Cancer Protocol Templates

Laboratories across the country and around the world rely on the CAP to help them stay current with the latest evidence-based practices and maintain quality and proficiency among the entire pathology team.

The CAP Cancer Protocols provide guidelines for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care. These protocols incorporate the latest standards to help pathologists and laboratories keep abreast of the advances and updates in cancer reporting, including:

• The World Health Organization Classification of Tumors (Blue Books)
• The American Joint Committee on Cancer Staging Manual

Synoptic reporting using the CAP electronic Cancer Protocols (eCP) also helps laboratories and hospitals comply with requirements for organizations like the American College of Surgeons Commission on Cancer, the CAP Laboratory Accreditation Program, and more.

The CAP Biomarker Reporting Protocols are intended to provide reporting guidance for commonly ordered biomarkers and are not required for accreditation purposes.

Latest News and Resources

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On June 19, 2024, the College of American Pathologists released updates to the CAP Cancer Protocols. The release features content changes to 16 protocols.

Highlights of the Q2 updates include:

• Invasive Melanoma of The Skin: Excision, Re-Excision: pN Category staging correction and overall editing in conjunction with AJCC for improved clarity of classifications.
• Breast Invasive Resection: All individual Residual Cancer Burden (RCB) reporting parameters are now optional and explanatory note updated to clarify use of “y” prefix and gross sampling for RCB Score reporting
• Kidney Resection and Biopsy: WHO 5th edition update to content and explanatory notes
• Vulva Resection: Separated “Margin Status for Paget Disease” elements from the “Margin Status for Precursor Lesions of Squamous Cell Carcinoma” question and semantic change to pT3 and pN0(i+) staging terminology
• Bone & Soft Tissue Resection and Biopsy: Updates to content and explanatory notes, including WHO Histologic Types and addition of core and optional questions

All changes are outlined in the June 2024 Summary of Revisions.

If you have questions or concerns, please email cancerprotocols@cap.org.

• Read the cancer protocol frequently asked questions.
• Download the definition of Synoptic Reporting With Examples.
• Visit the cancer protocol resources webpage to read about current issues with units of measurements.
• Integrate the Cancer Protocol & Biomarker Templates into your LIS workflow. Learn about our electronic Cancer Protocols.
• Download a compressed file containing all of current CAP cancer protocols.
• Download the current summary of revisions.
• Download the summary of required elements.
• Provide your feedback about the CAP cancer protocols to cancerprotocols@cap.org.
• June 2021 news release.

Current and previous cancer reporting and biomarker reporting protocols can be downloaded using the links in the table below.

On December 13, 2023, the College of American Pathologists released updates to the CAP Cancer Protocols. The release featured two new protocols, as well as content changes to 11 protocols.

Highlights of the Q4 updates include:

• Two NEW melanoma protocols: Invasive Melanoma, Excision (v1.0.0.0) and Invasive Melanoma, Biopsy (v1.0.0.0)
• Two existing melanoma cancer protocols were retired: Melanoma, Biopsy (v4.3.1.0) and Melanoma, Excision (v4.3.0.2)
• Colon, Resection protocol was updated to remove transanal disk procedure and add submucosal invasion for pT1 tumors
• Colon Biopsy protocol was updated to include transanal disk procedure
• Six gastrointestinal NET cancer protocols updated to reflect WHO and AJCC content
• Two gynecologic cancer protocols updated to reflect AJCC and/or FIGO content

If you have questions or concerns, please email cancerprotocols@cap.org.

On September 20, 2023, the College of American Pathologists released updates to the CAP Cancer Protocols. The release featured three new protocols, as well as content changes to 30 protocols.

Highlights of this release include:

• Three new hematology cancer protocols including Precursor and Mature Lymphoid Malignancies, Myeloid and Mixed / Ambiguous Neoplasms, and Plasma Cell Malignancies. These new protocols reflect current WHO guidelines.
• Four existing hematology cancer protocols will be retired: Bone Marrow, Hodgkin Lymphoma, Non-Hodgkin Lymphoma and Plasma Cell.
• 12 pediatric protocols updated to reflect current WHO guidelines; these protocols will soon be required for CAP accreditation.
• 13 genitourinary protocols updated to reflect current WHO guidelines.
• Anus Local Excision updated to reflect AJCC version 9 content.

If you have questions or concerns, please email cancerprotocols@cap.org.

On June 21, 2023, the College of American Pathologists released updates to 6 CAP Cancer Protocols.

Highlights of this release include:

• Five Head and Neck Cancer Protocols were revised to reflect the WHO 5th Edition (Blue Books) including updates to Histologic Types, Grades, and Explanatory Notes.
• The Breast Invasive Resection protocol was revised to include conditional Residual Cancer Burden (RCB) reporting following neoadjuvant treatment.

If you have questions or concerns, please email cancerprotocols@cap.org.

The CAP released an accelerated update to the CAP Cancer Uterine Cervix Resection Protocol on April 5th, 2023. This update addresses an incorrect section header text for pTNM Classification to reflect use of AJCC 9th Version content.

The staging classifications themselves are not affected, as they were updated to the AJCC 9th Version in October 2020.

CAP Cancer Protocol users should refrain from using versions 5.1.0.0 and 4.003.001 of the CAP Cancer Protocol for Uterine Cervix Resection, as these versions are invalid.

All changes are outlined in the April 2023 Summary of Changes.

If you have questions or concerns, please email cancerprotocols@cap.org.

On March 22, 2023, the College of American Pathologists released updates to 10 CAP Cancer Protocols.

Highlights of content changes in this release include:

• Thyroid protocol updated to reflect current WHO guidelines
• Breast Biomarker and Breast Invasive Resection protocols now include notes for HER2neu Low Expression
• Breast Invasive Biopsy has been updated to reflect the size of largest invasive focus in the limited biopsy sample
• Gynecologic Biomarker has been updated to clarify content elements
• Ovary protocol includes content clarification, updates to TNM modifiers, LVI visible text, and contains critical information updated in explanatory notes
• Cervix Resection and Excision protocols also include content clarification, updates to LVI visible text, and TNM modifiers (Resection only)
• Stomach Resection has changes to Histologic Grade Requirements
• Adrenal Resection contains critical information updated in explanatory notes

All changes are outlined in the Summary of Revisions.

Cancer Reporting and Biomarker Reporting Protocols

Previous versions are available upon request at cancerprotocols@cap.org

Breast

Current Version
PDF (v4.4.0.0)
Word (v4.4.0.0)
June 2021

Central Nervous System

Endocrine

Gastrointestinal

Genitourinary

Gynecologic

Head and Neck

Hematologic

Ophthalmic

Pediatric

Skin

Thorax

Bone and Soft Tissue

General

CAP Cancer Protocol Usage Limitations and Copyright

© 2023 College of American Pathologists (CAP). All rights reserved.

The College of American Pathologists (CAP) does not permit reproduction of any substantial portion of these protocols without its written authorization. The CAP hereby authorizes use of these protocols by physicians and other health care providers in reporting on surgical specimens, in teaching, and in carrying out medical research for nonprofit purposes. This authorization does not extend to reproduction or other use of any substantial portion of these protocols for commercial purposes without the written consent of the CAP.

The CAP also authorizes physicians and other health care practitioners to make modified versions of the Protocols solely for their individual use in reporting on surgical specimens for individual patients, teaching, and carrying out medical research for non-profit purposes.

The CAP further authorizes the following uses by physicians and other health care practitioners, in reporting on surgical specimens for individual patients, in teaching, and in carrying out medical research for non-profit purposes: (1) Dictation from the original or modified protocols for the purposes of creating a text-based patient record on paper, or in a word processing document; (2) Copying from the original or modified protocols into a text-based patient record on paper, or in a word processing document; (3) The use of a computerized system for items (1) and (2), provided that the protocol data is stored intact as a single text-based document, and is not stored as multiple discrete data fields.

Other than uses (1), (2), and (3) above, the CAP does not authorize any use of the Protocols in electronic medical records systems, pathology informatics systems, cancer registry computer systems, computerized databases, mappings between coding works, or any computerized system without a written license from the CAP.

Any public dissemination of the original or modified protocols is prohibited without a written license from the CAP.

The Protocols include tumor staging data used with permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this information is the AJCC Cancer Staging System (2020).

The CAP developed these protocols as an educational tool to assist pathologists in the useful reporting of relevant information. It did not issue the protocols for use in litigation, reimbursement, or other contexts. Nevertheless, the CAP recognizes that the protocols might be used by hospitals, attorneys, payers, and others. Indeed, effective January 1, 2004, the Commission on Cancer of the American College of Surgeons mandated the use of the required data elements of the protocols as part of its Cancer Program Standards for Approved Cancer Programs. Therefore, it becomes even more important for pathologists to familiarize themselves with these documents. At the same time, the CAP cautions that use of the protocols other than for their intended educational purpose may involve additional considerations that are beyond the scope of this document.

The inclusion of a product name or service in a CAP publication should not be construed as an endorsement of such product or service, nor is failure to include the name of a product or service to be construed as disapproval.