAACCR ID: Tumor-hcgPostOrchiectomyRange

NAACCR Alternate Name: hCG (Human Chorionic Gonadotropin) Post-Orchiectomy Range

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

Human Chorionic Gonadotropin (hCG) Post-Orchiectomy Range identifies the range category of the

lowest hCG value measured post-orchiectomy. hCG is a serum tumor marker that is often elevated in

patients with nonseminomatous germ cell tumors of the testis. The Post-Orchiectomy lab value is used

to monitor response to therapy.

Rationale

hCG (Human Chorionic Gonadotropin) is a Registry Data Collection Variable in AJCC. hCG (Human

Chorionic Gonadotropin) Post-orchiectomy Range is used to assign the S Category Pathological and was

previously collected as Testis CS SSF #15.

See Human Chorionic Gonadotropin (hCG) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the hCG (Human Chorionic Gonadotropin) Post-orchiectomy Range can

be used to code this data item when there is no other information available.

Note 2: Record the range of the hCG test as documented in the medical record after orchiectomy but

prior to adjuvant therapy. The lab value may be documented in a lab report, history and physical, or

clinical statement in the pathology report.

Note 3: If the initial post-orchiectomy hCG remains elevated, review subsequent tests and record the

lowest hCG value (normalization or plateau) prior to adjuvant therapy or before the value rises again.

Note 4: A lab value expressed in International Units/liter (IU/L) is equivalent to the same value

expressed in milli-International Units/milliliter (mIU/mL).

Note 5: If the pre-orchiectomy hCG was normal, a post-orchiectomy hCG may not be performed. In this

case, code 5 should be recorded.

Note 6: The same laboratory test should be used to record information in 3846: hCG Post-Orchiectomy

Lab Value.

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Code Description

0 Within normal limits

1 Above normal and less than 5,000 milli-International Units/milliliter (mIU/mL)

2 5,000 - 50,000 mIU/mL

3 Greater than 50,000 mIU/mL

4 Post-orchiectomy human chorionic gonadotropin (hCG) stated to be elevated

Post

Orchiectomy human chorionic gonadotropin (hCG) unknown or not done but pre

orchiectomy hCG was normal

Test ordered, results not in chart

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

No orchiectomy performed

hCG (Human Chorionic Gonadotropin) Post-orchiectomy Range not assessed or unknown if

assessed

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Lactate Dehydrogenase (LDH) (Testis)

Definition

When cells (normal or tumor) are damaged or destroyed, an enzyme called lactate dehydrogenase (LDH)

is released into the bloodstream. LDH is an indirect indication of possible tumor burden or damage to

an organ, which may be caused by metastatic involvement of liver or lung, or a myocardial

infarction. The total LDH should be the test value that is coded, but there are five fractions of LDH that

measure tissue specific cellular damage: LD1 and LD2: heart, red blood cells and kidneys; LD3: lung; LD4

and LD5: liver, skin and skeletal muscles. LDH is elevated in 60% of patients with non-seminomatous

germ cell tumors of the testis. LDH is not a screening test, nor is it diagnostic of melanoma, ocular

adnexal lymphoma, or testicular cancer.

For testis, only the LDH Range is coded. LDH is non-specific for testicular cancer. Although part of the

criteria for the S category in the TNM system, LDH is not routinely performed unless the patient has

evidence of bulky or distant disease.

For Testis, there are 2 data items that record information on LDH.

3867: LDH Post-Orchiectomy Range

3868: LDH Pre-Orchiectomy Range

Coding guidelines

LDH Pre-Orchiectomy Range

The LDH Range is a category used to group the lab values into 3 ranges: 1, 2, and 3. Code the range of

the highest LDH value prior to orchiectomy, based on the reference range used by the lab. In the event

an orchiectomy is not performed, or systemic treatment precedes an orchiectomy, code the range of

the highest LDH value prior to any systemic treatment. If the clinician states an S value rather than a lab

value, code unknown (code 9).

LDH Post-Orchiectomy Range

Code the range of the lowest LDH after orchiectomy but prior to adjuvant treatment. If the first post-

orchiectomy LDH remains elevated, continue reviewing subsequent lab work and record the lowest LDH

value (normalization or plateau) prior to adjuvant treatment or before the value rises again. If the

clinician states an S value rather than a lab value, code unknown (code 9).

Categories used for Pre- and Post-Orchiectomy LDH Range are:

Code Description

0 Within normal limits

Less than 1.5 x N

(Less than 1.5 times the upper limit of normal for LDH)

1.5 to 10 x N

(Between 1.5 and 10 times the upper limit of normal for LDH)

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Code Description

3 Greater than 10 x N

(Greater than 10 times the upper limit of normal for LDH)

To calculate whether the lab result is in a particular range, multiply the lab’s upper limit of normal

(usually stated on the report) times the stated multiplier. If the test is elevated, determine whether it is

less than 1.5 times the upper limit of normal (code 1), between 1.5 and 10 times the upper limit of

normal (code 2), or more than 10 times the upper limit of normal (code 3).

Examples for LDH Pre-Orchiectomy and Post-Orchiectomy Range

For these examples, the lab’s normal reference range for LDH = 100-225

o 1.5 X 225 (upper limit of normal) = 337.5

o 10 x 225 (upper limit of normal) = 2250

Therefore, for this lab, a value that is elevated and up to 337 = code 1, a value from 338 to 2250 = code

2, and a value greater than 2250 = code 3.

Examples Code

118

(within normal range 100-225)

282

(elevated but less than 337.5)

1081

(elevated and between 337.5 and 2250)

2795

(elevated and greater than 2250)

Physician states “LDH elevated,” but no value documented 4

No LDH test done, or unknown if done 9

S value stated (no other information available) 9

Additional Information

Source documents: clinical laboratory report; may be included in a liver or hepatic panel/profile,

a cardiac panel, or a general metabolic panel of tests

For further information, refer to the Testis cancer protocol published by the College of American

Pathologists for the AJCC Staging System Testis

Other names: LD, Lactate dehydrogenase, lactase dehydrogenase, lactic acid dehydrogenase

Normal reference range: varies widely by laboratory, patient age, and the units of

measurement.

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00590: Testis (2018+)

3868: LDH Pre-Orchiectomy Range

Item Length: 1

NAACCR Item #: 3868

XML Parent-NAACCR ID: Tumor-ldhPreOrchiectomyRange

NAACCR Alternate Name: LDH (Lactate Dehydrogenase) Pre-Orchiectomy Range

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

Lactate Dehydrogenase (LDH) Range identifies the range category of the highest LDH value measured

prior to treatment. LDH is a nonspecific marker for testicular cancer that is elevated in some germ cell

tumors. This data item refers to the Pre-Orchiectomy range.

Rationale

LDH (Lactate Dehydrogenase) is a Registry Data Collection Variable in AJCC. LDH (Lactate

Dehydrogenase) Pre-Orchiectomy Range is used to assign the S Category Clinical and was previously

collected as Testis CS SSF #10.

See Lactate Dehydrogenase (LDH) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the LDH (Lactate Dehydrogenase) Pre-Orchiectomy Range can be used to

code this data item when no other information is available.

Note 2: Record the range of the highest LDH test result documented in the medical record prior to

orchiectomy or prior to any systemic treatment. The lab value may be documented in a lab report,

history and physical, or clinical statement in the pathology report.

Note 3: Of the three tumor markers, lactate dehydrogenase (LDH) is the least specific for testicular

cancer. The magnitude of LDH elevation directly correlates with Testis tumor burden.

Code Description

0 Within normal limits

Less than 1.5 x N

(Less than 1.5 times the upper limit of normal for LDH)

1.5 to 10 x N

(Between 1.5 and 10 times the upper limit of normal for LDH)

Greater than 10 x N

(Greater than 10 times the upper limit of normal for LDH)

4 Pre-Orchiectomy lactate dehydrogenase (LDH) range stated to be elevated

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit error.)

9 Not documented in medical record

LDH (Lactate Dehydrogenase) Pre-Orchiectomy Range not assessed or unknown if assessed

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00590: Testis (2018+)

3867: LDH Post-Orchiectomy Range

Item Length: 1

NAACCR Item #: 3867

XML Parent-NAACCR ID: Tumor-ldhPostOrchiectomyRange

NAACCR Alternate Name: LDH (Lactate Dehydrogenase) Post-Orchiectomy Range

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

LDH (Lactate Dehydrogenase) Post-Orchiectomy Range identifies the range category of the lowest LDH

value measured post-orchiectomy. LDH is a nonspecific marker for testicular cancer that is elevated in

some germ cell tumors. The Post-Orchiectomy lab value is used to monitor response to therapy.

Rationale

LDH (Lactate Dehydrogenase) is a Registry Data Collection Variable in AJCC. LDH (Lactate

Dehydrogenase) Post-Orchiectomy Range is used to assign the S Category Pathological and was

previously collected as Testis CS SSF #16.

See Lactate Dehydrogenase (LDH) (Testis) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of the LDH (Lactate Dehydrogenase) Post-Orchiectomy Range can be used

to code this data item when there is no other information available.

Note 2: Record the range of the LDH test as documented in the medical record after orchiectomy but

prior to adjuvant therapy. The lab value may be documented in a lab report, history and physical, or

clinical statement in the pathology report.

Note 3: If the initial post-orchiectomy LDH remains elevated, review subsequent tests and record the

lowest LDH value (normalization or plateau) prior to adjuvant therapy or before the value rises again.

Note 4: Of the three tumor markers, lactate dehydrogenase (LDH) is the least specific for testicular

cancer. The magnitude of LDH elevation directly correlates with Testis tumor burden.

Note 5: If the pre-orchiectomy LDH was normal, a post-orchiectomy LDH may not be performed. In this

case, code 5 should be recorded.

Code Description

0 Within normal limits

Less than 1.5 x N

(Less than 1.5 times the upper limit of normal for LDH)

1.5 to 10 x N

(Between 1.5 and 10 times the upper limit of normal for LDH)

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Code Description

3 Greater than 10 x N

(Greater than 10 times the upper limit of normal for LDH)

4 Post-Orchiectomy lactate dehydrogenase (LDH) range stated to be elevated

Post

Orchiectomy lactage

dehydrogenase (LDH) unknown or not done but pre

orchiectomy

LDH was normal

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

No orchiectomy performed

LDH (Lactate Dehydrogenase) Post-Orchiectomy Range not assessed or unknown if assessed

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00590: Testis (2018+)

3923: S Category Clinical

Item Length: 1

NAACCR Item #: 3923

XML Parent-NAACCR ID: Tumor-sCategoryClinical

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

S Category Clinical combines the results of pre-orchiectomy Alpha Fetoprotein (AFP), Human Chorionic

Gonadotropin (hCG) and Lactate Dehydrogenase (LDH) into a summary S value.

Rationale

S Category Clinical is required for prognostic stage grouping in Chapter 59 Testis. It is a new data item for

cases diagnosed 1/1/2018+.

Additional Information

For further information, refer to the Testis cancer protocol published by the College of American

Pathologists for the AJCC Staging System Testis

Coding Instructions and Codes

Note 1: Code the S category as described by the physician. If the S category determined by available lab

values or calculated by vendor software differs from the physician statement of the S category, the

physician’s statement takes precedence.

Note 2: Code the pre-orchiectomy S category according to the table below. This table is also available in

AJCC 8

edition, Chapter 59, Testis.

For AFP, a lab value expressed in micrograms per liter (ug/L) is equivalent to the same value

expressed in nanograms per milliliter (ng/ml).

Note 3: Clinical stage values are those based on physician statement or lab values at diagnosis, prior to

orchiectomy, and prior to any systemic treatment.

Note 4: All three lab values are needed for S0-S1. Only one elevated test is needed to assign S2-3. If any

individual test is not available and none of the available tests results meets the S2-3 criterion for that

test, assign code 9 (SX).

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Code Description

0 S0: Marker study levels within normal levels

1 S1: At least one of these values is elevated AND

LDH less than 1.5 x N* AND

hCG (mIU/L) less than 5,000 AND

AFP (ng/mL) less than 1,000

2 S2:

LDH 1.5 x N* to 10 x N* OR

hCG (mIU/L) 5,000 to 50,000 OR

AFP (ng/mL) 1,000 to 10,000

3 S3: Only one elevated test is needed

LDH greater than 10 x N* OR

hCG (mIU/mL) greater than 50,000 OR

AFP (ng/mL) greater than 10,000

SX:

Not documented in medical record

S Category Clinical not assessed or unknown if assessed

*N indicates the upper limit of normal for the LDH assay.

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00590: Testis (2018+)

3924: S Category Pathological

Item Length: 1

NAACCR Item #: 3924

XML Parent-NAACCR ID: Tumor-sCategoryPathological

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00590: Testis (2018+)

Description

S Category Pathological combines the results of post-orchiectomy Alpha Fetoprotein (AFP), Human

Chorionic Gonadotropin (hCG) and Lactate Dehydrogenase (LDH) into a summary S value.

Rationale

S Category Pathological is required for prognostic stage grouping in AJCC 8

edition, Chapter 59 Testis. It

is a new data item for cases diagnosed 1/1/2018+.

Additional Information

For further information, refer to the Testis cancer protocol published by the College of American

Pathologists for the AJCC Staging System Testis

Coding Instructions and Codes

Note 1: Code the S category as described by the physician. If the S category determined by available lab

values or calculated by vendor software differs from the physician statement of the S category, the

physician’s statement takes precedence.

Note 2: Code the post-orchiectomy S category according to the table below. This table is also available

in AJCC 8

edition, Chapter 59, Testis.

For AFP, a lab value expressed in micrograms per liter (ug/L) is equivalent to the same value

expressed in nanograms per milliliter (ng/ml).

Note 3: Pathological stage values are those based on physician statement or lab values after

orchiectomy and prior to adjuvant therapy.

Note 4: If the initial post-orchiectomy lab values remain elevated, review the subsequent tests and use

the lowest lab values (normalization or plateau) prior to adjuvant therapy or before the value rises

again.

Note 5: All three lab values are needed for S0-S1. Only one elevated test is needed to assign S2-3. If any

individual test is not available and none of the available tests results meets the S2-3 criterion for that

test, assign code 9 (SX).

Note 6: When all the serum tumor markers are normal pre-orchiectomy and they are not repeated post-

orchiectomy, code 5.

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Code Description

0 S0: Marker study levels within normal levels

1 S1: At least one of these values is elevated AND

LDH less than 1.5 x N* AND

hCG (mIU/L) less than 5,000 AND

AFP (ng/mL) less than 1,000

2 S2

LDH 1.5 x N* to 10 x N* OR

hCG (mIU/L) 5,000 to 50,000 OR

AFP (ng/mL) 1,000 to 10,000

3 S3: Only one elevated test is needed

LDH greater than 10 x N* OR

hcG (mIU/mL) greater than 50,000 OR

AFP (ng/mL) greater than 10,000

Post

orchiectomy serum tumor markers

unknown or not done but pre

orchiectomy

serum tumor markers were normal

SX:

Not documented in medical record

S Category Pathological not assessed or unknown if assessed

*N indicates the upper limit of normal for the LDH assay.

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URINARY TRACT

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00600: Kidney Parenchyma (2018+)

3864: Invasion Beyond Capsule

Item Length: 1

NAACCR Item #: 3864

XML Parent-NAACCR ID: Tumor-invasionBeyondCapsule

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00600: Kidney (2018+)

Description

Kidney Tumor Extension pertains to the pathologically confirmed invasion of the tumor beyond the

fibrous capsule in which the kidney is enclosed.

Rationale

Kidney Tumor Extension into specific tissues for Kidney is a Registry Data Collection Variable in AJCC. It

was previously collected as Kidney, CS SSF #1.

Definition

This data item collects additional information on the description of tumor spread (invasion beyond

capsule) as documented in the pathology report. Do not include clinical findings in this field.

Coding guidelines

Code 0: There is no invasion beyond capsule

o If surgical resection is done and tumor is “confined to kidney” and staging is based on

size, then there has been no invasion through the capsule (no invasion into perinephric

fat)

Code 1: Perinephric fat, which is the layer of fat (adipose tissue) outside the renal capsule but

inside Gerota’s fascia

Code 2: Renal sinus, which is the elongated oval indentation in the renal parenchyma occupied

by the renal pelvis, renal calyces, blood vessels, nerves, and perisinus fat

o Synonyms include: renal hilum, renal sinus fat, medial invasion

Code 3: Gerota’s fascia (Gerota’s capsule), which is a fibrous envelope of tissue that surrounds

the kidney

Code 4: Any combination of codes 1-3

Code 5: Invasion beyond the capsule, NOS

Code 9 when

o There is no documentation in the medical record

o Clinical diagnosis only

o Evaluation of capsule invasion not done or unknown if done

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Additional Information

For further information, refer to the Kidney cancer protocol published by the College of

American Pathologists for the AJCC Staging System Kidney

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

is no mention of invasion beyond capsule, the registrar could assume that it was negative and

code appropriately. For the SSDI, this assumption cannot be made. There must be a statement

that invasion beyond capsule is not present to code 0.

Coding Instructions and Codes

Note 1: Physician statement of pathologically confirmed invasion of the tumor beyond the fibrous

capsule (invasion beyond capsule) can be used to code this data item.

Note 2: Information about invasion beyond the capsule is collected in primary tumor as an element in

anatomic staging. It is also collected in this field as it may have an independent effect on prognosis.

If surgical resection is done and tumor is “confined to kidney” and staging is based on size, then

there has been no invasion through the capsule (no invasion into perinephric fat)

Note 3: Perinephric/sinus fat invasion should be confirmed microscopically and is invasion into fat by

tumor cells, with or without desmoplastic reaction, and vascular invasion into perinephric/sinus soft

tissue.

Synonyms include: renal hilum, renal sinus fat, medial invasion

Note 4: Record invasion beyond capsule as documented in the pathology report.

Note 5: Do not use imaging findings to code this data item.

Note 6: Code 9 if surgical resection of the primary site is performed and there is no mention of invasion

beyond capsule.

Code Description

0 Invasion beyond capsule not identified

1 Perinephric (beyond renal capsule) fat or tissue

2 Renal sinus

3 Gerota’s fascia

4 Any combination of codes 1-3

5 Invasion beyond capsule, NOS

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Invasion beyond capsule not assessed or unknown if assessed

No surgical resection of primary site is performed

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00600: Kidney Parenchyma (2018+)

3886: Major Vein Involvement

Item Length: 1

NAACCR Item #: 3886

XML Parent-NAACCR ID: Tumor-majorVeinInvolvement

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00600: Kidney

Description

Major vein involvement pertains to the invasion of the kidney tumor into major veins.

Rationale

Involvement of major veins for Kidney is a Registry Data Collection Variable in AJCC. It was previously

collected as Kidney, CS SSF #2.

Definition

Involvement of veins from a renal cancer has prognostic implications because tumor cells can more

easily disseminate through the bloodstream. This data item records information about the presence and

level of involvement of specific major blood vessels. Do not code microscopically identified involvement

of small unnamed blood vessels within the kidney; this information is coded in the field Lymph-Vascular

Invasion (LVI). The tumor may be described as a thrombus, a cluster of tumor cells presents in the center

of the vein but not attached to the wall of the vein. Tumor spread may resemble mud extruding along

the inside of a pipe. Direct tumor invasion of the wall of the inferior vena cava is not coded in this field.

Record the code that best describes involvement of the renal vein and/or inferior vena cava (IVC) as

described in the pathology report. Do not include clinical findings in this field.

Coding guidelines

Code 0: There is no involvement of the major veins

o If surgical resection is done and tumor is “confined to kidney” and staging is based on

size, then there is no involvement of major veins

Code 1: Involvement of the renal vein or segmental branches

Code 2: Involvement of the inferior vena cava (IVC)

Code 3: Involvement of major veins, but not specified which one (renal vein, segmental

branches or inferior vena cava (IVC))

Code 4: Involvement of more than one vein (any combination of codes 1-3)

Code 9 when

o There is no documentation in the medical record

o Clinical diagnosis only

o Evaluation of major vein involvement not done or unknown if done

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Additional Information

For further information, refer to the Kidney cancer protocol published by the College of

American Pathologists for the AJCC Staging System Kidney

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of major vein involvement, the registrar could assume that it was negative and

code appropriately. For the SSDI, this assumption cannot be made. There must be a statement

that major vein involvement is not present to code 0.

Coding Instructions and Codes

Note 1: Physician statement of Major Vein Involvement can be used to code this data item. The major

veins include the renal vein or its segmental branches, and the inferior vena cava.

Note 2: Information about major vein involvement beyond the kidney is collected in primary tumor as

an element in anatomic staging. It is also collected in this field as it may have an independent effect on

prognosis.

If surgical resection is done and tumor is “confined to kidney” and staging is based on size, then

there is no involvement of major veins

Note 3: Record the involvement of specific named veins as documented in the pathology report. Do not

code invasion of small unnamed vein(s) of the type collected as lymph-vascular invasion. Lymph-vascular

invasion is usually only seen microscopically.

Note 4: Do not use imaging findings to code this data item.

Note 5: Code 9 if surgical resection of the primary site is performed and there is no mention of major

vein involvement.

Code

Description

0 Major vein involvement not present/not identified

1 Renal vein or its segmental branches

2 Inferior vena cava (IVC)

3 Major vein invasion, NOS

4 Any combination of codes 1-3

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Vein involvement not assessed or unknown if assessed

No surgical resection of primary site is performed

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00600: Kidney Parenchyma (2018+)

3861: Ipsilateral Adrenal Gland Involvement

Item Length: 1

NAACCR Item #: 3861

XML Parent-NAACCR ID: Tumor-ipsilateralAdrenalGlandInvolve

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00600: Kidney (2018+)

Description

Ipsilateral adrenal gland involvement pertains to direct extension of the tumor into the ipsilateral

adrenal gland (continuous) or ipsilateral adrenal gland involvement by a separate nodule

(discontiguous).

Rationale

Ipsilateral adrenal gland involvement for Kidney is a Registry Data Collection Variable in AJCC. It was

previously collected as Kidney, CS SSF #3.

Definition

The adrenal gland is contained within Gerota’s fascia and is contiguous with the kidney, but it has its

own lymphatic and vascular drainage systems. Involvement of the ipsilateral (same side) adrenal gland

by kidney tumor—an adverse prognostic indicator—may be by direct extension (contiguous) or

hematogenous (through the bloodstream; discontiguous). Do not include clinical findings in this field.

Coding guidelines

Code 0: There is no involvement of the ipsilateral adrenal gland

o If surgical resection is done and tumor is “confined to kidney” and staging is based on

size, then there is no involvement of the adrenal gland

Code 1: Ipsilateral adrenal gland involved by direct extension (contiguous involvement)

Code 2: Ipsilateral adrenal gland involved by separate nodule (discontiguous involvement)

Code 3: Ipsilateral adrenal gland involvement by contiguous and discontiguous involvement

Code 4: Ipsilateral adrenal gland involvement, unknown if contiguous or discontiguous

involvement

Code 9 when

o There is no documentation in the medical record

o Clinical diagnosis only

o Evaluation of ipsilateral adrenal gland involvement not done or unknown if done

Additional Information

Source documents: pathology report

For further information, refer to the Kidney cancer protocol published by the College of

American Pathologists for the AJCC Staging System Kidney

Other names: suprarenal gland; same side (ipsilateral)

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Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of ipsilateral gland involvement, the registrar could assume that it was negative

and code appropriately. For the SSDI, this assumption cannot be made. There must be a

statement that ipsilateral gland involvement is not present to code 0.

Coding Instructions and Codes

Note 1: Physician statement of Ipsilateral Adrenal Gland Involvement can be used to code this data item.

Note 2: Information about contiguous ipsilateral adrenal gland involvement is collected in primary

tumor, and discontiguous ipsilateral adrenal gland involvement is collected in distant metastasis, as

elements in anatomic staging. This information is also collected in this field as it may have an

independent effect on prognosis.

If surgical resection is done and tumor is “confined to kidney” and staging is based on size, then

there is no involvement of the adrenal gland

Note 3: Record ipsilateral adrenal gland involvement as documented in the pathology report.

Note 4: Do not use imaging findings to code this data item.

Note 5: Code 9 if surgical resection of the primary site is performed and there is no mention of

ipsilateral adrenal gland involvement.

Code Description

0 Ipsilateral adrenal gland involvement not present/not identified

1 Adrenal gland involvement by direct involvement (contiguous involvement)

2 Adrenal gland involvement by separate nodule (discontiguous involvement)

3 Combination of code 1-2

4 Ipsilateral adrenal gland involvement, unknown if direct involvement or separate nodule

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Ipsilateral adrenal gland not resected

Ipsilateral adrenal gland involvement not assessed or unknown if assessed

No surgical resection of primary site is performed

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00600: Kidney Parenchyma (2018+)

3925: Sarcomatoid Features

Item Length: 3

NAACCR Item #: 3925

XML Parent-NAACCR ID: Tumor-sarcomatoidFeatures

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00600: Kidney (2018+)

Description

Sarcomatoid features: present or absent and percentage refers to the observation of sheets and

fascicles of malignant spindle cells in a kidney tumor which can occur across all histologic subtypes. The

percentage of sarcomatoid component has been shown to correlate with cancer-specific mortality.

Rationale

Sarcomatoid features for Kidney is a Registry Data Collection Variable in AJCC. It was previously

collected as Kidney, CS SSF #4.

Definition

The presence of sarcomatoid or spindle cell features in a kidney tumor is a strong adverse prognostic

factor. There is a specific ICD-O morphology code for renal cell carcinoma, sarcomatoid or spindle cell

(8318/3), but this data item documents any sarcomatoid or spindle cell features in any renal cell cancer.

Note: This data item applies to carcinomas only; rare sarcomas of the kidney should not be

coded in this field

Code the percentage of sarcomatoid features documented anywhere in the pathology report

Coding guidelines

Record whether Sarcomatoid features are present or absent.

Code 000 when the pathology report states that there are no sarcomatoid features

Code 001-100 code exact percentage of sarcomatoid features appropriately [1% (001) to 100%

(100)]

Code R01-R05 when only range documented (specific percentage not available)

Code XX5 when the only information available about Sarcomatoid features is from a metastatic site

Code XX6 when sarcomatoid features present, percentage unknown

Code XX7 when histology is not renal cell carcinoma

Code XX9 when

o Not documented in medical record

o No surgical resection done

o Pathology report not available

o Sarcomatoid features not evaluated (not assessed)

o Unknown if Sarcomatoid Features evaluated (assessed)

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Additional Information

For further information, refer to the Kidney cancer protocol published by the College of

American Pathologists for the AJCC Staging System Kidney

Other names: spindle cell features

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of sarcomatoid features, the registrar could assume that they were not present

and code appropriately. For the SSDI, this assumption cannot be made. There must be a

statement that sarcomatoid features are not present to code 000.

Coding Instructions and Codes

Note 1: Physician statement of Sarcomatoid Features can be used to code this data item.

Note 2: Sarcomatoid morphology may be manifested by any renal cell carcinoma. The presence of

sarcomatoid component in a renal cell carcinoma may be prognostically important.

Note 3: Sarcomatoid features is mostly seen with renal cell carcinoma (all variants); however, if it’s seen

with other histologies, it can be coded.

Note 4: Record the presence or absence of sarcomatoid features as documented anywhere in the

pathology report.

Note 5: Code XX5 when the only information available about Sarcomatoid features is from a metastatic

site.

Note 6: Do not use imaging findings to code this data item.

Note 7: Code XX9 if surgical resection of the primary site is performed and there is no mention of

sarcomatoid features.

Code Description

000 Sarcomatoid features not present/not identified

001-100 Sarcomatoid features 1-100%

R01 Sarcomatoid features stated as less than 10%

R02 Sarcomatoid features stated as range 10%-30% present

R03 Sarcomatoid features stated as a range 31% to 50% present

R04

Sarcomatoid features stated as a range 51% to 80% present

R05

Sarcomatoid features stated as greater than 80%

XX5 Sarcomatoid features present from metastatic site only AND

Sarcomatoid features not present, or unknown if present, in primary site

XX6 Sarcomatoid features present, percentage unknown

XX7 Not applicable: Not a renal cell carcinoma morphology

XX8

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XX8 may result in an

edit error.)

XX9

Not documented in medical record

Sarcomatoid features not assessed or unknown if assessed

No surgical resection of primary site is performed

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00631: Urethra (2018+)

3926: Schema Discriminator 1: Urethra/Prostatic Urethra

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00631: Urethra (2018+)

00633: Urethra-Prostatic (2018+)

Definition

Urethra (male and female) and prostatic urethra have the same ICD-O topography code (C680).

However, for purposes of stage grouping AJCC 8

edition, they each have different definitions for T or

primary tumor extension. A schema discriminator is necessary to distinguish between these primary

sites so that the appropriate sub(chapter)/schema is used.

Coding Instructions and Codes

Note: A schema discriminator is used to discriminate between urethra (male and female) and prostatic

urethra. Code the site in which the tumor arose.

00631: Urethra (see code 1)

o Subsites include: Urethra, NOS; Urethral gland, Cowper gland

00633: Urethra-Prostatic Urethra (see code 2)

o Subsites include: Prostatic urethra, Prostatic utricle

Code Description Schema ID#/Description

1 Male penile urethra

Female urethra

Urethral gland

Cowper gland

Urethra, NOS

00631: Urethra

2 Males only

Prostatic urethra

Prostatic utricle

00633: Urethra-Prostatic

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00633: Urethra-Prostatic (2018+)

See 00631: Urethra (2018+)

3926: Schema Discriminator 1: Urethra/Prostatic Urethra

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OPHTHALMIC SITES

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00640: Skin Eyelid (2018+)

3909: Perineural Invasion

Item Length: 1

NAACCR Item #: 3909

XML Parent-NAACCR ID: Tumor-perineuralInvasion

NAACCR Alternate Name: None

Active years: 2018+

AJCC 8th Edition Chapter(s):

Chapter 15: Cutaneous Carcinoma of the Head and Neck (2018+)

Chapter 20: Colon and Rectum (2018+)

Chapter 64: Eyelid Carcinoma (2018+)

Chapter 69: Lacrimal Gland (2018+)

Description

Perineural Invasion, within or adjacent to the primary tumor, is a negative prognostic factor for

cutaneous squamous cell carcinomas of the head and neck and carcinomas of the colon and rectum,

eyelid and lacrimal gland.

Rationale

Perineural Invasion is a Registry Data Collection Variable in AJCC. It was previously collected as Colon

and Rectum CS SSF #8 and Lacrimal Gland CS SSF #4.

Definition

Perineural invasion is infiltration of nerves in the area of the lesion by tumor cells or spread of tumor

along the nerve pathway. The presence of perineural invasion has been shown in several studies to be

an indicator of poor patient prognosis. Where positive findings like perineural invasion are expected to

be included in pathology reports, negative results can be assumed if they are not specifically addressed.

Code whether perineural invasion is present based on the description in the pathology report.

Additional Information

Source documents: pathology report

Other names: PNI, neurotropism

Change from Collaborative Stage v2 (CSv2): In CSv2, if pathology report was available and there

was no mention of perineural invasion, the registrar could assume that it was negative and code

appropriately. Per the SSDI as of 2018, this assumption cannot be made. There must be a

statement that perineural invasion is not present/negative to assign “negative.” (Code 0)

Coding Instructions and Codes

Note 1: Physician statement of microscopically confirmed perineural invasion can be used to code this

data item when no other information is available.

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Note 2: Code the presence or absence of perineural invasion by the primary tumor as documented in

the pathology report.

Note 3: Information on presence of perineural invasion can be taken from either a biopsy or resection.

Absence of perineural invasion can only be taken from a surgical resection pathology report.

Note 4: Code 9 if surgical resection of the primary site is performed and there is no mention of

perineural invasion.

Code Description

Perineural invasion not identified/not present

Non-invasive neoplasm (behavior /2)

1 Perineural invasion identified/present

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Pathology report does not mention perineural invasion

Cannot be determined by the pathologist

Perineural invasion not assessed or unknown if assessed

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00660: Melanoma Conjunctiva (2018+)

See 00671: Melanoma Iris (2018+)

3888: Measured Thickness

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00671: Melanoma Iris (2018+)

3926: Schema Discriminator 1: Melanoma Ciliary Body/Melanoma Iris

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Definition

Iris and ciliary body have the same ICD-O topography code (C694). However, for purposes of stage

grouping AJCC 8

edition, they each have different definitions for T or primary tumor extension. A

schema discriminator is necessary to distinguish between these primary sites so that the appropriate

sub(chapter)/schema is used.

Coding Instructions and Codes

Note: A schema discriminator is used to discriminate between melanoma tumors with primary site code

C694: Ciliary Body/Iris. Code the site in which the tumor arose.

00672: Melanoma Choroid and Ciliary Body (see code 1)

o Subsites include: Ciliary body, crystalline lens, sclera, uveal tract, intraocular, eyeball

00671: Melanoma Iris (see code 2)

o Subsite includes: Iris

Code Description Schema ID#/Description

1 Ciliary Body

Crystalline lens

Sclera

Uveal tract

Intraocular

Eyeball

00672: Melanoma Choroid and Ciliary Body

2 Iris 00671: Iris

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00671: Melanoma Iris (2018+)

3821: Chromosome 3 Status

Item Length: 1

NAACCR Item #: 3821

XML Parent-NAACCR ID: Tumor-chromosome3Status

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Chromosome 3 Status refers to the partial or total loss of Chromosome 3, which is a prognostic factor

for uveal melanoma.

Rationale

Chromosome 3 Status is a Registry Data Collection Variable in AJCC. This data item was previously

collected as Uveal Melanoma, CS SSF #5.

Definition

The loss of an entire copy of chromosome 3, which occurs in about half of patients, is the most

important indicator of poor prognosis for the uveal melanomas, particularly melanoma of the choroids

and ciliary body. A variety of sophisticated tests can be used to determine chromosome 3 status

Karyotyping

Fluorescence in situ hybridization

Comparative genomic hybridization

DNA polymorphism analysis (e.g., single nucleotide polymorphism, microsatellite)

Multiplex ligation probe amplification

Monosomy 3 means loss of chromosome 3. Determination of chromosome status may be

affected by prior irradiation

Coding guidelines

Code 0 when there is no loss of chromosome 3, or disomy 3

Code 1 when there is partial loss of chromosome 3

Code 2 when there is complete loss of chromosome 3, or monosomy 3

Code 3 when there is loss of chromosome 3, how much not known

Code 7 when test done, but test results not available

Code 9 when

o No documentation in the medical record

o Chromosome 3 not evaluated (assessed)

o Unknown if Chromosome 3 evaluated (assessed)

o Patients received radiation therapy prior to testing

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Additional Information

Source documents: pathology report, specialty/reference lab report, gene expression profile

report, other statement in medical record

For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

Other names: Monosomy 3, loss of chromosome 3, chromosome 3 loss of heterozygosity (LOH),

isodisomy 3 (rare)

Coding Instructions and Codes

Note 1: Physician statement of chromosome 3 status can be used to code this data item when no other

information is available.

Note 2: Monosomy 3, especially if combined with a frequently coexisting gain in chromosome 8q, is

independently associated with metastatic risk. Chromosome 3 and 8 statuses may be determined with

karyotyping or fluorescent in situ hybridization (FISH).

Note 3: See also 3822: Chromosome 8q Status.

Code Description

0 No loss of chromosome 3

1 Partial loss of chromosome 3

Complete loss of chromosome 3

3 Loss of chromosome 3, NOS

7 Test ordered, results not in chart

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Chromosome 3 status not assessed or unknown if assessed

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00671: Melanoma Iris (2018+)

3822: Chromosome 8q Status

Item Length: 1

NAACCR Item #: 3822

XML Parent-NAACCR ID: Tumor-chromosome8qStatus

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Chromosome 8q Status refers to gain in Chromosome 8q, which is a prognostic factor for uveal

melanoma.

Rationale

Chromosome 8q Status is a Registry Data Collection Variable in AJCC. This data item was previously

collected as Uveal Melanoma, CS SSF #7.

Definition

The loss of an entire copy of chromosome 8, which occurs in about half of patients, is the most

important indicator of poor prognosis for the uveal melanomas, particularly melanoma of the choroids

and ciliary body. A variety of sophisticated tests can be used to determine chromosome 8 status

Karyotyping;

Fluorescence in situ hybridization;

Comparative genomic hybridization

DNA polymorphism analysis (e.g., single nucleotide polymorphism, microsatellite);

Multiplex ligation probe amplification;

Monosomy 3 means loss of chromosome 3. Determination of chromosome status may be

affected by prior irradiation.

Coding guidelines

Code 0 when there is no gain in chromosome 8q

Code 1 when there is gain in chromosome 8q

Code 7 when test done, but results not available

Code 9 when

o No documentation in the medical record

o Chromosome 8q not evaluated (assessed)

o Unknown if Chromosome 8q evaluated (assessed)

o Patients received radiation therapy prior to testing

Additional Information

Source documents: pathology report, specialty/reference lab report, gene expression profile

report, other statement in medical record

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For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

Other names: 8q duplication, 8q trisomy, duplication 8q, partial trisomy 8q, trisomy 8q

Coding Instructions and Codes

Note 1: Physician statement of chromosome 8q status can be used to code this data item when no other

information is available.

Note 2: Monosomy 3, especially if combined with a frequently coexisting gain in chromosome 8q, is

independently associated with metastatic risk. Chromosome 3 and 8 statuses may be determined with

karyotyping or fluorescent in situ hybridization.

Note 3: See also 3821: Chromosome 3 Status.

Code Description

0 No gain in chromosome 8q

Gain in chromosome 8q

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

Not

documented in medical record

Chromosome 8q status not assessed or unknown if assessed

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00671: Melanoma Iris (2018+)

3834: Extravascular Matrix Patterns

Item Length: 1

NAACCR Item #: 3834

XML Parent-NAACCR ID: Tumor-extravascularMatrixPatterns

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Extravascular Matrix Patterns, the presence of loops and networks in extracellular matrix patterns, is a

prognostic factor for uveal melanoma.

Rationale

Extravascular Matrix Patterns is a Registry Data Collection Variable in AJCC 8. This data item was

previously collected as Uveal Melanoma, CS SSF #11 and CS SSF #12. These two data items were

combined into one data for cases diagnosed 1/1/2018+.

Definition

The presence of extravascular matrix patterns is an indicator for shorter survival. There are two

different types of patterns: loops only, or loops forming networks. The identification of the complex

monocirculatory patterns (i.e., loops, networks, arcs with branching, parallel with cross-linking or a

combination of these patterns) are done using confocal indocyanine green angiography. The patterns

are assessed with light microscopy under a dark green filter after staining with periodic-acid Schiff

without counterstain. This determines the presence or absence of each matrix pattern, which appear

deep purple against a pink background.

Coding guidelines

Code 0 when pathology report states loops, and networks not found

Code 1 when pathology reports states networks and/or loops present

Code 9 when the ER is

o Pathology report available and there is no mention of extravascular matrix patterns

(loops or networks)

o Extravascular matrix patterns not assessed or unknown if assessed

Additional Information

Source documents: pathology report, confocal indocyanine green angiography report, clinician

comment

For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

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Coding instructions and Codes

Note 1: Physician statement of extravascular matrix patterns can be used to code this data item when

no other information is available.

Note 2: The presence of certain types of extravascular matrix patterns is independently associated with

the risk of metastasis. This is documented conclusively for individual loops and for loops forming

networks consisting of at least three back-to-back loops. Absence of both loops and networks is

associated with the longer survival and presence of loops forming networks is associated with the

shortest survival time.

Code Description

0 Extravascular matrix patterns not present/not identified

1 Extravascular matrix patterns present/identified

8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

9 Not documented in medical record

Extravascular Matrix Patterns not assessed or unknown if assessed

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00671: Melanoma Iris (2018+)

3887: Measured Basal Diameter

Item Length: 4

NAACCR Item #: 3887

XML Parent-NAACCR ID: Tumor-measuredBasalDiameter

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Measured Basal Diameter, the largest basal diameter of a uveal melanoma, is a prognostic indicator for

this tumor.

Rationale

Measured Basal Diameter is listed as a Registry Data Collection Variable in AJCC. It was previously

collected as Uveal Melanoma, CS SSF #2.

Definition

The basal diameter is the width (horizontal measurement) of the melanoma at its base (in contact with

sclera). This is not the same as the depth of invasion (see NAACCR Data Item #3888-Measured

Thickness). Clinical research has shown that as a uveal tumor becomes larger, the risk of hematogenous

metastases and death increases. In addition, knowing the size of the melanoma is important for

treatment planning.

Per the CAP guidelines for Uveal Melanoma, “in clinical practice, the largest tumor basal diameter may

be estimated in optic disc diameters (dd, average: 1 dd = 1.5 mm). Techniques such as ultrasonography

and fundus photography are used to provide more accurate measurement. When histopathological

measurements are recorded after fixation, tumor diameter and thickness may be underestimated

because of tissue shrinkage.”

Additional Information

Source documents: high-frequency ultrasonography (ultrasound biomicroscopy) report,

pathology report, wide-angle fundus camera measurement, clinician report or other

documentation in medical record

For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

Other names: largest tumor diameter (LTD), tumor basal size; do not code tumor basal area

(measured in square millimeters)

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Coding Instructions and Codes

Note 1: Physician statement of measured basal diameter (not the same as tumor size) can be used to

code this data item when no other information is available.

Note 2: Code Measured Basal Diameter of tumor not size. Record actual measurement in millimeters

(mm) to nearest tenth from clinical documentation, or from a pathology report if surgery performed.

Code

Description

0.0 No mass/tumor found

0.1-99.9 0.1 – 99.9 millimeters (mm)

(Exact measurement to nearest tenth of mm)

XX.0 100 millimeters (mm) or larger

XX.1 Described as "less than 3 mm"

XX.2 Described as “at least” 3 mm

XX.3 Described as “at least” 6 mm

XX.4 Described as “at least” 9 mm

XX.5

Described as “at

least” 12 mm

XX.6 Described as “at least” 15 mm

XX.7

Described as “at least” 18 mm

XX.8 Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XX.8 may result in an

edit error.)

XX.9 Not documented in medical record

Cannot be determined by pathologist

Measured Basal Diameter not assessed or unknown if assessed

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00671: Melanoma Iris (2018+)

3888: Measured Thickness

Item Length: 4

NAACCR Item #: 3888

XML Parent-NAACCR ID: Tumor-measuredThickness

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Measured Thickness, or height, the thickness of a uveal melanoma, is a prognostic indicator for this

tumor.

Rationale

Measured Thickness is listed as a Registry Data Collection Variable in AJCC. It was previously collected as

Uveal Melanoma, CS SSF #3.

Definition

This data items measures tumor thickness, height or depth (vertical dimension), rather than size (lateral

dimension) of basal diameter (horizontal dimension). (For basal diameter, see NAACCR Data Item #3887-

Measured Basal Diameter).

The depth of invasion or tumor thickness measurement for melanomas of the choroid, ciliary body, and

iris is collected in tenths of millimeters as stated in the pathology report for the resected specimen. (This

is similar to, but not the same as, Breslow depth of invasion, which is measured in hundredths of

millimeters.) Code a measurement specifically labeled as “thickness” “height” or “depth” in the

pathology report. In the absence of this label, a measurement described as taken from the cut surface of

the specimen can be coded. And in the absence of either of these labels, the third dimension in a

statement of tumor size (length x width x depth) can be used by the registrar to code this field.

Per the CAP guidelines for Uveal Melanoma, “in clinical practice, tumor thickness may be estimated in

diopters (average: 2.5 diopters = 1 mm). Techniques such as ultrasonography and fundus photography

are used to provide more accurate measurement. When histopathological measurements are recorded

after fixation, tumor diameter and thickness may be underestimated because of tissue shrinkage.”

Additional Information

Source documents: high-frequency ultrasonography (ultrasound biomicroscopy) report,

pathology report, wide-angle fundus camera measurement, clinician report or other

documentation in medical record

For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

Other names: maximum tumor thickness, depth of invasion; perpendicular tumor diameter

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(PTD); tumor height

Coding Instructions and Codes

Note 1: Physician statement of measured thickness, or height, can be used to code this data item when

no other information is available.

Note 2: Code Measured Thickness, or height, of tumor, not size. Record actual measurement in

millimeters (mm) from clinical documentation, or from a pathology report if surgery performed.

Code

Description

0.0 No mass/tumor found

0.1-99.9 0.1 – 99.9 millimeters (mm)

(Exact measurement to nearest tenth of mm)

XX.0 100 millimeters (mm) or larger

XX.1 Described as "less than 3 mm"

XX.2 Described as “at least” 3 mm

XX.3 Described as “at least” 6 mm

XX.4 Described as “at least” 9 mm

XX.5 Described as “at least” 12 mm

XX.6

Described as “greater than” 15 mm

XX.8

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XX.8 may result in an

edit error.)

XX.9 Not documented in medical record

Cannot be determined

Measured Thickness not assessed or unknown if assessed

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00671: Melanoma Iris (2018+)

3891: Microvascular Density

Item Length: 2

NAACCR Item #: 3891

XML Parent-NAACCR ID: Tumor-microvascularDensity

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Microvascular Density, a quantitative measure of tumor vascularity, is a prognostic factor for uveal

melanoma.

Rationale

Microvascular Density, is a Registry Data Collection Variable in AJCC. This data item was previously

collected as Uveal Melanoma, CS SSF #13.

Definition

A high density of microvessels, identified immunohistochemically using antibodies for vascular

endothelial cells (such as Factor VIII-related antigen, CD34 epitope, etc.), has prognostic significance in a

melanoma of the uvea. Higher counts have more unfavorable outcome. To obtain microvascular density,

the pathologist, using a microscope with an eyepiece graticule (grid) of approximately 0.3 square mm

and X200 magnification, counts microvessels from the most highly vascularized areas (“hot spots”) of

the tumor, identified by scanning the entire immunostained tumor at lower magnification. Any

immunolabeled element, clearly separate from an adjacent one and either totally inside the graticule or

touching its top or left border, is counted as a microvessel. In several studies, the range of microvascular

density was from 5 to 121 vessels, although this will vary depending on the type of immunostaining and

area of graticule used.

Code the microvascular density (number of microvessels) in whole numbers as stated in the pathology

report in the code range 001 (1 vessel per 0.3 square millimeters) to 500 (500 vessels per 0.3 square

millimeters).

Additional Information

Source documents: pathology report

For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

Coding Instructions and Codes

Note 1: Physician statement of microvascular density (MVD) can be used to code this data item when no

other information is available.

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Note 2: MVD is independently associated with metastatic risk. The number of immunopositive elements

is labeled with a marker for vascular endothelial cells (e.g., CD34 epitope, CD31 epitope, factor VIII-

related antigen) and counted from area of densest vascularization (typical field area, 0.3 mm2 squared).

Higher counts are associated with shorter survival.

Note 3: Record the results as expressed on the laboratory test. Record the information based on

quartiles for laboratory standards if this is the only expression of results.

Code Description

00 No vessels involved

01-99 01-99 vessels per 0.3 square millimeter (mm2)

X1 Greater than or equal to 100 vessels per 0.3 square millimeter (mm2)

X2 Lowest quartile for laboratory

X3 Second quartile for laboratory

X4 Third quartile for laboratory

X5 Highest quartile for laboratory

X7 Test ordered, results not in chart

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code 8 may result in an edit

error.)

Not documented in medical record

Microvascular Density (MVD) not assessed or unknown if assessed

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00671: Melanoma Iris (2018+)

3892: Mitotic Count Uveal Melanoma

Item Length: 4

NAACCR Item #: 3892

XML Parent-NAACCR ID: Tumor-mitoticCountUvealMelanoma

NAACCR Alternate Name: Mitotic None

Active years: 2018+

Schema(s):

00671: Melanoma Iris (2018+)

00672: Melanoma Choroid and Ciliary Body (2018+)

Description

Mitotic Count Uveal Melanoma, the number of mitoses per 40 high-power fields (HPF) based on

pathological evaluation, is a prognostic factor for uveal melanoma.

Rationale

Mitotic Count Uveal Melanoma is listed as a Registry Data Collection Variable in AJCC. It was previously

collected as Uveal Melanoma, CS SSF #9.

Definition

Mitotic count is collected for several different types of cancers. For melanomas of the choroids, ciliary

body and iris, the standard measurement is the total number of mitoses per 40 high power fields (HPF at

40 times magnification) per 0.152 square millimeters.

Additional Instructions

Source documents: pathology report

For further information, refer to the Uveal Melanoma cancer protocol published by the College

of American Pathologists for the AJCC Staging System Uveal Melanoma

Coding Instructions and Codes

Note 1: Physician statement of mitotic count for a uveal melanoma can be used to code this data item

when no other information is available.

Note 2: The mitotic count, the number of mitoses per 40 high-power fields (HPF), reflects the potential

aggressiveness or prognosis of uveal melanomas. This data item presumes the denominator of 40 HPF,

so just the numerator (the mitotic count) is coded here.

For other schemas in which mitotic count is collected, the denominator may vary.

Note 3: An HPF usually has a magnification objective of 40 (a 40x field). As described in the AJCC

chapter on uveal melanomas, the typical field area is 0.152 square millimeters (mm2).

Note 4: Record mitotic count to the nearest tenth as documented in the pathology report.

For example, a mitotic count of 6/40 HPF would be coded 6.0.

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Code Description

0.0 0 mitoses per 40 high-power fields (HPF)

Mitoses absent, no mitoses present, no mitotic activity

0.1-99.9 0.1-99.9 mitosis per 40 HPF

XX.1 100 or more mitoses per 40 HPF

XX.2 Stated as low mitotic count or rate with no specific number

XX.3 Stated as high mitotic count or rate with no specific number

XX.4 Mitotic count described with denominator other than 40 HPF

XX.7

Test

ordered

, results not in chart

XX.8

Not applicable: Information not collected for this case

(If this information is required by your standard setter, use of code XX.8 may result in an

edit error.)

XX.9 Not documented in medical record

Mitotic Count Uveal Melanoma not assessed or unknown if assessed

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00672: Melanoma Choiroid and Ciliary Body (2018+)

See 00671: Melanoma Iris

3926: Schema Discriminator 1: Melanoma Ciliary Body/Melanoma Iris

3821: Chromosome 3 Status

3822: Chromosome 8q Status

3834: Extravascular Matrix Patterns

3887: Measured Basal Diameter

3888: Measured Thickness

3891: Microvascular Density

3892: Mitotic Count Uveal Melanoma

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00680: Retinoblastoma (2018+)

3856: Heritable Trait

Item Length: 1

NAACCR Item #: 3856

XML Parent-NAACCR ID: Tumor-heritableTrait

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00680: Retinoblastoma (2018+)

Description

Heritable trait pertains to evidence that a tumor is associated with a heritable mutation. In

retinoblastoma, the heritable trait is a germline mutation in the RB1 gene, which is associated with

bilateral disease, family history of retinoblastoma, presence of concomitant CNS midline embryonic

tumor (commonly in pineal region), or retinoblastoma with an intracranial primitive neuroectodermal

tumor (i.e., trilateral retinoblastoma). Children with any of these features may be assigned the H1 status

without molecular testing. High quality molecular testing for RB1 mutation is required to determine the

presence or absence of RB1 mutation for children without clinical features of a heritable mutation.

Rationale

Heritable trait is required for prognostic stage grouping in AJCC 8

edition, Chapter 68 Retinoblastoma.

It is a new data item for cases diagnosed 1/1/2018+.

Definition

Heritable disease (trait) is defined by the presence of a germline mutation of the RB1 gene. This

germline mutation may have been inherited from an affected progenitor (25% of cases) or may have

occurred in a germ cell before conception or in utero during early embryogenesis in patients with

sporadic disease (75% of cases). The presence of positive family history or bilateral or multifocal disease

is suggestive of heritable disease.

Heritable retinoblastoma may manifest as unilateral or bilateral disease. The penetrance of the RB1

mutation (laterality, age at diagnosis, and number of tumors) is probably dependent on concurrent

genetic modifiers such as MDM2 and MDM4 polymorphisms. All children with bilateral disease and

approximately 15% of patients with unilateral disease are presumed to have the heritable form, even

though only 25% have an affected parent.

In heritable retinoblastoma, tumors tend to be diagnosed at a younger age than in the nonheritable

form of the disease. Unilateral retinoblastoma in children younger than 1 year raises concern for

heritable disease, whereas older children with a unilateral tumor are more likely to have the

nonheritable form of the disease.

Children with a germline RB1 mutation may continue to develop new tumors for a few years after

diagnosis and treatment; for this reason, they need to be examined frequently. It is common practice for

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examinations to occur every 2 to 4 months for at least 28 months. The interval between exams is based

on the stability of the disease and age of the child (i.e., less frequent visits as the child ages).

Patients with heritable retinoblastoma are also at a greater risk for subsequent neoplasms.

Heritable trait is required for prognostic stage grouping in the AJCC Staging System Retinoblastoma. It is

a new data item for cases diagnosed 1/1/2018+.

Additional Information

Source documents: lab reports (blood), pathology report

Coding Instructions and Codes

Note 1: Physician statement of retinoblastoma heritable trait can be used to code this data item.

Note 2: Code Heritable trait (H) based on the criteria listed in Chapter 68 Retinoblastoma “Definition of

Heritable Trait (H).”

Note 3: Code 0 (H0) if clinical features do not exist or laboratory germline RB1 test is negative or there is

no clinical evidence of mutation. Results may be from blood or tissue testing.

Note 4: Code 0 (H0) if residual (false negative) risk for a mutation is less than 1% or at population risk

(0.007%) in a laboratory with demonstrated sensitivity greater than 97%.

Note 5: Code 1 (H1) may be assigned based on positive molecular testing for germline RB1 gene.

Note 6: Code 1 (H1) may be assigned based on clinical evidence of any of the following features even

without molecular testing (in particular for children). When discrete clinical evidence of heritable trait is

not present, high-quality molecular evidence is mandatory before designating a child as H1 positive.

Bilateral disease

Family history of retinoblastoma

Presence of concomitant CNS midline embryonic tumor (commonly in pineal region)

Retinoblastoma with an intracranial primitive neuroectodermal tumor (i.e., trilateral

retinoblastoma)

Note 7: Variants of unknown significance should be categorized as 9 (HX).

Code Description

0 H0: Normal RB1 alleles

No clinical evidence of mutation

1 H1: RB1 gene mutation OR

Clinical evidence of mutation

7 Test ordered, results not in chart

9 HX: Not documented in medical record

Test not done, or unknown if done

Insufficient evidence of a constitutional RB1 gene mutation

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00690: Lacrimal Gland (2018+)

See 00640: Skin Eyelid (2018+)

3909: Perineural Invasion

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00690: Lacrimal Gland (2018+)

3926: Schema Discriminator 1: Lacrimal Gland/Sac

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00690: Lacrimal Gland (2018+)

00698: Lacrimal Duct (2018+)

Definition

The lacrimal (also spelled lachrymal) gland is the only epithelial structure normally present within the

orbit. Its composition is the same as epithelial salivary glands and AJCC TNM staging parallels that of the

major salivary gland classification

Lacrimal gland and lacrimal sac have the same ICD-O topography code (C695). However, for purposes of

the AJCC Staging System stage grouping, lacrimal gland is AJCC staged while lacrimal sac is not (Summary

Stage only). A schema discriminator is necessary to distinguish between these primary sites so that the

appropriate system/schema is used.

Coding Instructions and Codes

Note 1: A schema discriminator is used to discriminate between lacrimal gland and lacrimal sac tumors

with primary site code C695: Lacrimal Gland. Code the site in which the tumor arose.

Note 2: If the histology is transitional cell carcinoma (8120/3, 8130/3), assign code 2.

00690: Lacrimal Gland (see code 1)

o Subsites include: lacrimal gland

00698: Lacrimal Sac (see code 2)

o Subsites include: lacrimal sac, lacrimal duct (NOS), nasal lacrimal duct

Code Description Schema ID#/Description

1 Lacrimal gland 00690: Lacrimal Gland

Lacrimal sac

Lacrimal duct, NOS

Nasal lacrimal duct/sac

Nasolacrimal duct

00698: Lacrimal Sac

9 Lacrimal, NOS 00698: Lacrimal Sac

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00690: Lacrimal Gland (2018+)

3803: Adenoid Cystic Basaloid Pattern

Item Length: 5

NAACCR Item #: 3803

XML Parent-NAACCR ID: Tumor-adenoidCysticBasaloidPattern

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00690: Lacrimal Gland (2018+)

Description

Adenoid Cystic Basaloid Pattern, the presence of a basaloid pattern on pathological examination, is a

prognostic factor for adenoid cystic carcinoma of the lacrimal gland.

Rationale

Adenoid Cystic Basaloid Pattern is a Registry Data Collection Variable in AJCC 8. This data item was

previously collected as Lacrimal Gland, CS SSF #6.

Definition

Adenoid cystic carcinoma (ICD-O-3 morphology code 8200/3) is the most common malignant epithelial

tumor of the lacrimal gland. Adenoid cystic carcinoma is a tumor composed of modified myoepithelial

and ductal differentiated cells. A genetic alteration (i.e., fusion oncogene MYB-NFIB) is found in the

majority of adenoid cystic carcinomas There are three histologic patterns within the adenoid cystic

carcinoma group: cribriform, solid and tubular.

Coding guidelines

Code 0.0 when the pathology report states that basaloid or solid pattern is not present

Code 0.1-100.0 when the pathology report states the percent of basaloid or solid pattern that is

present

Code XXX.5 when basaloid or solid pattern present but percentage not known;

Code XXX.9 when

o Histopathologic pattern not documented in the medical record

o Histopathologic pattern not evaluated (assessed)

o Unknown if histopathologic pattern evaluated (assessed)

o When histologic type other than 8200 and there is no mention of basaloid pattern (see

Note 2 under coding instructions)

Additional Information

o Source documents: pathology report

o Other names: ACC, basaloid type adenoid cystic carcinoma

Coding Instructions and Codes

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Note 1: Physician statement of basaloid pattern can be used to code this data item when no other

information is available.

Note 2: This is most commonly found in Adenoid Cystic Carcinoma (8200/3) but can be present in other

histologies.

Code

Description

0.0-100.0 0.0 to 100.0 percent basaloid pattern

XXX.5 Basaloid pattern present, percentage not stated

XXX.8

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code XXX.8 will result in an edit

error.)

XXX.9 Not documented in medical record

Adenoid Cystic Basaloid Pattern not assessed or unknown if assessed

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00698: Lacrimal Sac (2018+)

See 00690: Lacrimal Gland

3926: Schema Discriminator 1: Lacrimal Gland/Sac

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CENTRAL NERVOUS SYSTEM

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00721: Brain (2018-2022)

3816: Brain Molecular Markers

Item Length: 2

NAACCR Item #: 3816

XML Parent-NAACCR ID: Tumor-brainMolecularMarkers

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00721: Brain (2018-2022)

09721: Brain (2023+)

00722: CNS Other (2018-2022)

09722: CNS Other (2023+)

Description

Multiple brain molecular markers have become standard pathology components necessary for

diagnosis. This data item captures clinically important brain cancer subtypes identified by molecular

markers that are not distinguishable by ICD-O-3 codes.

Rationale

Collection of these clinically important brain cancer subtypes has been recommended by CBTRUS.

Coding Instructions and Codes

Note 1: This data item applies only to ICD-O-3 histology codes: 9400/3, 9401/3, 9440/3, 9450/3,

9451/3, 9471/3 and 9478/3. If a microscopically confirmed histology is not included in this list, assign,

code 85.

If your case is not microscopically confirmed, code 99

Note 2: Physician statement of histologic subtype can be used to code this data item.

Note 3: Only one code is applicable for each tumor.

IDH mutation status distinguishes between clinically important subtypes within ICD-O-3 9400/3,

Diffuse astrocytoma and 9401/3, Anaplastic astrocytoma.

IDH mutant and 1p/19q co-deletion distinguishes between clinically important subtypes within

ICD-O-3 code 9450/3, Oligodendroglioma and 9451/3, Anaplastic Oligodendroglioma.

IDH-wildtype distinguishes clinically important subtypes within ICD-O-3 9400/3, Diffuse

astrocytoma, 9401/3, Anaplastic astrocytoma and 9440/3, Glioblastoma, Epithelioid

glioblastoma and Glioblastoma, NOS (note that the new ICD-O-3 code 9445/3 applies to

Glioblastoma, IDH-mutant; information regarding this subtype is not collected using this data

item).

SHH-activation and TP53-wildtype distinguishes between clinically important subtypes within

ICD-O-3 histology code 9471/3, Medulloblastoma.

C19MC alteration status distinguishes a clinically important highly aggressive subtype within

ICD-O-3 9478/3, Embryonal tumor with multilayered rosettes.

Examples:

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1. Biopsy of brain tumor, microscopic confirmation diagnosis: Diffuse Astrocytoma (9400/3). Additional

testing done, and IDH-mutant is identified. Code 01. Biopsy of brain tumor, microscopic

confirmation diagnosis: Anaplastic astrocytoma (9401/3). No further testing or results unknown.

Code 99.

2. MRI of brain tumor, clinical diagnosis: glioblastoma. No further workup. Code 99.

3. Biopsy of brain tumor, microscopic confirmation diagnosis: Mixed glioma (9382/3). Code 85.

Code

Description

01 Diffuse astrocytoma, IDH-mutant (9400/3)

02 Diffuse astrocytoma, IDH-wildtype (9400/3)

03 Anaplastic astrocytoma, IDH-mutant (9401/3)

04 Anaplastic astrocytoma, IDH-wildtype (9401/3)

05 Glioblastoma, IDH-wildtype (9440/3)

06 Oligodendroglioma, IDH-mutant and 1 p/19q co-deleted (9450/3)

07 Anaplastic oligodendroglioma, IDH-mutant and 1p/19q co-deleted (9451/3)

08 Medulloblastoma, SHH-activated and TP53-wildtype (9471/3)

09 Embryonal tumor with multilayered rosettes, C19MC-altered (9478/3)

85 Not applicable: Histology not 9400/3, 9401/3, 9440/3, 9450/3, 9451/3,

9471/3, 9478/3

86 Benign or borderline tumor

87 Test ordered, results not in chart

88 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 88 will result in an

edit error.)

99 Not documented in medical record

No microscopic confirmation

Brain molecular markers not assessed or unknown if assessed

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3801, 3802: Loss of Heterozygosity: Chromosome 1p and Chromosome 19q (CNS)

Definition

These two genetic tests are frequently done at the same time and reported together. Loss of

heterozygosity (LOH) in a chromosome means that genetic material normally found in a specific area of

a chromosome is missing. In other words, this is damage to the chromosome that results in failure of

tumor suppression, which in turn may cause the development or progression of a malignancy. For 1p

LOH, the specific chromosomal defect is on the short arm (p) of chromosome 1. For 19q LOH, the

specific chromosomal defect is on the long arm (q) of chromosome 19.

Normal cells have two complete copies of each chromosome, a state called heterozygosity. The loss of

this section of the chromosome is associated with improved outcome. It can be used to aid diagnosis

and to make treatment decisions because sensitivity to chemotherapy agents, such as lomustine,

procarbazine, and vincristine, is increased with either 1p or 19q LOH. Special molecular diagnostic

(polymerase chain reaction or gene amplification) tests look for missing genetic material. LOH for

chromosome 1p and 19q is tested primarily for oligodendroglioma, anaplastic oligodendroglioma,

oligoastrocytoma, and anaplastic oligoastrocytoma. It is infrequently tested for other gliomas, such as

glioblastoma multiforme.

Coding guidelines

Code 0 when the 1p/19q is not identified/not present

Code 1 when the 1p/19q is present

Code 7 when the 1p/19q test was ordered but the results are not in the medical record

Code 9 when

o No documentation in the medical record

o 1p/19q test not done (not assessed)

o Unknown if 1p/19q test was performed (unknown if assessed)

Additional Information

Other names allelic loss, gene deletion, 1p/19q fragment analysis

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3801: Chromosome 1p: Loss of Heterozygosity (LOH)

Item Length: 1

NAACCR Item #: 3801

XML Parent-NAACCR ID: Tumor-chromosome1pLossHeterozygosity

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00721: Brain (2018-2022)

09721: Brain (2023+)

00722: CNS Other (2018-2022)

09722: CNS Other (2023+)

Description

Chromosome 1p: Loss of Heterozygosity (LOH) refers to the loss of genetic material normally found on

the short arm of one of the patient's two copies of chromosome 1. Codeletion of Chromosome 1p and

19q is a diagnostic, prognostic and predictive marker for gliomas and is strongly associated with the

oligodendroglioma phenotype.

Rationale

Chromosome 1p: Loss of Heterozygosity (LOH) is a Registry Data Collection Variable in AJCC. It was

previously collected as Brain, CS SSF #5.

See 3801, 3802: Loss of Heterozygosity: Chromosome 1p and Chromosome 19q (CNS) for additional

information.

Coding Instructions and Codes

Note 1: Physician statement of Chromosome 1p deletion/LOH can be used to code this data item.

Note 2: This is a special molecular diagnostic test performed on tumor tissue to identify loss of genetic

material normally found on the short arm of one of the patient's two copies of chromosome 1. A normal

cell will contain two complete copies of each chromosome, one from each parent, and this normal state

is termed heterozygous. Loss of heterozygosity (LOH) is an abnormal state reflecting loss of the whole

arm of chromosome 1p following a chromosomal translocation event.

Note 3: Other terms for LOH include whole arm loss, gene deletion and allelic loss.

Note 4: Below is a list of histologies/terms for which the Chromosome 1p test is commonly done. If the

test was done, record the results, regardless of the histology.

9382/3: Oligoastrocytoma (anaplastic, or NOS)

9400/3: Diffuse astrocytoma (IDH mutant, IDH wild type, or NOS)

9401/3: Anaplastic astrocytoma (IDH mutant, IDH wild type, or NOS)

9411/3: Gemistocytic astrocytoma, IDH mutant

9424/3: Anaplastic pleomorphic xanthoastrocytoma

9430/3: Astroblastoma

9440/3: Glioblastoma (epithelioid, IDH wild type, or NOS)

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9441/3: Giant cell glioblastoma

9442/3: Gliosarcoma

9445/3: Glioblastoma, IDH mutant

9450/3: Oligodendroglioma (IDH mutant and 1p/19q codeleted, or NOS)

9451/3: Anaplastic oligodendroglioma (IDH mutant and 1p/19q codeleted, or NOS)

9505/3: Anaplastic ganglioglioma

9530/3: Anaplastic (malignant) meningioma

Note 5: If the histology is not listed among those for which the Chromosome 1p test is commonly done,

and the test result is not readily available, assume it was not done and code 9 for unknown.

Note 6: For brain tumors, tests for LOH of chromosomes 1p and 19q may be performed at the same

time and reported on a single report. See also 3802: Chromosome 19q: Loss of Heterozygosity (LOH).

Code Description

0 Chromosome 1p deletion/LOH not identified/not present

1 Chromosome 1p deletion/LOH identified/present

6 Benign or borderline tumor

7 Test ordered, results not in chart

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Cannot be determined by the pathologist

Chromosome 1p deletion/LOH not assessed or unknown if assessed

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3802: Chromosome 19q: Loss of Heterozygosity (LOH)

Item Length: 1

NAACCR Item #: 3802

XML Parent-NAACCR ID: Tumor-chromosome19qLossHeterozygosity

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00721: Brain

00722: CNS Other

Description

Chromosome 19q: Loss of Heterozygosity (LOH) refers to the loss of genetic material normally found on

the long arm of one of the patient's two copies of chromosome 19. Codeletion of Chromosome 1p and

19q is a diagnostic, prognostic and predictive marker for gliomas and is strongly associated with the

oligodendroglioma phenotype.

Rationale

Chromosome 19q: Loss of Heterozygosity (LOH) is a Registry Data Collection Variable in AJCC. It was

previously collected as Brain, CS SSF #6.

See 3801, 3802: Loss of Heterozygosity: Chromosome 1p and Chromosome 19q (CNS) for additional

information.

Coding Instructions and Codes

Note 1: Physician statement of Chromosome 19q deletion/LOH can be used to code this data item.

Note 2: This is a special molecular diagnostic test performed on tumor tissue to identify loss of genetic

material normally found on the long arm of one of the patient's two copies of chromosome 19. A normal

cell will contain two complete copies of each chromosome, one from each parent, and this normal state

is termed heterozygous. Loss of heterozygosity (LOH) is an abnormal state reflecting loss of the whole

arm of chromosome 19q following a chromosomal translocation event.

Note 3: Other terms for LOH include whole arm loss, deletion and allelic loss.

Note 4: Below is a list of histologies/terms for which the Chromosome 19q test is commonly done. If the

test was done, record the results, regardless of the histology.

9382/3: Oligoastrocytoma (anaplastic, or NOS)

9400/3: Diffuse astrocytoma (IDH mutant, IDH wild type, or NOS)

9401/3: Anaplastic astrocytoma (IDH mutant, IDH wild type, or NOS)

9411/3: Gemistocytic astrocytoma, IDH mutant

9424/3: Anaplastic pleomorphic xanthoastrocytoma

9430/3: Astroblastoma

9440/3: Glioblastoma (epithelioid, IDH wild type, or NOS)

9441/3: Giant cell glioblastoma

9442/3: Gliosarcoma

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9445/3: Glioblastoma, IDH mutant

9450/3: Oligodendroglioma (IDH mutant and 1p/19q codeleted, or NOS)

9451/3: Anaplastic oligodendroglioma (IDH mutant and 1p/19q codeleted, or NOS)

9505/3: Anaplastic ganglioglioma

9530/3: Anaplastic (malignant) meningioma

Note 5: If the histology is not listed among those for which the Chromosome 1p test is commonly done,

and the test result is not readily available, assume it was not done and code 9 for unknown.

Note 6: For brain tumors, tests for LOH of chromosomes 1p and 19q may be performed at the same

time and reported on a single report. See also 3801: Chromosome 1p: Loss of Heterozygosity (LOH).

Code Description

0 Chromosome 19q deletion/LOH not identified/not present

1 Chromosome 19q deletion/LOH present

6 Benign or borderline tumor

7 Test ordered, results not in chart

Not applicable:

Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Cannot be determined by the pathologist

Chromosome 19q: LOH not assessed or unknown if assessed

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00721: Brain (2018-2022)

3889: Methylation of O6-Methylguanine-Methyltransferase

Item Length: 1

NAACCR Item #: 3889

XML Parent-NAACCR ID: Tumor-methylationOfO6MGMT

NAACCR Alternate Name: Methylation of O6-Methylguanine-Methyltransferase (MGMT)

Active years: 2018+

Schema(s):

00721: Brain (2018)

09721: Brain (2023+)

00722: CNS Other

Description

O6-Methylguanine-Methyltransferase (MGMT) is an enzyme in cells that repairs DNA. Methylation of

the MGMT gene reduces production of the MGMT enzyme and the ability of tumor cells to repair

damage caused by chemotherapy. Methylation of MGMT is a prognostic and predictive factor for high

grade gliomas.

Rationale

Methylation of O6-Methylguanine-Methyltransferase (MGMT) is a Registry Data Collection Variable in

AJCC. It was previously collected as Brain, CS SSF #4.

Definition

O6-Methylguanine-Methyltransferase (MGMT) is an enzyme in cells that repairs DNA. DNA repair is

undesirable in tumors, because it may enable them to overcome the DNA damage done by

chemotherapy. With methylation, less MGMT enzyme is produced, which may lead to prolonged

survival compared to unmethylated MGMT

A patient with increased MGMT methylation is more likely to respond to alkylating agents such as

temozolomide (Temodar) and the nitrosoureas, some of the few drugs effective for brain tumors.

MGMT methylation is a special (not routine) molecular test done on tumor tissue. It is used primarily for

anaplastic oligodendroglioma, anaplastic astrocytoma and glioblastoma multiforme, but can also be

done for low grade malignant central nervous system tumors.

Coding guidelines

Code 0 when the MGMT is not identified/not present

Code 1 when the MGMT is low

Code 2 when the MGMT is high

Code 3 when the MGMT is mentioned, but not stated as low or high

Code 6 for a benign (/0) or borderline (/1) tumor

Code 7 when the MGMT test was ordered but the results are not in the medical record.

Code 9 when

o No information in the medical record about MGMT

o MGMT test not done (not assessed)

o Unknown if MGMT test was performed (unknown if assessed)

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Additional Information

Source documents: pathology report, specialty or reference laboratory report

Other names: MGMT promoter methylation, methylation status

Coding Instructions and Codes

Note 1: Physician statement of the methylation status of the MGMT, also termed MGMT promoter,

gene can be used to code this data item.

Note 2: O6-Methylguanine-Methyltransferase (MGMT) is an enzyme in cells that repairs DNA. DNA

repair is undesirable in tumors, because it may enable them to overcome the DNA damage done by

chemotherapy. With methylation, less MGMT enzyme is produced, which may lead to prolonged

survival compared to unmethylated MGMT.

Note 3: Below is a list of histologies/terms for which the MGMT test is commonly done. If the test was

done, record the results, regardless of the histology.

9382/3: Anaplastic oligoastrocytoma, NOS

9382/3: Oligoastrocytoma, NOS

9400/3: Diffuse astrocytoma (IDH mutant, IDH wild type, NOS)

9401/3: Anaplastic astrocytoma (IDH mutant, IDH wild type, NOS)

9411/3: Gemistocytic astrocytoma, IDH mutant

9424/3: Anaplastic pleomorphic xanthoastrocytoma

9440/3: Glioblastoma (epithelioid, IDH wild type, NOS)

9441/3: Giant cell glioblastoma

9442/3: Gliosarcoma

9445/3: Glioblastoma, IDH mutant

9450/3: Oligodendroglioma (IDH mutant and 1p/19q codeleted, NOS)

9451/3: Anaplastic oligodendroglioma (IDH mutant and 1p/19 codeleted, NOS)

9505/3: Anaplastic ganglioglioma

9530/3: Anaplastic (malignant)meningioma

Note 4: If the histology is not listed among those for which the MGMT test is commonly done, and the

test result is not readily available, assume it was not done and code 9 for unknown.

Code

Description

0 MGMT methylation absent/not present, unmethylated MGMT

1 MGMT methylation present, low level

Hypomethylated

Partial methylated

MGMT methylation present, high level

Hypermethylated

3 MGMT Methylation present, level unspecified

6 Benign or borderline tumor

7 Test ordered, results not in chart

Not applicable:

Information not

collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

Cannot be determined by the pathologist

MGMT not assessed or unknown if assessed

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09721: Brain (2023+)

See 00721: Brain (2018-2022)

3816: Brain Molecular Markers

3801: Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity (LOH)

3889: Methylation of O6-Methylguanine-Methyltransferase

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00722: CNS Other (2018-2022)

See 00721: Brain (2018-2022)

3816: Brain Molecular Markers

3801: Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity (LOH)

3889: Methylation of O6-Methylguanine-Methyltransferase

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09722: CNS Other (2023+)

See 00721: Brain (2018-2022)

3816: Brain Molecular Markers

3801: Chromosome 1p: Loss of Heterozygosity (LOH)

3802: Chromosome 19q: Loss of Heterozygosity (LOH)

3889: Methylation of O6-Methylguanine-Methyltransferase

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09724: Medulloblastoma (2023+)

See 00721, 00722, 09721, 09722: Brain and CNS Other

3816: Brain Molecular Markers (applicable for 2023+ only)

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ENDOCRINE SYSTEM

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00730: Thyroid (2018+)

3926: Schema Discriminator 1: Thyroid Gland/Thyroglossal Duct

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00730: Thyroid (2018+)

00740: Thyroid Medullary (2018+)

Definition

Thyroid, NOS and thyroglossal duct have the same ICD-O topography code (C739). However, for

purposes of the AJCC Staging Systems Thyroid and Thyroid Medullary stage groupings, Thyroid, NOS is

applicable for AJCC staging while thyroglossal duct is not (Summary Stage only). A schema discriminator

is necessary to distinguish between these primary sites so that the appropriate system/schema is used.

Coding Instructions and Codes

Note: A schema discriminator is used to discriminate between thyroid gland and thyroglossal duct

tumors with primary site code C739: Thyroid Gland. Code the site in which the tumor arose.

Thyroid gland (see code 1)

o Subsites include: Thyroid, NOS

Thyroglossal duct (see code 2)

Code Description

Thyroid gland

Thyroid, NOS

2 Thyroglossal duct cyst

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00740: Thyroid Medullary (2018+)

See 00730: Thyroid (2018+)

3926: Schema Discriminator 1: Thyroid Gland/Thyroglossal Duct

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HEMATOLOGIC MALIGNANCIES

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00790: Lymphoma (excluding CLL/SLL) (2018+)

3926: Schema Discriminator 1: Histology Discriminator for 9591/3

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00790: Lymphoma (2018+)

00830: HemeRetic (2018+)

Coding Notes and Instructions

Note: A schema discriminator is used to discriminate for histology 9591/3: Non-Hodgkin lymphoma to

determine which AJCC Stage Group table to use.

9591/3: Splenic B-cell lymphoma/leukemia, unclassifiable (see code 1)

Abstracted and staged as a leukemia

9591/3: Hairy cell leukemia variant (see code 2)

Abstracted and staged as a leukemia

9591/3: Splenic diffuse red pulp small B-cell lymphoma (see code 3)

Abstracted and staged as a lymphoma

9591/3: Non-Hodgkin lymphoma, NOS (see code 9)

Abstracted and staged as a lymphoma

Code Description Schema ID#/Description

1 Splenic B-cell lymphoma/leukemia, unclassifiable 00830: HemeRetic

Hairy cell leukemia variant

Prolymphocytic variant of hairy cell leukemia

00830: HemeRetic

Splenic diffuse red

pulp small B

cell lymphoma

Splenic marginal zone lymphoma, diffuse variant

Splenic red pulp lymphoma with numerous basophilic

villous lymphocytes

Splenic lymphoma with villous lymphocytes

00790: Lymphoma

(excluding CLL/SLL)

9 Non-Hodgkin lymphoma, NOS

Any other terminology describing NHL

00790: Lymphoma

(excluding CLL/SLL)

<Blank> Histology is NOT 9591, Discriminator is not necessary

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00790: Lymphoma (excluding CLL/SLL) (2018+)

3812: B Symptoms

Item Length: 1

NAACCR Item #: 3812

XML Parent-NAACCR ID: Tumor-bSymptoms

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00790: Lymphoma (excluding CLL/SLL) (2018+)

00795: Lymphoma-CLL/SLL (2018+)

Description

B symptoms refer to systemic symptoms of fever, night sweats, and weight loss which can be associated

with both Hodgkin lymphoma and some non-Hodgkin lymphomas. The presence of B symptoms is a

prognostic factor for some lymphomas.

Rationale

B symptoms is a Registry Data Collection Variable in AJCC. This data item was previously collected for

Lymphomas, SSF #2.

The stages of Hodgkin Lymphoma are classified as either A or B according to the absence or presence of

defined constitutional symptoms. The stage group suffix for a patient without these systemic symptoms

is “A,” meaning absence of symptoms or asymptomatic; for example, Stage IIA. The stage group suffix

for a patient with any of the symptoms listed below is “B,” such as Stage IIIB. The symptoms are

carefully defined

Fevers: Unexplained fever with temperature above 38 degrees centigrade or 101.5 degrees

Fahrenheit.

Night sweats: Drenching sweats (e.g. those that require change of bedclothes)

Weight loss: Unexplained weight loss of more than 10% of the usual body weight in the 6

months prior to diagnosis.

Other symptoms, such as chills, pruritic, alcohol-induced pain and fatigue, are not included in the A

or B designation but are recorded in the medical record, as the reappearance of these symptoms

may be a harbinger of recurrence. The designation A or B is not included in the revised staging of

NHL in AJCC8, although clinicians are encouraged to record the presence of these symptoms in the

medical record. The presence or absence of B symptoms may be collected in registries for both HL

and NHL.

Coding guidelines

Code 0 when there is no evidence of B symptoms present, per physician or physical exam

Code 1 when the physician states the patient has B symptoms

Code 9 when

o Not documented in the medical record

o B symptoms not evaluated (assessed)

o Unknown if B symptoms evaluated (assessed)

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Additional Information

Source documents: patient history, progress notes, consultant notes, other statements in

medical record

Other names: B symptoms; Fever: Palestine fever, hyperpyrexia, febrile response; sleep

hyperhidrosis, nocturnal hyperhydrosis

Note: This was previously required for staging under the Ann Arbor Staging Classification for

Lymphomas. The new Lugano Staging System does not require this for staging.

o Per AJCC 8

edition: “The designation A or B is not included in the revised staging of

NHL, although clinicians are encouraged to record the presence of these symptoms

in the medical record.”

o If your physicians no longer record the B symptoms because of this change, code 9

Change from Collaborative Stage v2 (CSv2): In CSv2, if there was no mention of B

symptoms, the registrar could assume that they were not present and code appropriately.

For the SSDI, this assumption cannot be made. There must be a statement that B symptoms

are not present to assign code 0.

Coding Instructions and Codes

Note 1: Physician statement of B symptoms can be used to code this data item when no other

information is available.

Note 2: Each stage should be classified as either A or B according to the absence or presence of defined

constitutional symptoms, such as

Fevers: Unexplained fever with temperature above 38 degrees C

Night sweats: Drenching sweats that require change of bedclothes

Weight loss: Unexplained weight loss of more than 10% of the usual body weight in the six

months prior to diagnosis

Note 3: Pruritus alone does not qualify for B classification, nor does alcohol intolerance, fatigue, or a

short, febrile illness associated with suspected infections.

Note 4: Code 9 if there is no mention of B symptoms.

Code Description

0 No B symptoms (asymptomatic)

Classified as “A” by physician when asymptomatic

1 Any B symptom(s)

Night sweats (drenching)

Unexplained fever (above 38 degrees C)

Unexplained weight loss (generally greater than 10% of body weight

in the six months before admission)

B symptoms, NOS

Classified as “B” by physician when symptomatic

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

B symptoms not assessed or unknown if assessed

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00790: Lymphoma (excluding CLL/SLL) (2018+)

3859: HIV Status

Item Length: 1

NAACCR Item #: 3859

XML Parent-NAACCR ID: Tumor-hivStatus

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00790: Lymphoma (excluding CLL/SLL) (2018+)

00795: Lymphoma-CLL/SLL (2018+)

Description

HIV status refers to infection with the Human Immunodeficiency Virus which causes Acquired Immune

Deficiency Syndrome (AIDS). AIDS is associated with increased risk of developing some lymphomas.

Rationale

HIV status can be collected by the surveillance community for neoplasms (e.g., Kaposi Sarcoma,

Lymphomas) that are closely related to HIV/AIDS. Prior to 2018, Lymphoma SSF#1 was used for HIV

Status.

Definition

Human immunodeficiency virus (HIV) is the causal agent for acquired immune deficiency syndrome

(AIDS). Certain types of cancer are associated with HIV and AIDS, including Hodgkin lymphoma, diffuse

large B-cell lymphoma, and primary central nervous system lymphoma. These diseases in patients with

HIV or AIDS have different clinical and pathological features from the same diseases when they occur in

the general population, such as more extranodal involvement. This data item documents whether the

patient has HIV infection or AIDS at the time of diagnosis.

Coding guidelines

Code whether the patient has HIV or AIDS, based on statements in the medical record. Do not assume

that the patient is negative for HIV or AIDS unless there is a statement to that effect; code 9 instead.

Code 0 when there is a statement in the record that

o HIV or AIDS is not present

o the patient has been tested and is negative for HIV or AIDS

o the patient has been tested and is not infected with HIV or AIDS

o the malignancy is not associated with human immunodeficiency virus (HIV) or

autoimmune deficiency syndrome (AIDS)

o an HIV or AIDS test has been done and is negative

Code 1 when there is a statement in the record that

o HIV or AIDS is present

o the patient is positive for HIV or AIDS

o the patient is infected with HIV or AIDS

o the patient has a history of HIV or AIDS

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o an HIV or AIDS test has been done and is positive

Code 9 when there is no mention of HIV or AIDS status in the medical record.

Additional Information

Source documents: clinical laboratory test, statement in medical record

Other names: HIV type 1, HIV type 2, ARC (AIDS related complex), PWA (person with AIDS),

PWARC (person with ARC); older terms for HIV type 1: HTLV-3, LAV

Coding Instructions and Codes

Note 1: Physician statement of HIV status can be used to code this data item when no other information

is available.

Note 2: Acquired Immune Deficiency Syndrome (AIDS) lymphomas are a late manifestation of Human

Immunodeficiency Virus (HIV) infection and have unique clinical and pathological features that differ

from lymphomas in the general population. They have a preponderance for extranodal involvement,

with central nervous system being the most common site.

Note 3: HIV includes types I and II. Older terminology includes Human T Lymphotropic Virus -3 (HTLV-3)

and Lymphadenopathy Associated Virus (LAV).

Note 4: Code 9 if there is no mention of HIV/AIDS in the medical record. Do not assume that the patient

is HIV negative.

Note 5: If patient has a history of HIV, assign code 1 even if HIV is not currently detectable.

Code Description

0 Not associated with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency

Syndrome (AIDS)

HIV negative

1 Associated with HIV/AIDS

HIV positive

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

HIV status not assessed or unknown if assessed

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00790: Lymphoma (excluding CLL/SLL) (2018+)

3896: NCCN International Prognostic Index (IPI)

Item Length: 2

NAACCR Item #: 3896

XML Parent-NAACCR ID: Tumor-nccnInternationalPrognosticIndex

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00790: Lymphoma (excluding CLL/SLL) (2018+)

00795: Lymphoma-CLL/SLL (2018+)

Description

The NCCN International Prognostic Index (IPI) (previously only “IPI”) is used to define risk groups for

specific lymphomas using a 0-8 score range, based on age, stage, number of extranodal sites of

involvement, patient’s performance status and LDH level.

Rationale

NCCN International Prognostic Index (IPI) is a Registry Data Collection Variable in AJCC. It was previously

collected for Lymphomas, SSF #3.

Definition

The NCCN International Prognostic Index (IPI) has been developed for lymphomas and predicts outcome

based on the following adverse factors:

Age greater than or equal to 60 years

Serum LDH greater than normal

Performance status 2-4

Stage III or IV

Extranodal involvement greater than 1 site

Additional Information

Source documents: patient history, progress notes, consultant notes, other statements in

medical record

Coding Instructions and Codes

Note 1: Physician statement of NCCN IPI must be used to code this data item. Do not calculate points or

assign risk. Only record points or risk if a physician has documented them. Use points over risk if both

are available.

Note 2: NCCN is applicable for non-Hodgkin lymphomas only.

If you have a score for Hodgkin lymphomas (IPS), do not record that information here. Code X9.

Note 3: A low, intermediate or high risk associated with Rai Stage is not recorded in this data item.

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Code Description

00-08 0-8 points

X1 Stated as low risk (0-1 point)

X2 Stated as low intermediate risk (2-3 points)

X3 Stated as intermediate risk (4-5 points)

X4 Stated as high risk (6-8 points)

Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code X8 will result in an edit error.)

Not documented in medical record

NCCN International Prognostic Index (IPI) status not assessed or unknown if assessed

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00795: Lymphoma-CLL/SLL (2018+)

See 00790: Lymphoma (excluding CLL/SLL)

3812: B Symptoms

3859: HIV Status

3896: NCCN International Prognostic Index (IPI)

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00795: Lymphoma-CLL/SLL (2018+)

Rai Classification

Definition

The Rai classification system is now used to stage chronic lymphocytic leukemia/small lymphocytic

lymphoma (CLL/SLL) (9823/3) when bone marrow and/or peripheral blood are involved using several

different criteria. The stages are based on the absence or presence of the following criteria

3885: Lymphocytosis

3804: Adenopathy

3907: Organomegaly

3811: Anemia

3933: Thrombocytopenia

Note: All of these data items are required for Staging for the AJCC Staging System Hodgkin and Non-

Hodgkin Lymphomas (9823/3 only) and EOD.

Rai stages

Stage 0 CLL is characterized by absolute lymphocytosis (>15,000/mm3) without adenopathy,

hepatosplenomegaly, anemia, or thrombocytopenia

Stage I CLL is characterized by absolute lymphocytosis with lymphadenopathy without

hepatosplenomegaly, anemia, or thrombocytopenia

Stage II CLL is characterized by absolute lymphocytosis with either hepatomegaly or

splenomegaly with or without lymphadenopathy

Stage III CLL is characterized by absolute lymphocytosis and anemia (hemoglobin <11 g/dL) with

or without lymphadenopathy, hepatomegaly, or splenomegaly

Stage IV CLL is characterized by absolute lymphocytosis and thrombocytopenia (<100,000/mm3)

with or without lymphadenopathy, hepatomegaly, splenomegaly, or anemia

Per confirmation from medical oncologists, Rai stage is only recorded for patients who have bone

marrow and/or peripheral blood involvement. Per the Hematopoietic Rules, primary site would be C421

(See Hematopoietic Manual, Module 3: Rules PH 5, 6). A new code has been added to the 5 SSDIs (code

5) to use when primary site is not C421.

A Derived Rai stage will be implemented in the 2022 updates. This new data item will take the

information from the 5 SSDIs (Lymphocytosis, Adenopathy, Organomegaly, Anemia, Thrombocytopenia),

where primary site is C421 and automatically derive the Rai stage

This table below can be used when the ONLY information available is the documented Rai stage from

the managing physician. (Note: The Rai stage cannot be found on a pathology report).

Rai

Stage

Definition Lymphocytosis Adenopathy Organomegaly Anemia Thrombocytopenia

Lymphocytosis only

Absolute Lymphocyte count > 5,000

cell/uL)

6 0 0 0 0

Lymphocytosis AND

Adenopathy

6 1 0 0 0

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Rai

Stage

Definition Lymphocytosis Adenopathy Organomegaly Anemia Thrombocytopenia

Lymphocytosis AND

Enlarged spleen and/or liver

(Organomegaly)

6 9 1 0 0

III

Lymphocytosis AND

Hemoglobin (Hgb) less than 11 g/dL

(Anemia)

6 9 9 6 0

Lymphocytosis AND

Platelet count < 100,000 /uL

(Thrombocytopenia)

6 9 9 9 6

For cases with diagnosis date of 2018+ and already abstracted with a primary site not equal to C421

(bone marrow), the SSDIs will be updated with a new code of 5, which is “Not applicable: Primary site is

not C421.” A Rai Stage of 88 will then be derived.

For CLL/SLL cases abstracted after the updates and primary site not equal to C421 (bone marrow), code

the SSDIs to 5.

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00795: Lymphoma-CLL/SLL (2018+)

3885: Lymphocytosis

Item Length: 1

NAACCR Item #: 3885

XML Parent-NAACCR ID: Tumor-lymphocytosis

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00795: Lymphoma-CLL/SLL (2018+)

Description

Lymphocytosis s defined by an excess of lymphocytes in the blood. In staging of Chronic Lymphocytic

Leukemia/Small Lymphocytic Leukemia (CLL/SLL), lymphocytosis is defined as an absolute lymphocyte

Rationale

Lymphocytosis is a prognostic factor required for staging of Chronic Lymphocytic Leukemia/Small

Lymphocytic Leukemia (CLL/SLL) in AJCC 8

edition, Chapter 79 Hodgkin and Non-Hodgkin Lymphomas.

It is a new data item for cases diagnosed 1/1/2018+.

See Rai Classification for additional information.

Coding Instructions and Codes

Note 1: For cases diagnosed 1/1/2018 and later, all cases of CLL and SLL will require both the Lugano

classification, which is captured in the AJCC stage group data item, and the five components of the

modified Rai staging system, which are captured in Site-Specific Data Items (adenopathy, anemia,

lymphocytosis, organomegaly, and thrombocytopenia)

The terms B-cell lymphocytic leukemia/chronic lymphocytic leukemia (CLL) and small lymphocytic

lymphoma (SLL) are different clinical presentations of the same disease, with both terms coded

9823. Traditionally the lymphoma diagnosis was staged with the Ann Arbor staging system and it is now

staged with the Lugano classification. In North America, CLL was staged with the Rai system.

Note 2: Rai stage is only applicable for CLL, in which the bone marrow and/or peripheral blood are

involved (primary site C421 for bone marrow, see Hematopoietic Manual, Module 3: PH 5, 6).

If primary site is not C421, code 5

Note 3: Lymphocytosis (lymphocyte number) is defined by an absolute lymphocyte count (ALC) > 5,000

Use the cut points listed in the table regardless of the lab’s reference range

For cases that document lymphocyte count in SI (Systeme Internationale) units as any of 10*9/L,

10^9/L, or 10E9/L, the cut point of 5,000 cells/µL is equivalent to (5 cells x 10*9/L), (5 cells X

10^9/L), or (5 cells x10E9/L)

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Note 4: Record this data item based on a blood test (CBC and differential) performed at diagnosis (pre-

treatment). In the absence of the lab test, a physician’s statement can be used.

Note 5: If there is no mention of lymphocytosis, or relevant lab results, code 9.

Note 6: The physician’s stated Rai stage always takes priority when there is conflicting information.

Code Description

0 Lymphocytosis not present

1 Lymphocytosis present

Absolute lymphocyte count > 5,000

5 Not applicable: Primary site is not C421

6 Lab value unknown, physician states lymphocytosis is present

Physician states Rai stage 0-IV

7 Test ordered, results not in chart

9 Not documented in medical record

Lymphocytosis not assessed or unknown if assessed

No Rai stage is documented in the record and there is no documentation of

lymphocytosis

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00795: Lymphoma-CLL/SLL (2018+)

3804: Adenopathy

Item Length: 1

NAACCR Item #: 3804

XML Parent-NAACCR ID: Tumor-adenopathy

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00795: Lymphoma-CLL/SLL (2018+)

Description

Adenopathy is defined as the presence of lymph nodes > 1.5 cm on physical examination (PE) and is part

of the staging criteria for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).

Rationale

Adenopathy is a prognostic factor required for staging of CLL/SLL in AJCC 8

edition, Chapter 79 Hodgkin

and Non-Hodgkin Lymphomas. It is a new data item for cases diagnosed 1/1/2018+.

See Rai Classification for additional information.

Coding Instructions and Codes

Note 1: For cases diagnosed 1/1/2018 and later, all cases of CLL and SLL will require both the Lugano

classification, which is captured in the AJCC stage group data item, and the five components of the

modified Rai staging system, which are captured in Site-Specific Data Items (adenopathy, anemia,

lymphocytosis, organomegaly, and thrombocytopenia)

The terms B-cell lymphocytic leukemia/chronic lymphocytic leukemia (CLL) and small lymphocytic

lymphoma (SLL) are different clinical presentations of the same disease, with both terms coded

9823. Traditionally the lymphoma diagnosis was staged with the Ann Arbor staging system and it is now

staged with the Lugano classification. In North America, CLL was staged with the Rai system.

Note 2: Rai stage is only applicable for CLL, in which the bone marrow and/or peripheral blood are

involved (primary site C421 for bone marrow, see Hematopoietic Manual, Module 3: PH 5, 6).

If primary site is not C421, code 5

Note 3: Physician statement of presence or absence of adenopathy should be used to code this data

item.

Physician’s statement regarding the presence of adenopathy (present or absent) takes priority.

If a physician’s statement and imaging are both available and in disagreement, go with the

physician’s statement

If a physician’s statement is not available, use the definition of adenopathy in Note 3 to

determine if adenopathy is present or not

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Note 4: Adenopathy is defined as the presence of lymph nodes >1.5 cm on physical examination (PE)

and is part of the staging criteria.

Note 5: This data item is determined from physical exam alone. If a physical exam cannot be used to

detect adenopathy due to issues related to the patient’s obesity, a physician statement of peripheral

adenopathy based on a CT scan can be used.

A finding of retroperitoneal or mesenteric adenopathy on CT is not used in determining

adenopathy and does not affect the assigned stage

Note 6: If there is no mention of adenopathy (present or absent), code 9.

Note 7: The physician’s stated Rai stage always takes priority when there is conflicting information.

Code Description

0 Adenopathy not identified/not present

No lymph nodes > 1.5 cm

Physician states Rai Stage 0

1 Adenopathy present

Presence of lymph nodes > 1.5 cm

Physician stated Rai Stage I

5 Not applicable: Primary site is not C421

9 Not documented in medical record

Adenopathy not assessed or unknown if assessed

No Rai stage is documented in the record and there is no documentation

of adenopathy

Physician states Rai stage II-IV and there is no documentation of

adenopathy

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00795: Lymphoma-CLL/SLL (2018+)

3907: Organomegaly

Item Length: 1

NAACCR Item #: 3907

XML Parent-NAACCR ID: Tumor-organomegaly

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00795: Lymphoma-CLL/SLL (2018+)

Description

Organomegaly is defined as presence of enlarged liver and/or spleen on physical examination and is part

of the staging criteria for Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL).

Rationale

Organomegaly is a prognostic factor required for staging of CLL/SLL in AJCC 8

edition, Chapter 79

Hodgkin and Non-Hodgkin Lymphomas. It is a new data item for cases diagnosed 1/1/2018+.

See Rai Classification for additional information.

Coding Instructions and Codes

Note 1: For cases diagnosed 1/1/2018 and later, all cases of CLL and SLL will require both the Lugano

classification, which is captured in the AJCC stage group data item, and the five components of the

modified Rai staging system, which are captured in Site-Specific Data Items (adenopathy, anemia,

lymphocytosis, organomegaly, and thrombocytopenia)

The terms B-cell lymphocytic leukemia/chronic lymphocytic leukemia (CLL) and small lymphocytic

lymphoma (SLL) are different clinical presentations of the same disease, with both terms coded

9823. Traditionally the lymphoma diagnosis was staged with the Ann Arbor staging system and it is now

staged with the Lugano classification. In North America, CLL was staged with the Rai system.

Note 2: Rai stage is only applicable for CLL, in which the bone marrow and/or peripheral blood are

involved (primary site C421 for bone marrow, see Hematopoietic Manual, Module 3: PH 5, 6).

If primary site is not C421, code 5

Note 3: Physician statement of presence or absence of organomegaly should be used to code this data

item.

Note 4: Organomegaly is defined as presence of enlarged liver and/or spleen on physical examination

and is part of the staging criteria.

Note 5: This data item is determined from physical exam alone. If a physical exam cannot be used to

detect organomegaly due to issues related to the patient’s obesity, a physician statement of

organomegaly based on a CT scan can be used.

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Note 6: I If there is no mention of the presence or absence of organomegaly (hepatomegaly and

splenomegaly), code 9.

Both the liver and spleen mut be evaluated and determined to be normal to code 0. If only one

is evaluated and determined to be normal, code 9.

Note 7: The physician’s stated Rai stage always takes priority when there is conflicting information.

Code Description

0 Neither hepatomegaly (liver) nor splenomegaly (spleen) present

Physician states Rai Stage 0-I

1 Hepatomegaly (liver) and/or splenomegaly (spleen) present

Physician states Rai Stage II

5 Not applicable: Primary site is not C421

9 Not documented in medical record

Organomegaly (hepatomegaly and/or splenomegaly) not assessed or

unknown if assessed

No Rai stage is documented in the record and there is no documentation

of organomegaly

Physician states Rai stage III-IV and there is no documentation of

organomegaly

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00795: Lymphoma-CLL/SLL (2018+)

3811: Anemia

Item Length: 1

NAACCR Item #: 3811

XML Parent-NAACCR ID: Tumor-anemia

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00795: Lymphoma-CLL/SLL (2018+)

Description

Anemia is defined by a deficiency of red blood cells or of hemoglobin in the blood. In staging of Chronic

Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL), anemia is defined as Hgb <11.0 g/dL.

Rationale

Anemia is a prognostic factor required for staging of Chronic Lymphocytic Leukemia/Small Lymphocytic

Leukemia (CLL/SLL) in AJCC 8

edition, Chapter 79 Hodgkin and Non-Hodgkin Lymphomas. It is a new

data item for cases diagnosed 1/1/2018+.

See Rai Classification for additional information.

Coding Instructions and Codes

Note 1: For cases diagnosed 1/1/2018 and later, all cases of CLL and SLL will require both the Lugano

classification, which is captured in the AJCC stage group data item, and the five components of the

modified Rai staging system, which are captured in Site-Specific Data Items (adenopathy, anemia,

lymphocytosis, organomegaly, and thrombocytopenia)

The terms B-cell lymphocytic leukemia/chronic lymphocytic leukemia (CLL) and small lymphocytic

lymphoma (SLL) are different clinical presentations of the same disease, with both terms coded

9823. Traditionally the lymphoma diagnosis was staged with the Ann Arbor staging system and it is now

staged with the Lugano classification. In North America, CLL was staged with the Rai system.

Note 2: Rai stage is only applicable for CLL, in which the bone marrow and/or peripheral blood are

involved (primary site C421 for bone marrow, see Hematopoietic Manual, Module 3: PH 5, 6).

If primary site is not C421, code 5

Note 3: Anemia is defined as Hgb <11.0 g/dL and is part of the staging criteria.

Use the cut points listed in the table regardless of the lab’s reference range

A lab value expressed in grams per liter (g/L) is 10 times the same value expressed in g/dL;

therefore, the cut point of 11.0 g/dL is equivalent to 110 g/L

Note 4: Record this data item based on a blood test (CBC, hemoglobin & hematocrit, H&H) performed at

diagnosis (pre-treatment). In the absence of the lab test, a physician’s statement can be used.

Note 5: If there is no mention of anemia, or relevant lab results, code 9.

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Note 6: The physician’s stated Rai Stage always takes priority when there is conflicting information.

Code Description

0 Anemia not present

Hgb >=11.0 g/dL

Physician states Rai Stage 0-II

1 Anemia present

Hgb <11.0 g/dL

5 Not applicable: Primary site is not C421

6 Lab value unknown, physician states patient is anemic

Physician states Rai Stage III

7 Test ordered, results not in chart

9 Not documented in medical record

Anemia not assessed or unknown if assessed

No Rai stage is documented in the record and there is no

documentation of anemia

Physician states Rai stage IV and there is no documentation of anemia

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00795: Lymphoma-CLL/SLL (2018+)

3933: Thrombocytopenia

Item Length: 1

NAACCR Item #: 3933

XML Parent-NAACCR ID: Tumor-thrombocytopenia

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00795: Lymphoma-CLL/SLL (2018+)

Description

Thrombocytopenia is defined by a deficiency of platelets in the blood. In staging of Chronic Lymphocytic

Leukemia/Small Lymphocytic Leukemia (CLL/SLL), thrombocytopenia is defined as Platelets (Plt) <

100,000/ L.

Rationale

Thrombocytopenia is a prognostic factor required for staging of Chronic Lymphocytic Leukemia/Small

Lymphocytic Leukemia (CLL/SLL) in AJCC 8

edition, Chapter 79 Hodgkin and Non-Hodgkin Lymphomas.

It is a new data item for cases diagnosed 1/1/2018+.

See Rai Classification for additional information.

Coding Instructions and Codes

Note 1: For cases diagnosed 1/1/2018 and later, all cases of CLL and SLL will require both the Lugano

classification, which is captured in the AJCC stage group data item, and the five components of the

modified Rai staging system, which are captured in Site-Specific Data Items (adenopathy, anemia,

lymphocytosis, organomegaly, and thrombocytopenia)

The terms B-cell lymphocytic leukemia/chronic lymphocytic leukemia (CLL) and small lymphocytic

lymphoma (SLL) are different clinical presentations of the same disease, with both terms coded

9823. Traditionally the lymphoma diagnosis was staged with the Ann Arbor staging system and it is now

staged with the Lugano classification. In North America, CLL was staged with the Rai system.

Note 2: Rai stage is only applicable for CLL, in which the bone marrow and/or peripheral blood are

involved (primary site C421 for bone marrow, see Hematopoietic Manual, Module 3: PH 5, 6).

If primary site is not C421, code 5

Note 3: Thrombocytopenia is defined as platelets (Plt) <100,000/ L. This is part of the Modified Rai

Staging System and not included as part of the AJCC Lugano staging.

Use the cut points listed in the table regardless of the lab’s reference range

For cases that document platelet count in SI (Systeme Internationale) units as any of 10*9/L,

10^9/L, or 10E9/L, the cut point of 100,000 cells/µL is equivalent to (100 cells x 10*9/L), (100

cells x 10^9/L, or (100 cells x 10E9/L)

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Note 4: Record this data item based on a blood test (CBC and differential) performed at diagnosis (pre-

treatment). In the absence of the lab test, a physician’s statement can be used.

Note 5: If there is no mention of thrombocytopenia, or the relevant lab tests, code 9.

Note 6: The physician’s stated Rai Stage always takes priority when there is conflicting information.

Code Description

0 Thrombocytopenia not present

Platelets (Plt) >=100,000/ L

Physician states Rai Stage 0-III

Thrombocytopenia present

Platelets (Plt) < 100,000/ L

5 Not applicable: Primary site is not C421

6 Lab value unknown, physician states thrombocytopenia is present

Physician states Rai Stage IV

7 Test ordered, results not in chart

9 Not documented in medical record

Thrombocytopenia not assessed or unknown if assessed

No Rai stage is documented in the record and there is no documentation

of thrombocytopenia

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00795: Lymphoma-CLL/SLL (2018+)

3955: Derived Rai stage

Item Length: 1

NAACCR Item #: 3955

XML Parent-NAACCR ID: Tumor-derivedRaiStage

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00795: Lymphoma-CLL/SLL (2018+)

Description

This data item stores the Derived Rai stage value derived from the values coded in the following SSDIs

for the Lymphoma-CLL/SLL schema (9823/3).

3885: Lymphocytosis

3804: Adenopathy

3907: Organomegaly

3811: Anemia

3933: Thrombocytopenia

The Rai stage is only applicable for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

(CLL/SLL) (9823/3) cases where the primary site is bone marrow (C421). For cases with a primary site

other than bone marrow (C421), the derived Rai stage will be 8 and all the SSDIs will be coded to 5.

Derivation will be run on all cases diagnosed 1/1/2018 and forward.

Rationale

The Derived Rai stage can be used to evaluate disease spread at diagnosis, treatment patterns and

outcomes over time.

Rai Stage Rai Code

Description

0 0 Lymphocytosis

1 I Lymphocytosis and Adenopathy

Lymphocytosis and

Organomegaly

(Adenopathy is any value other than 5)

III

Lymphocytosis and Anemia

(Adenopathy and Organomegaly are any value other than 5)

Lymphocytosis and Thrombocytopenia

(Adenopathy, Organomegaly and Anemia are any value other than 5)

8 N/A Does not apply, primary site not bone marrow (C421)

(All 5 SSDIs should be set to 5)

Unknown(All 5 SSDIs are 9 or blank

)

At least one is set to 9 OR

Lymphocytosis is 0,7,9 OR

Lymphocytosis is blank and one of the other SSDIs is a value other than 5 or 9)

This field should be left blank for all cases diagnosed prior to 2018, for schemas other than 00795, and

when not required by standard setter.

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00811: Mycosis Fungoides (2018+)

3910: Peripheral Blood Involvement

Item Length: 1

NAACCR Item #: 3910

XML Parent-NAACCR ID: Tumor-peripheralBloodInvolvement

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00811: Mycosis Fungoides (2018+)

Description

Peripheral blood involvement, summarized in “B category”, refers to the percentage of peripheral blood

lymphocytes that are atypical (Sezary) cells and whether they are “Clone negative” or “Clone positive.”

Rationale

Peripheral blood involvement is a prognostic factor required in AJCC 8

edition, Chapter 81 Primary

Cutaneous Lymphomas, for staging of Mycosis Fungoides and Sezary Syndrome. It was previously

collected as Mycosis Fungoides, CS SSF #1.

Definition

Mycosis fungoides is the most common type of primary cutaneous T-cell lymphoma. Sezary syndrome is

a more aggressive type of primary cutaneous T-cell lymphoma in which a specific type of malignant T

lymphocytes (Sezary cells) are present in the circulating blood. Staging of mycosis fungoides includes

analysis of the circulating blood for Sezary cells. This analysis can be done by microscopy or flow

cytometry. Results of microscopy are reported as counts of Sezary cells per cubic millimeter or the

percentage of Sezary cells as a proportion of total lymphocytes. Flow cytometry looks for specific cell

surface markers such as CD26.

Information about peripheral blood involvement and T-cell clonality identified by polymerase chain

reaction (PCR) or Southern blot analysis is combined in a “B” category unique to mycosis fungoides

staging in the TNM system.

The basic categories are B0 (no significant blood involvement); B1 (low blood tumor burden); and B2

(high blood tumor burden). Any mention of B2 puts the case into Stage IV. B0 and B1 are

subcategorized by clonality.

Code a statement of peripheral blood involvement and clonality (if given) as reported by the clinician

from tissue and/or blood samples. If the physician does not provide a B rating but counts or

percentages of neoplastic cells, flow cytometry test results, and/or clonality test results are performed,

use the appropriate code for the amount of blood involvement with “clone unknown.”

Additional Information

Source documents: pathology report, clinical laboratory reports of blood analysis (tissue and

blood samples)

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Other names: Peripheral blood involvement: circulating Sezary cells, T-cell clonality: T-cell

receptor (TCR) gene rearrangement, Monoclonal: clone +, clone positive, Polyclonal: clone –,

clone negative

Coding Instructions and Codes

Note 1: The categories for peripheral blood involvement (B rating) are

B0: No significant blood involvement

B1: Low blood tumor burden

B2: High blood tumor burden

Note 2: Physician statement of B rating can be used to code this data item.

Note 3: If counts or percentages of neoplastic cells and clonality test results are available, but a B rating

is not stated by the physician, the registrar can use the information and assign a B rating and code this

data item accordingly. If this information is not available, code 9.

Code Description B Map

0 Absence of significant blood involvement

5% or less of peripheral blood lymphocytes are atypical (Sezary) cells

Clone unknown

Stated as B0

1 Absence of significant blood involvement

5% or less of peripheral blood lymphocytes are atypical (Sezary) cells

Clone negative

Stated as B0a

B0a

2 Absence of significant blood involvement:

5% or less of peripheral blood lymphocytes are atypical (Sezary) cells

Clone positive

Stated as B0b

B0b

3 Low blood tumor burden

More than 5% of peripheral blood lymphocytes are atypical (Sezary) cells

but does not meet the criteria of B2

Clone unknown

Stated as B1

4 Low blood tumor burden

More than 5% of peripheral blood lymphocytes are atypical (Sezary) cells

but does not meet the criteria of B2

Clone negative

Stated as B1a

B1a

5 Low blood tumor burden

More than 5% of peripheral blood lymphocytes are atypical (Sezary) cells

but does not meet the criteria of B2

Clone positive

Stated as B1b

B1b

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Code Description B Map

6 High blood tumor burden

Greater than or equal to 1000 Sezary cells per microliter (uL)

Clone positive

Stated as B2

7 Test ordered, results not in chart BX

Not documented in

medical record

Peripheral Blood Involvement not assessed or unknown if assessed

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00821: Plasma Cell Myeloma (2018+)

RISS Stage (Plasma Cell Myeloma)

Definition

The Revised International Staging System (RISS or R-ISS) is now used to stage plasma cell myeloma

(9732/3), using several different criteria. The stages are based on the absence or presence of the

following criteria

3931: Serum Beta-2 Microglobulin Pretreatment Level

3930: Serum Albumin Pretreatment Level

3857: High Risk Cytogenetics

3869: LDH Level

Required for Staging: The AJCC Staging System Plasma Cell Myeloma and Plasma Cell Disorders (9732/3

only) and EOD.

Note: RISS stage is not applicable for the descriptions of plasma multiple myeloma that are

listed in the codes 1 and 9 in the SSDI Schema Discriminator 1: Plasma Cell Myeloma

Terminology. If you have coded 1 or 9 for this Schema Discriminator, the four data items listed

above are BLANK.

The RISS stages are

Stage I: Serum Beta-2-microglobulin <3.5 mg/L and serum albumin > 3.5 g/dL and no high-risk

cytogenetics and Normal LDH

Stage II: Not R-ISS I or III

Stage III: Serum Beta-2-microglobulin > 5.5 mg/L and high-risk cytogenetics and/or high LDH

Additional Information

Other names: R-ISS

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00821: Plasma Cell Myeloma (2018+)

3926: Schema Discriminator 1: Plasma Cell Myeloma Terminology

Item Length: 1

NAACCR Item #: 3926

XML Parent-NAACCR ID: Tumor-schemaDiscriminator1

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00821: Plasma Cell Myeloma (2018+)

Definition

A variety of descriptive terms refer to early phases of plasma cell myeloma, all of which are coded to

9732, and reportable based on the 2010 Hematopoietic and Lymphoid Neoplasms coding rules. Per AJCC

edition, not all terms are applicable for the Revised International Staging System (RISS or R-ISS) stage.

This schema discriminators collects the specific terminology used to describe the plasma cell myeloma

at the time of diagnosis.

Code the terminology used by the physician to describe the plasma cell myeloma from any

documentation in the medical record. If other terminology is used later in the course of the disease to

describe more aggressive plasma cell myeloma, do not change the code in the schema discriminator.

Coding Instructions and Codes

Note 1: Several terms are used to characterize plasma cell myeloma at the time of diagnosis. All these

terms are reportable according to the new Hematopoietic and Lymphoid Neoplasms rules effective for

cases diagnosed January 1, 2010 and later.

Note 2: Select the code based on the terminology specified by the physician in the record. Do not

attempt to determine the correct terminology based on the diagnostic criteria in the AJCC 8

table 82.1.

Note 3: Do not change the discriminator code if a term used later indicates progression to a more

aggressive disease course.

Note 4: If diagnosis is plasma cell leukemia variant and is diagnosed concomitant with plasma cell

myeloma, code 0.

Code Description Stage Table

0 Plasma cell myeloma (PCM)

Multiple myeloma

Myeloma, NOS

Non-secretory myeloma

Ultra-High-Risk Smoldering MM (SMM)

RISS Stage

1 Smoldering plasma cell myeloma (SPCM)

Asymptomatic plasma cell myeloma

Early myeloma

Evolving myeloma

No RISS Stage

9 Other terminology describing myeloma

Unknown terminology used

No RISS Stage

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00821: Plasma Cell Myeloma (2018+)

3931: Serum Beta-2 Microglobulin Pretreatment Level

Item Length: 1

NAACCR Item #: 3931

XML Parent-NAACCR ID: Tumor-serumBeta2MicroglobulinPretxLvl

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00821: Plasma Cell Myeloma (2018+)

Description

Serum Beta-2 Microglobulin is a protein that is found on the surface of many cells and plentiful on the

surface of whi -2)

-2) Microglobulin level is a prognostic factor for

plasma cell myeloma.

Rationale

Serum Beta-2 Microglobulin Pretreatment Level is a prognostic factor required in AJCC 8

edition,

Chapter 82 Plasma Cell Myeloma and Plasma Cell Disorders, for staging of plasma cell myeloma. It is a

new data item for cases diagnosed 1/1/2018+.

See RISS Stage (Plasma Cell Myeloma) for additional information.

Coding Instructions and Codes

Note 1: Serum microglobulin is part of the Revised International Staging (RISS). Use the cut points listed

in the table below regardless of the lab’s reference range.

Note 2: Record this data item based on a blood test performed at diagnosis (pre-treatment). In the

absence of the lab test, a physician’s statement of the exact value can be used. Use the highest value

available.

Note 3: If there is no mention of the serum beta-2 microglobulin, code 9.

Note 4: If Schema Discriminator 1: Plasma Cell Myeloma Terminology is coded to 1 or 9, code 5.

Code Description

0 -microglobulin < 3.5 mg/L

1 -

2 -

5 Schema Discriminator 1: Plasma Cell Myeloma Terminology coded to 1 or 9

7 Test ordered, results not in chart

9 Not documented in medical record

Serum Beta-2 Microglobulin Pretreatment Level not assessed or unknown

if assessed

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00821: Plasma Cell Myeloma (2018+)

3930: Serum Albumin Pretreatment Level

Item Length: 1

NAACCR Item #: 3930

XML Parent-NAACCR ID: Tumor-serumAlbuminPretreatmentLevel

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00821: Plasma Cell Myeloma (2018+)

Description

Albumin is the most abundant protein in human blood plasma. Serum albumin pretreatment level is a

prognostic factor for plasma cell myeloma.

Rationale

Serum albumin pretreatment level is a prognostic factor required in AJCC 8

edition, Chapter 82 Plasma

Cell Myeloma and Plasma Cell Disorders, for the Revised International Staging System (RISS). It is a new

data item for cases diagnosed 1/1/2018+.

See RISS Stage (Plasma Cell Myeloma) for additional information.

Coding Instructions and Codes

Note 1: 3.5 g/dL and is part of the Revised International Staging

System (RISS).

Use the cut points listed in the table regardless of the lab’s reference range

A lab value expressed in grams per liter (g/L) is 10 times the same value expressed in g/dL;

therefore, the cut point of 3.5 g/dL is equivalent to 35 g/L.

Note 2: Record this data item based on a blood test performed at diagnosis (pre-treatment). In the

absence of the lab test, a physician’s statement of the exact value can be used. Do not use findings from

a urine test.

Note 3: If there is no mention of the serum albumin, code 9.

Note 4: If Schema Discriminator 1: Plasma Cell Myeloma Terminology is coded to 1 or 9, code 5.

Code Description

0 Serum albumin <3.5 g/dL

5 Schema Discriminator 1: Plasma Cell Myeloma Terminology coded to 1 or 9

7 Test ordered, results not in chart

9 Not documented in medical record

Serum Albumin Pretreatment Level not assessed or unknown if assessed

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00821: Plasma Cell Myeloma (2018+)

3857: High Risk Cytogenetics

Item Length: 1

NAACCR Item #: 3857

XML Parent-NAACCR ID: Tumor-highRiskCytogenetics

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00821: Plasma Cell Myeloma (2018+)

Description

High Risk Cytogenetics is defined as one or more of t(4;14), t(14;16), or del 17p identified from FISH test

results and is part of the staging criteria for plasma cell myeloma.

Rationale

High Risk Cytogenetics is a prognostic factor required in AJCC 8

edition, Chapter 82 Plasma Cell

Myeloma and Plasma Cell Disorders, for staging of plasma cell myeloma. It is a new data item for cases

diagnosed 1/1/2018+.

See RISS Stage (Plasma Cell Myeloma) for additional information.

Coding Instructions and Codes

Note 1: Physician statement of presence or absence of high-risk cytogenetics can be used to code this

data item.

Note 2: Record this data item based on physician statement or FISH test interpretation performed at

diagnosis (pre-treatment)

Note 3: If the presence/absence of high-risk cytogenetics determined by available test results differs

from the physician statement of presence/absence, the physician’s statement takes precedence.

Note 4: If there is no mention of high risk cytogenetics, code 9.

Note 5: If Schema Discriminator 1: Plasma Cell Myeloma Terminology is coded to 1 or 9, code 5.

Code Description

0 High-risk cytogenetics not identified/not present

1 High-risk cytogenetics present

5 Schema Discriminator 1: Plasma Cell Myeloma Terminology coded to 1 or 9

7 Test ordered, results not in chart

9 Not documented in medical record

High Risk Cytogenetics not assessed or unknown if assessed

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00821: Plasma Cell Myeloma (2018+)

3869: LDH Level

Item Length: 1

NAACCR Item #: 3869

XML Parent-NAACCR ID: Tumor-ldhPretreatmentLevel

NAACCR Alternate Name: LDH (Lactate Dehydrogenase) Pretreatment Level

Active years: 2018+

Schema(s):

00821: Plasma Cell Myeloma (2018+)

Description

LDH (Lactate Dehydrogenase) is an enzyme involved in conversion of sugars to energy and present in

most cells in the body. Elevated LDH is an adverse prognostic factor for plasma cell myeloma and

melanoma of the skin.

Rationale

LDH (Lactate Dehydrogenase) Level is a prognostic factor required in AJCC 8

edition for Chapter 82

Plasma Cell Myeloma and Plasma Cell Disorders and Chapter 47 Melanoma Skin. For Plasma Cell

Myeloma, LDH is part of the RISS Stage and is new for cases diagnosed 1/1/2018+. For Melanoma Skin,

LDH is used to define the M subcategories and was previously collected as Melanoma Skin, SSF #4.

See RISS Stage (Plasma Cell Myeloma) for additional information.

Coding Instructions and Codes

Note 1: Use the reference ranges from your lab to determine if LDH is normal.

Note 2: Record this data item based on a blood test performed at diagnosis (pre-treatment). In the

absence of the lab test, a physician’s statement of the exact value or interpretation can be used. Use the

highest value available.

Note 3: If there is no mention of the LDH, code 9.

Note 4: If Schema Discriminator 1: Plasma Cell Myeloma Terminology is coded to 1 or 9, code 5.

Code Description

0 Normal LDH level

Low, below normal

1 Above normal LDH level; High

5 Schema Discriminator 1: Plasma Cell Myeloma Terminology coded to 1 or 9

7 Test ordered, results not in chart

9 Not documented in medical record

LDH (Lactate Dehydrogenase) Level not assessed or unknown if assessed

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00830: HemeRetic (2018+)

See 00790: Lymphoma

3926: Schema Discriminator 1: Histology Discriminator for 9591/3

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00830: HemeRetic (2018+)

3862: JAK 2

Item Length: 1

NAACCR Item #: 3862

XML Parent-NAACCR ID: Tumor-jak2

NAACCR Alternate Name: None

Active years: 2018+

Schema(s):

00830: HemeRetic (2018+)

Description

Janus Kinase 2 (JAK2, JAK 2) is a gene mutation that increases susceptibility to several myeloproliferative

neoplasms (MPNs). Testing for the JAK2 mutation is done on whole blood. Nearly all people with

polycythemia vera, and about half of those with primary myelofibrosis and essential thrombocythemia,

have the mutation. JAK2 analysis continues to increase in use for hematopoietic neoplasms.

Rationale

JAK2 can be collected by the surveillance community for myeloproliferative neoplasms. Prior to 2018,

HemeRetic SSF#1 was used for JAK2.

Definition

JAK2, a gene found in all humans, is involved in the development of blood cells. If JAK2 has mutated, the

person is more susceptible to develop a myeloproliferative disorder (MPD). The JAK2 mutation, which is

acquired rather than inherited, is found in as many as 90% of patients with polycythemia vera (PV),

about half of patients with essential thrombocythemia (ET), and slightly fewer patients with primary

myelofibrosis (also known as agnogenic myeloid metaplasia and other terms). JAK2 is used by clinicians

to help classify MPDs. The most common histologies for which JAK-2 is tested are those listed above.

Registrars can use JAK2 information to help determine whether the MPD is reportable. JAK2 positivity

indicates a malignant (clonal, irreversible) reportable disease, but is not diagnostic of a specific MPD.

Additional tests, such as a bone marrow biopsy, are necessary to determine the specific MPD histology.

As the use of JAK2 increases and is investigated for other hematopoietic histologies, it also has future

potential for development of targeted therapeutics for the MPDs.

The principal JAK2 test looks for a change (mutation) in an amino acid at a specific place on the JAK2

gene called V617F. If the V617F test is negative, other JAK2 mutation tests, such as those in exon 12 or

13 may be ordered to investigate a possible diagnosis of polycythemia vera. (An exon is a segment of a

gene that contains instructions for making a protein.)

Coding guidelines

Code the result of the JAK2 test as documented in a laboratory test or elsewhere in the medical record.

Code this field for any hematopoietic, immunoproliferative, myeloproliferative, or myelodysplastic

disease for which JAK2 is tested. For those diseases where JAK2 is not mentioned in the record, or for a

HemeRetic schema disease such as leukemia where JAK2 is not normally tested, code as 9.

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Code 0 when the JAK2 test result is stated as negative.

Code 1 when the JAK2 test was performed and was positive for mutation V617F in exon 14.

Code 2 when the JAK2 test was performed and was positive for mutation of exon 12.

Code 3 when the JAK2 test was performed and was positive for another specified mutation.

Code 4 when the JAK2 test was performed and was positive for more than one mutation.

Code 7 when there is a statement in the record that the test was ordered but the results are not

available.

Code 9 when

o There is no information in the medical record about JAK2 testing

o The results of JAK2 testing are unknown

Additional Information

Source documents: clinical laboratory test (whole blood), reference laboratory test; anatomic

pathology (polymerase chain reaction test on bone marrow)

Other names: Janus kinase 2 gene, JAK2 V617F, JAK2 exon 12, JAK2 exon13

Coding Instructions and Codes

Note 1: Physician statement of JAK2 can be used to code this data item when no other information is

available.

Note 2: Janus Kinase 2 (JAK2, JAK 2) is a gene mutation that increases susceptibility to several

myeloproliferative neoplasms (MPNs). Testing for the JAK2 mutation is done on whole blood. Nearly all

people with polycythemia vera, and about half of those with primary myelofibrosis and essential

thrombocythemia, have the mutation.

Note 3: Record JAK2 for any hematopoietic neoplasm. It is most commonly used for the following

histologies:

Polycythemia Vera (9950/3)

Primary myelofibrosis (9961/3)

Essential Thrombocytopenia (9962/3)

Chronic myelomonocytic leukemia (9945/3)

Code Description

0 JAK2 result stated as negative

1 JAK2 positive for mutation V617F WITH or WITHOUT other mutations

2 JAK2 positive for exon 12 mutation

3 JAK2 positive for other specified mutation

4 JAK2 positive for more than one mutation other than V617F

JAK2 positive NOS

Specific mutation(s) not stated

7 Test ordered, results not in chart

8 Not applicable: Information not collected for this case

(If this item is required by your standard setter, use of code 8 will result in an edit error.)

9 Not documented in medical record

JAK2 not assessed or unknown if assessed

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99999: Ill-Defined Other (2018+)

See 00060: Cervical Lymph Nodes and Unknown Primary Tumors of the Head and Neck

3926: Schema Discriminator 1: Occult Head and Neck Lymph Nodes

o Primary Site C760 only

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ALPHABETICAL INDEX

Adenoid Cystic Basaloid Pattern, 394

Adenopathy (Rai Classification: CLL/SLL), 427

AFP Post-Orchiectomy Lab Value, 338

AFP Post-Orchiectomy Range, 340

AFP Pre-Orchiectomy Lab Value, 334

AFP Pre-Orchiectomy Range, 336

AFP Pretreatment Interpretation, 120

AFP Pretreatment Lab Value, 119

Anemia (Rai Classification: CLL/SLL), 431

B Symptoms, 416

Bilirubin Pretreatment Total Lab Value, 124

Bilirubin Pretreatment Unit of Measure, 126

Bone Invasion, 164

Brain Molecular Markers, 398

Breslow Tumor Thickness, 185

CA-125 Pretreatment Interpretation, 298

CEA Pretreatment Interpretation, 96

CEA Pretreatment Lab Value, 94

Chromosome 19q: Loss of Heterozygosity (LOH),

403

Chromosome 1p: Loss of Heterozygosity (LOH),

401

Chromosome 3 Status, 375

Chromosome 8q Status, 377

Circumferential Resection Margin (CRM), 98

Creatinine Pretreatment Lab Value, 127

Creatinine Pretreatment Unit of Measure, 129

Esophagus and EGJ Tumor Epicenter, 86

Estrogen Receptor Percent Positive or Range,

204

Estrogen Receptor Summary, 202

Estrogen Receptor Total Allred Score, 206

Extranodal Extension Clin (non-Head and Neck),

177

Extranodal Extension Head and Neck Clinical, 56

Extranodal Extension Path (non-Head and

Neck), 179

Extravascular Matrix Patterns, 379

Fibrosis Score, 131

FIGO Stage (Adenosarcoma), 295

FIGO: Cervix, 274

FIGO: Corpus Carcinoma and Carcinosarcoma,

279

FIGO: Gestational Trophoblastic Tumors

(Placenta), 304

FIGO: Ovary, Fallopian Tube, and Peritoneal

Carcinoma, 296

FIGO: Vagina, 266

FIGO: Vulva, 254

Gestational Trophoblastic Prognostic Scoring

Index, 305

Gleason Patterns Clinical, 315

Gleason Patterns Pathological, 320

Gleason Score Clinical, 318

Gleason Score Pathological, 323

Gleason Tertiary Pattern, 325

hCG Post-Orchiectomy Lab Value, 346

hCG Post-Orchiectomy Range, 348

hCG Pre-Orchiectomy Lab Value, 344

hCG Pre-Orchiectomy Range, 345

HER2 IHC Summary, 217

HER2 ISH Dual Probe Copy Number, 225

HER2 ISH Dual Probe Ratio, 227

HER2 ISH Single Probe Copy Number, 223

HER2 ISH Summary, 219

HER2 Overall Summary, 221

Heritable Trait, 390

High Risk Cytogenetics, 443

High Risk Histologic Features, 79

HIV Status, 418

International Normalized Ratio, 130

Invasion Beyond Capsule, 360

Ipsilateral Adrenal Gland Involvement, 364

JAK 2, 446

Ki-67, 242

KIT Gene Immunohistochemistry, 173

KRAS, 101

LDH Post-Orchiectomy Range, 353

LDH Pre-Orchiectomy Range, 352

LDH Pretreatment Lab Value, 192

LDH Pretreatment Level, 194

LDH Upper Limits of Normal, 195

LN Assessment Method Femoral-Inguinal, 257

LN Assessment Method Para-Aortic, 267, 269

LN Assessment Method Pelvic, 261

LN Distant Assessment Method, 272

LN Distant: Mediastinal, Scalene, 271

LN Head and Neck Levels I-III, 61

LN Head and Neck Levels IV-V, 63

LN Head and Neck Levels VI-VII, 65

LN Head and Neck Other, 67

LN Isolated Tumor Cells (ITC), 181

LN Laterality, 263

LN Positive Axillary Level I-II, 244

LN Status Femoral-Inguinal, Para-Aortic, Pelvic,

255, 259

Lymphocytosis (Rai Classification: CLL/SLL), 425

Major Vein Involvement, 362

457 | P a g e Site-Specific Data Item (SSDI) Manual Version 3.0

Measured Basal Diameter, 381

Measured Thickness, 383

Methylation of O6-Methylguanine-

Methyltransferase, 405

Microsatellite Instability (MSI), 104

Microvascular Density, 385

Mitotic Count Uveal Melanoma, 387

Mitotic Rate Melanoma, 190

Multigene Signature Method, 231

Multigene Signature Results, 233

NCCN International Prognostic Index (IPI), 420

Number of Cores Examined, 329

Number of Cores Positive, 327

Number of Examined Para-Aortic Nodes, 284

Number of Examined Pelvic Nodes, 288

Number of Positive Para-Aortic Nodes, 282

Number of Positive Pelvic Nodes, 286

Oncotype Dx Recurrence Score-DCIS, 237

Oncotype Dx Recurrence Score-Invasive, 239

Oncotype Dx Risk Level-DCIS, 238

Oncotype Dx Risk Level-Invasive, 241

Organomegaly (Rai Classification: CLL/SLL), 429

Percent Necrosis Post Neoadjuvant, 160

Perineural Invasion, 107

Peripheral Blood Involvement, 436

Peritoneal Cytology, 290

Pleural Effusion, 157

Primary Sclerosing Cholangitis, 134

Profound Immune Suppression, 183

Progesterone Receptor Percent Positive or

Range, 210

Progesterone Receptor Summary, 208

Progesterone Receptor Total Allred Score, 212

PSA (Prostatic Specific Antigen) Lab Value, 309

Residual Tumor Volume Post Cytoreduction,

300

Response to Neoadjuvant Therapy, 247

S Category Clinical, 355

S Category Pathological, 357

Sarcomatoid Features, 366

Schema Discriminator 1 (Histology

Discriminator for 9591/3), 415

Schema Discriminator 1:

BileDuctsDistal/BileDuctsPerihilar/CysticDuct,

138

Schema Discriminator 1: Lacrimal Gland/Sac,

393

Schema Discriminator 1: Melanoma Ciliary

Body/Melanoma Iris, 374

Schema Discriminator 1:

Nasopharynx/Pharyngeal Tonsil, 73

Schema Discriminator 1: Occult Head and Neck

Lymph Nodes, 49

Schema Discriminator 1: Plasma Cell Myeloma

Terminology, 440

Schema Discriminator 1: Primary Peritoneum

Tumor, 172

Schema Discriminator 1: Thyroid

Gland/Thyroglossal Duct, 412

Schema Discriminator 1: Urethra/Prostatic

Urethra, 368

Schema Discriminator 2: Histology Discriminator

for 8020/3, 85

Schema Discriminator 2: Oropharyngeal p16, 75

Separate Tumor Nodules, 147

Serum Albumin Pretreatment Level, 442

Serum Beta-2 Microglobulin Pretreatment

Level, 441

Thrombocytopenia (Rai Classification: CLL/SLL),

433, 435

Tumor Deposits, 109

Tumor Growth Pattern, 136

Ulceration, 188

Visceral and Parietal Pleural Invasion, 150, 153