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CHAPTER III:

STANDARDS FOR TUMOR INCLUSION AND REPORTABILITY

Due to continued efforts by standard-setting organizations, facility-based registries and population-based central registries now follow nearly identical standards for determining reportable tumors that are to be included in the registry; however, some differences in reportability remain. CoC stipulates the tumors that must be included in accredited facility registries to meet their standards. Most population-based registries follow the standards set by SEER and/or NPCR and enforce these standards on the facilities that report data to them under state cancer reporting laws. The Cancer Program Standards,27 the CoC STORE manual,2 SEER Program Code manuals,3,8 NPCR Program Announcement,36 and the Canadian Cancer Registry Collection Documentationshould be consulted for more details.

Standards for tumor reportability are defined by the following criteria:

Reference Date

The reference date is the effective date when cancer registration starts in a specified at-risk population or in a specific facility. It is not the date the registry is organized or the date work begins. Tumors diagnosed on or after the reference date must be included. The reference date typically begins on January 1 of a calendar year, but sometimes it is another date. It is important to be aware that the reference date of the regional, state or provincial/territorial registry may precede the reference date set by cancer registry hospitals or other individual facilities. If the regional, state or provincial/territorial registry is established by law, reporting entities will be required to submit their cases in accordance with the law regardless of their facility reference date.

Residency

For a population-based registry, it is essential to include all tumors occurring in the at-risk population, and rules must be in place for determining the members of that population. The goal is to use the same rules for the patients' demographic data at the time of diagnosis as those used by the Census Bureau in enumerating the population. For example, a population-based registry must have rules for determining residency of part-year residents, institutionalized persons, homeless persons, military personnel, and students. For Canadian registries see appendix T of the Canadian Cancer Registry Collection Documentation5 for specific instructions.

NAACCR recommends that population-based registries include in their database tumor reports of non-residents from facilities in their catchment areas to:

  • Share tumor information with the residents' population-based registry that otherwise may go unreported
  • Facilitate death clearance and other record linkages
  • Allow preparation of complete and accurate reports to individual facilities

Hospital-based registries are less concerned with residency of the patient than the reason for admission, and hospital registries might not collect data for certain categories of patients that the central registry must include, such as patients admitted to a hospice unit or transient patients who receive interim care to avoid interrupting a course of therapy. Also, CoC does not require complete abstracting of tumors that are “non-analytic” for the facility. Therefore, for the central registry, clear rules that are well documented, widely distributed, and accepted are essential to prevent missed case reports (source records).

In Utero Diagnosis

Diagnoses made in utero are reportable if the pregnancy results in a live birth. In absence of documentation of stillbirth, abortion or fetal death, assume there was a live birth and report the case. When a reportable diagnosis is confirmed prior to birth and disease is not evident at birth due to regression, accession the case based on the pre-birth diagnosis.

Reportable List

CoC, NPCR, SEER and CCCR have achieved greater consensus on reportable tumors in the past few years (see Table 2). For all tumors diagnosed from January 1, 1992, through December 31, 2000, all three U.S. standard setters (CoC, NPCR, and SEER) required the inclusion of all neoplasms in the International Classification of Diseases for Oncology, Second Edition17 (ICD-O-2) with a behavior code of 2 or 3 (in situ or malignant), with the exception of squamous cell and basal cell carcinoma of the skin and carcinoma in situ of the cervix uteri since 1996. (See the CARCINOMA IN SITU OF THE CERVIX, CIN and THE BETHESDA SYSTEM Section later in this Chapter). The CCCR adopted the ICD-O-217 in 1992.

For all tumors diagnosed on or after January 1, 2001, all four organizations require the inclusion of all neoplasms in the International Classification of Diseases for Oncology, Third Edition16 (ICD-O-3) with a behavior code of 2 or 3 (in situ or malignant), with the exception of squamous cell and basal cell carcinomas of the skin (C44._) with histologies 8000-8005, 8010-8046, 8050-8084, 8090-8110, prostatic intraepithelial neoplasia (PIN) III, carcinoma in situ (CIS) of the cervix, and cervical intraepithelial neoplasia (CIN) III. Morphology code 9421 (juvenile astrocytoma, pilocytic astrocytoma, or piloid astrocytoma), with a behavior code of 1 (borderline) in ICD-O-3, is reportable as 9421/3. Morphology code 9751 (Langerhans cell histiocytosis NOS, cases diagnosed on or after 1/1/2010, Morphology code 9831 T-cell large granular lymphocytic leukemia/Chronic lymphoproliferative disorder of NK-cells, cases diagnosed on or after 1/1/2010, Morphology code 9975 Myeloproliferative neoplasm, unclassifiable/Myelodysplastic/Myeloproliferative neoplasm, unclassifiable, cases diagnosed on or after 1/1/2010, and Morphology code 8240 Carcinoid tumor, NOS of appendix (C18.1), cases diagnosed on or after 1/1/2015. Prior to 2003, basal and squamous skin cancers that were AJCC stage group II or higher at diagnosis were reportable to CoC regardless of the site. Prior to 2007, CIS of the cervix, CIN III, and PIN III were reportable to CCCR.

In addition, the three U.S. organizations require the inclusion of all non-malignant primary intracranial and central nervous system (CNS) tumors diagnosed on or after January 1, 2004. Specifically, non-malignant, primary intracranial and CNS tumors of any morphology in ICD-O-316 having a behavior code of 0 or 1 (benign/ borderline) occurring in the following sites: brain, meninges, spinal cord, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct are reportable (see Table 3). The CCCR requires inclusion of all non-malignant primary intracranial and central nervous system (CNS) tumors diagnosed on or after January 1, 1992. Specifically, non-malignant primary intracranial and CNS tumors of any morphology in ICD-O-316 having a behavior code of 0 or 1 (benign or borderline) occurring in the following sites: brain, meninges, spinal cord, cranial nerves and other parts of the CNS are reportable (see Canadian Cancer Registry Collection Documentation5). As of June 1, 2007, this was expanded to include the pituitary gland, pineal gland, and craniopharyngeal duct.

In Situ/Invasive

It is important to distinguish between the morphologic condition of in situ as it is represented in ICD-O-2 or ICD-O-3 behavior codes and Tis as it is defined for the purpose of prognostic staging in the AJCC Cancer Staging Manual. Some morphologic and disease descriptive terms that are invasive in ICD-O-2/ICD-O-3 or localized in the SEER Summary Staging Guide/SEER Summary Staging Manual 2000 and the Summary Stage 2018 (SS2018) are Tis in the AJCC Cancer Staging Manual. Some examples are

  • Paget's disease of the nipple (8540/3) (an “invasive” code in ICD-O-2 and ICD-O-3) with no underlying tumor is classified as Tis in AJCC Eighth Edition.
  • Lobular Carcinoma in situ (LCIS) is removed from TNM staging in the AJCC Eighth Edition, but is still reportable and should be abstracted and coded according to SS2018 and EOD Primary Tumor 2018.
  • For colon/rectum, “invasion of the lamina propria” (intramucosal) with no extension through the muscularis mucosae into the submucosa is classified as Tis according to AJCC Eighth Edition and EOD Primary Tumor 2018 but localized in SEER Summary Stage 2018

Some tumors classified as invasive in the behavior code can be classified as Tis or Stage 0 when staged according to AJCC Eighth Edition. These differences should be considered when data are being compared.

Multiple Primary Rules

SEER rules have been the de facto standard for determining the number of primary cancers in the U.S. for both central and hospital-based registries. The 2018 Solid Tumor Rules replace the 2007 Multiple Primary and Histology (MP/H) Rules (see
https://seer.cancer.gov/tools/solidtumor/
) for the following eight site groups: Head & Neck, Colon (includes rectosigmoid and rectum for cases diagnosed 01/01/2018 and forward), Lung, Breast, Kidney, Urinary Sites, Non-malignant CNS, and Malignant CNS and Peripheral Nerves.


The 2007 Multiple Primary & Histology Rules remain in effect for the other sites not listed above effective with cases diagnosed 01/01/2007 to 12/31/2020. The cutaneous melanoma site rules will be revised for 2021 implementation to incorporate the
WHO Classification of Skin Tumours
, 4th Edition and the Other site rules will be revised to include GYN, soft tissue, thyroid and other site specific solid tumors for 2022 implementation.


CCR rules were the Canadian standard for the Canadian Cancer Registry database between 1992 and 2006. See the Canadian Cancer Registry Collection Documentation 5 for details. For cases diagnosed on or after January 1, 2007, the CCR adopted the
SEER 2007 Multiple Primary and Histology Coding Rules
.
4
Until all registries in Canada adopt the same set of rules to determine multiple primaries, the Canadian Cancer Registry publishes data nationally using the IARC multiple primary rules. The IARC rules have the effect of defining fewer cases than do any of the US multiple primary rules. A computer algorithm is available through IACR/IARC which identifies which U.S. cases would not be reportable under IACR/IARC multiple primary rules.


A rule requiring that an invasive tumor diagnosed more than two months after an in situ tumor of the same site be reported as a subsequent primary was reviewed by the Uniform Data Standards Committee and adopted on April 26, 1994, effective with tumors diagnosed in 1995 and later. This rule remains in effect and is incorporated into the 2018 Solid Tumor Rules as follows:

An invasive tumor following an in situ tumor more than 60 days after diagnosis is a multiple primary.

Note 1: The purpose of this rule is to ensure that the case is counted as an incident (invasive) case when incidence data are analyzed.

Note 2: Abstract as multiple primaries even if the medical record/physician states it is recurrence or progression of disease.4

This important rule affects how the tumor will be counted in published statistics. With the exception of bladder, in situ tumors are not usually included in published incidence rates. Without the reporting of these invasive cancers per the rules above, rates of invasive breast cancer would be underreported. CoC, with its emphasis on clinical data, did not adopt this exception to the general rule until the 2007 MP/H rules were implemented.

In the Canadian Cancer Registry database 1992-2006, if there was an in situ cancer followed by an invasive cancer at the same site and histology, only the invasive primary was retained, the date of diagnosis was linked to the invasive primary. The Canadian Cancer Registry multiple primary rules did not allow an in situ and invasive primary to be retained for the same site and histology.

Carcinoma In Situ of the Cervix, CIN, and the Bethesda System

The term “pre-invasive cervical neoplasia” refers to carcinoma in situ of the cervix and conditions viewed as equivalent to it or on a continuum with it. Diagnostic terminology for pre-invasive cervical neoplasia has changed significantly over time, from the four-tiered system of dysplasia and carcinoma in situ, to the three-tiered system of CIN, to the two-tiered Bethesda System, with high- and low-grade squamous intraepithelial lesions (SIL). In the past, cancer registries generally considered carcinoma in situ of the cervix reportable, but they differed in which of these other terms they considered synonymous with carcinoma in situ and hence reportable. Consequently, data were not comparable over time or across registries.

NAACCR convened a multidisciplinary working group in April 1993 to review the problem and make recommendations for its membership. The recommendation was that “population-based registries discontinue routine collection of data on pre-invasive cervical neoplasia unless there is strong local need and interest, and sufficient resources are available to collect all [high-grade squamous intraepithelial lesions] and its equivalent terms.”30 NAACCR and NPCR adopted this recommendation at that time. SEER and CoC adopted it effective for cases diagnosed January 1, 1996, forward. CCCR adopted it effective for cases diagnosed June 1, 2007.

Ambiguous Terminology

In most circumstances, the diagnosis of cancer, as recorded in the patient’s medical record, is clearly synonymous with reportable cancer. However, in those situations where the physician is not certain of the diagnosis, the associated terminology in the medical record reflects that uncertainty and is ambiguous. CoC, NPCR, SEER and CCCR are in agreement in regard to the list of terms that are diagnostic of cancer and the list of terms not diagnostic of cancer. These terms are shown in Table 2.

Table 2. NAACCR Version 21: Comparison of Reportable Cancers: CoC, SEER, NPCR and CCCR.

  CoC SEER NPCR CCCR

Reportable Diagnoses

1. Behavior code of 2 or 3 in ICD-O-3; or, for 2010 and later diagnoses, behavior code 3 according to the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2008)39.

2. Non-malignant (behavior codes 0 and 1) primary intracranial and central nervous system tumors, including juvenile astrocytoma (M9421/3)* for primary sites as defined in Table 3.

3. Carcinoid, NOS of the appendix C181 (as of 1/1/2015).


1. Behavior code of 2 or 3 in ICD-O-3.2; or, for 2010 and later diagnoses, behavior code 3 according to the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2008)39.

2. Non-malignant (behavior codes 0 and 1) primary intracranial and central nervous system tumors, including juvenile astrocytoma (M9421/3)* for primary sites as defined in Table 3.

3. As of 01/01/2021, early or evolving melanoma in situ, or any other early or evolving melanoma, is reportable.

4. Carcinoid, NOS of the appendix C181 (as of 1/1/2015).

5. All GIST tumors are reportable as of 01/01/2021. The behavior code is /3 in ICD-O-3.2.

6. Nearly all thymomas are reportable as of 01/01/2021. The behavior code is /3 in ICD-O-3.2. The exceptions are microscopic thymoma or thymoma benign (8580/0), micronodular thymoma with lymphoid stroma (8580/1), and ectopic hamartomatous thymoma (8587/0).

7. Lobular neoplasia grade III (LN III)/lobular intraepithelial neoplasia grade III (LIN III) breast C500-C509 (as of 1/1/2016).

8. Pancreatic intraepithelial neoplasia (PanIN III) (as of 1/1/2016).

9. Penile intraepithelial neoplasia III (PeIN III) (as of 1/1/2016).
1. Behavior code of 2 or 3 in ICD-O-3 (includes VIN III, VAIN III, AIN III); or, for 2010 and later diagnoses, behavior code 3 according to the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2008)39.

2. Non-malignant (behavior codes 0 and 1) primary intracranial and central nervous system tumors, including juvenile astrocytoma (M9421/3)* for primary sites as defined in Table 3.

3. As of 01/01/2021, early or evolving melanoma in situ, or any other early or evolving melanoma, is reportable.

4. Carcinoid, NOS of the appendix C181 (as of 1/1/2015).

5. All GIST tumors are reportable as of 01/01/2021. The behavior code is /3 in ICD-O-3.2.

6. Nearly all thymomas are reportable as of 01/01/2021. The behavior code is /3 in ICD-O-3.2. The exceptions are microscopic thymoma or thymoma benign (8580/0), micronodular thymoma with lymphoid stroma (8580/1), and ectopic hamartomatous thymoma (8587/0).
1. Behavior code of 2 or 3 in ICD-O-3; or, for 2010 and later diagnoses, behavior code 3 according to the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2008)39.

2. Benign (behaviour code of 0 in ICD-O-3) intracranial and central nervous system tumors (ICD-O-3 topography codes C70-C72) (1/1/1992).

3. Benign (behaviour code of 0 in ICD-O-3) endocrine glands and related structures (ICD-O-3 Topography codes C75.1-C75.3) (1/1/2007).

4. Borderline (behavior code 1) malignancies (all topographies in ICD-O-3) (1/1/1992).

5. Carcinoid, NOS of the appendix C181 (as of 1/1/2012).

6. Non-invasive follicular thyroid neoplasm with papillary-like nuclear features, NIFTP (1/1/2017).

7. Non-invasive EFVPTC C739 (1/1/2017).

8. Non-invasive encapsulated follicular variant of papillary thyroid carcinoma EFVPTC C739 (1/1/2017).

9. Non-invasive FTP C739 (1/1/2017).


Exceptions
(not reportable)

1. Skin cancers (C44._) with histology 8000-8110 (after 1/1/2003); prior to that date, AJCC stage groups 2-4 in this group were reportable.

2. CIS of the cervix and CIN III or SIN III (after 1/1/96).

3. PIN III (after 1/1/96).

4. VIN III (after 1/1/96).

5. VAIN III (after 1/1/96).

6. AIN (after 1/1/96).
1. Skin cancers (C44._) with histologies 8000-8005, 8010-8046, 8050-8084, 8090-8110.

2. CIS of the cervix and CIN III or SIN III of cervix (after 1/1/96).

3. PIN III (after 1/1/2001).
1. Skin cancers (C44._) with histologies 8000-8005, 8010-8046, 8050-8084, 8090-8110.

2. CIS of the cervix and CIN III or SIN III.

3. PIN III (after 1/1/2001).
1. Skin cancers (C44._) with histologies 8050-8084, 8090-8110 (1/1/1992).

2. Skin cancers (C44._) with histologies 8000-8005, 8010-8046 (1/1/2007).

3. In situ (behaviour code of 2 in ICD-O-3) of the cervix including CIN III (1/1/2007).

4. In situ (behaviour code of 2 in ICD-O-3) including PIN III of the prostate (1/1/2007).

5. In situ (behaviour code of 2 in ICD-O-3) of the colon and rectum with histology 8148 (1/1/2019).

Multiple Primary Rules

2007 Multiple Primary and Histology Coding Rules (most recent version).

2018 Solid Tumor Coding Rules

2007 Multiple Primary and Histology Coding Rules (most recent version).

2018 Solid Tumor Coding Rules

2007 Multiple Primary and Histology Coding Rules (most recent version).

2018 Solid Tumor Coding Rules

2007 Multiple Primary and Histology Coding Rules (most recent version).

2018 Solid Tumor Coding Rules

Ambiguous Terminology  Diagnostic of Cancer**

apparent(ly)
appears
comparable with
compatible with
consistent with
favors
malignant appearing
most likely
presumed
probable
suspect(ed)
suspicious (for)
typical of

Exception: if the cytology is reported using any of these ambiguous terms and neither a positive biopsy nor a physician's clinical impression supports the cytology findings, do not consider as diagnostic of cancer.
apparent(ly)
appears
comparable with
compatible with
consistent with
favors
malignant appearing
most likely
presumed
probable
suspect(ed)
suspicious (for)
typical of

Exception: if the cytology diagnosis is reported using any of these ambiguous terms and neither a positive biopsy nor a physician's clinical impression supports the cytology findings, do not report.
apparent(ly)
appears
comparable with
compatible with
consistent with
favors
malignant appearing
most likely
presumed
probable
suspect(ed)
suspicious (for)
typical of

Exception: if the cytology is reported using any of these ambiguous terms and neither a positive biopsy nor a physician's clinical impression supports the cytology findings, do not consider as diagnostic of cancer.
apparent(ly)
appears
comparable with
compatible with
consistent with
favors
malignant appearing
most likely
presumed
probable
suspect(ed)
suspicious (for)
typical of

Exception: if the cytology is reported using any of these ambiguous terms and neither a positive biopsy nor a physician's clinical impression supports the cytology findings, do not consider as diagnostic of cancer.

Ambiguous Terminology NOT Diagnostic of Cancer**

cannot be ruled out
equivocal
possible
potentially malignant
questionable
rule out
suggests
worrisome
Any ambiguous terms not on the reportable list are not reportable. cannot be ruled out
equivocal
possible
potentially malignant
questionable
rule out
suggests
worrisome
cannot be ruled out
equivocal
possible
potentially malignant
questionable
rule out
suggests
worrisome

* Juvenile astrocytomas should be reported as 9421/3.
** Do not substitute synonyms such as “supposed” for “presumed” or “equal” for “comparable.” Do not substitute “likely” for “most likely.” Use only the exact words on the list.

Table 3. Primary Site Codes for Non-Malignant Primary Intracranial and Central Nervous System Tumors (non-malignant primary intracranial and central nervous system tumors with a behavior code of 0 or 1 [benign/borderline] are reportable regardless of histologic type for these topography codes).

Topography
Codes Description
C70.0
C70.1
C70.9
Meninges
Cerebral Meninges
Spinal meninges
Meninges, NOS
C71.0
C71.1
C71.2
C71.3
C71.4
C71.5
C71.6
C71.7
C71.8
C71.9
Brain Cerebrum
Frontal lobe
Temporal lobe
Parietal lobe
Occipital lobe
Ventricle, NOS
Cerebellum, NOS
Brain stem
Overlapping lesion of brain
Brain, NOS
C72.0
C72.1
C72.2
C72.3
C72.4
C72.5
C72.8
C72.9
Spinal Cord, Cranial Nerves, and Other Parts of the Central Nervous System
Spinal cord
Cauda equina
Olfactory nerve
Optic nerve
Acoustic nerve
Cranial nerve, NOS
Overlapping lesion of brain and central nervous system
Nervous system, NOS
C75.1
C75.2
C75.3
Other Endocrine Glands and Related Structures
Pituitary gland
Craniopharyngeal duct
Pineal gland