Cancer Protocol Templates
Please direct questions or comments regarding CAP Cancer Protocols to cancerprotocols@cap.org.
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Cancer Reporting and Biomarker Reporting Protocols
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CAP Cancer Protocol Usage Limitations, Copyright, and Terms of Use
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.
Current Release Updates
Published Date
On June 17, 2026, the College of American Pathologists (CAP) released updates to the CAP Cancer Protocols, with changes across 8 protocols. Key highlights include:
- Breast DCIS, Biopsy: WHO 6th Edition content and explanatory note updates, enhanced tumor site and architectural pattern reporting, expanded multi-select functionality for Histologic Type and Nuclear Grade, and addition of DCIS extent and Additional Lesion(s) reporting elements.
- Breast DCIS, Resection: WHO 6th Edition content and explanatory note updates, enhanced DCIS tumor site, extent, and architectural pattern reporting, expanded multi-select functionality for Histologic Type and Nuclear Grade, addition of Additional Lesion(s) reporting, and updates to Margin, Regional Lymph Node, Special Studies, and pTNM Classification sections.
- Post-Release Update: Version 4.5.0.1 was released on June 24, 2026 to correct a minor note error identified following the initial protocol release. No other protocol content was affected.
- Breast Invasive, Biopsy: WHO 6th Edition content and explanatory note updates, enhanced grading, expanded DCIS-related reporting elements, and addition of Additional Lesion(s) reporting, including updates to required/core biopsy reporting elements.
- Breast Invasive, Resection: WHO 6th Edition content and explanatory note updates, expanded tumor extent and treatment response reporting, addition of repeating Tumor Characteristic and Additional Lesion(s) sections, updates to Margin, Regional Lymph Node, Special Studies, and pTNM Classification sections, and refinements to required/core resection reporting elements.
- Kidney Protocols (Biopsy & Resection): Histologic feature modeling refinements, grading updates, and tumor size reporting simplification.
- Head & Neck- HPV-Associated Oropharynx: Minor pTNM Classification updates, including the addition of a pT not assigned response option, and refinement of Perineural Invasion response selections by removing redundant terminology.
- Head & Neck – Mucosal Melanoma: Update to procedure question.
All changes are outlined in the Summary of Revisions.
If you have questions or concerns, please email CancerProtocols@cap.org.
On April 1, 2026, the College of American Pathologists (CAP) released updates to the CAP Cancer Protocols, with changes across 11 protocols and retiring two protocols. Key highlights include:
- Head and Neck Protocol Restructuring: Retirement of the Pharynx and Major Salivary Gland protocols, replaced with several new site-specific protocols including HPV-Associated Oropharynx, HPV-Independent Oropharynx and Hypopharynx, Nasopharynx, Salivary Gland, and Mucosal Melanoma.
- AJCC Staging Updates: Implementation of AJCC Version 9 staging for select Head and Neck protocols, including HPV-Associated Oropharynx, Nasopharynx, and Salivary Gland.
- Reporting Element Updates: Addition of the Tumor Bed Margin Status section and expanded lymph node reporting elements in several Head and Neck protocols, with some elements moving from conditionally required to required (core).
- Head and Neck Biomarker Updates: Removal of certain HPV and HER2 interpretation questions, addition of defined HER2 scoring criteria and additional antibodies, and terminology updates related to SWI/SNF complex–deficient sinonasal carcinoma.
- Protocol Content and Terminology Improvements: Updates across several protocols including refined tumor site and histologic type questions, improved nodal terminology for SNOMED coding, and removal of select grading and perineural invasion elements.
- Merkel Cell Carcinoma Updates: WHO 5th edition content updates, addition of Locoregional Cutaneous Metastases as a required reporting element, and new optional biomarker-related questions including MCPyV status.
All changes are outlined in the Summary of Revisions.
If you have questions or concerns, please email CancerProtocols@cap.org.
On September 17, 2025, the College of American Pathologists (CAP) released updates to the CAP Cancer Protocols, with changes across 11 protocols. Key highlights include:
- Lung, Resection: Addition of a conditionally reported Size of Tumor in Centimeters (cm) question for in situ carcinomas
- Lung, Biomarker: Updates/Additions to PD-L1, BRAF, NTRK, NRG1, and Tumor Mutational Burden sections
- Colon & Rectum, Resection: Correction of display item note
- Ophthalmic Protocols (Retinoblastoma & Uveal Melanoma): Updates to pTNM Classification section and eCP-only metadata and explanatory notes updates
- Central Nervous System & Hematologic Protocols (3): eCP-only metadata and explanatory notes updates
- GYN Biomarker:
- All immunohistochemical tests made optional (previously required)
- HER2 In Situ Hybridization Testing Status added as a required element for reporting Equivocal (score 2+) protein overexpression in HER2 Status for Trastuzumab Use
- MLH1 Promoter Methylation Analysis Status added as a required element for reporting Loss of nuclear expression of MLH1 and PMS2 in Immunohistochemistry (IHC) Interpretation for Mismatch Repair (MMR) Proteins
- Other minor updates
- General IHC Quantitative Biomarkers: Addition of optional Cold Ischemic Time, Fixative, and Fixation Time, Membranous Staining Intensity questions, and added responses for reporting internal controls
All changes are outlined in the Summary of Revisions.
If you have questions or concerns, please email CancerProtocols@cap.org.
On June 18, 2025, the College of American Pathologists released updates to the CAP Cancer Protocols. The release has changes to 23 protocols. Highlights of the Q2 release includes:
- Gastrointestinal Protocols (8): Addition of Treatment Effect questions, Histologic Types, and Tumor Size questions to account for Multifocal Invasive Carcinoma with additional neoplasms.
- Pediatric Protocols (11): Updates to Accreditation Requirements Statement (requirement for biopsy protocols)*, reformatting of explanatory notes and references, and acceptable range metadata (eCP only).
- Kidney Resection: Update to Lymphatic and/or Vascular Invasion question.
- Bladder Biopsy: Update to the Muscularis Propria (detrusor muscle) question to include Present, negative for tumor and Present, involved by tumor answers.
- Pleural Mesothelioma: Update to Histologic Grade as required only for epithelioid mesothelioma.
- Breast Biomarker Reporting: Update to Test Method Questions for Conditional Reporting
All changes are outlined in the June 2025 Summary of Revisions under resources.
If you have questions or concerns, please email cancerprotocols@cap.org.
On March 19, 2025, the College of American Pathologists released updates to the CAP Cancer Protocols. The release has content changes to 9 protocols. Highlights of the Q1 release includes:
- New Cancer Protocols: Paraganglioma Pheochromocytoma and PitNET
- Breast Biomarker: Content and explanatory note updates to include modifications to ER testing, PgR and HER2 sections
- Wilms Resection: Added International Society of Pediatric Oncology (SIOP) staging elements in addition to minor modifications of Children’s Oncology Group (COG) staging elements
- Invasive Melanoma Resection & Biopsy: Removal of pT staging elements from Melanoma biopsy. Revision of Margins sections and updates to other content and explanatory notes in both the resection and biopsy protocols.
- Testis: Updated to accommodate partial orchiectomy specimens
All changes are outlined in the March 2025 Summary of Revisions.
If you have questions or concerns, please email cancerprotocols@cap.org.
On December 11, 2024, the College of American Pathologists released updates to the CAP Cancer Protocols. The release has content changes to 9 protocols. Highlights of the Q4 release includes:
- Cutaneous Head and Neck SCC: Updates to content and explanatory notes, including WHO Histologic Types. LVI question update from “Lymphovascular Invasion” to “Lymphatic and/or Vascular Invasion”
- Endometrium Uterus:
- UPDATED Cover Page Instructions: Recommended for primary resection specimen with no residual cancer (e.g., following neoadjuvant therapy and / or following cancer diagnosis on previous biopsy / curettage)
- Restored the FIGO 2009 Staging/2018 FIGO Cancer Report elements
- Extensive updates to the case summary and explanatory notes
- Pharynx: AJCC Version 9 updates to Nasopharynx pTNM Classifications, associated content, and explanatory notes
- Urethra, Resection & Biopsy: Tumor Extent update
- Gynecologic Biomarker: Updates to HER2 testing and addition of subclonal loss of MMR expression, subclonal abnormal p53 expression, PD-L1 and folate receptor testing.
- AJCC Version 9 updates to content and explanatory notes to: Diffuse Pleural Mesothelioma, Lung Resection, and Thymus
All changes are outlined in the December 2024 Summary of Revisions.
If you have questions or concerns, please email CancerProtocols@cap.org.
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.
Cancer Reporting and Biomarker Reporting Protocols
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Gynecologic
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Head and Neck
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Hematologic
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Opthalmic
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Pediatric
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Thorax
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Bone and Soft Tissue
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General
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Resources
Current and previous cancer reporting and biomarker reporting protocols can be downloaded using the links in the table below.
Request access to eCP Data Dictionary
Read the cancer protocol frequently asked questions
Download the definition of Synoptic Reporting With Examples
Integrate the Cancer Protocol & Biomarker Templates into your LIS workflow. Learn about our electronic Cancer Protocols
Download a compressed file containing all 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
CAP Cancer Protocol Usage Limitations, Copyright, and Terms of Use
© 2026 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.
All customized or derivative versions of CAP cancer protocols remain the property of the College of American Pathologists and may not be reproduced, distributed, shared, or incorporated into any artificial intelligence system, including but not limited to machine learning and data mining, without prior written authorization from the CAP.
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.