This is CAP protocol

1. foundation.cap.org
Introduction to the CAP Cancer Protocols
June 7, 2023
7:00 am (CDT)

2. Welcome

3. Our MISSION is to improve people’s health by:
• Developing tomorrow’s pathology leaders
through awards for advanced training,
research and education.
• Mobilizing pathologists to expand health
equity in medically underserved
communities within the US and globally.
Our VISION is to
• Support all pathologists to be leaders in their
communities and at the forefront of patient-
centered care.
Mission & Vision of the CAP Foundation

4. CAP Cancer Protocols
Joseph Khoury, MD, FCAP
University of Nebraska Medical Center
Stokes-Shackleford Professor and Chair,
Department of Pathology and Microbiology
Chair, CAP Cancer Committee

5. • Synoptic data entry tools aimed at improving the quality of
cancer reporting
• Clinically relevant evidence-based data elements drawn from
standard-setting sources (WHO and AJCC)
• Applicable to academic and non-academic pathology practices
• Partnerships on data harmonization
CAP Cancer Protocols

6. Structured Data Reporting
Pathology Report
Biomarker Data
Structured
Synoptic Data
CAP Cancer Committee
Tumor Registries
SEER
NCI
Decision Support
Cancer Care Team
AJCC
WHO
ASCO

7. Rigorous Content Optimization
CAP Cancer Committee
Expert Panel
Resource Cmtes
House of Delegates
Public
Input
Structured
Synoptic Data

8. Breast Hematolymphoid GI
Pediatrics GU Head & Neck
Endocrine
Bone & Soft
Tissue
Skin
PERT
WHO
AJCC
NACCR
NCI/SEER
ASCO
- Community pathology
- Outbound liaisons
- ACS/CoC
- ICCR
- WHO
- PERT

9. • 98 CAP Cancer Protocols
• 89 electronic Cancer Checklist (eCC) Case Summaries
• 11 Biomarker Templates
• Utilized in pathology reporting by providing standard question and answer sets
• Explanatory Notes and References
• Compilation of standards
• AJCC
• WHO Blue Books
• FIGO
• Collaborative Staging
• CAP/ASCO Center Guidelines
• Inclusion of core data elements in pathology cancer reporting mandated for accreditation by ACoS-
CoC & CAP LAP (for resection specimens only)
• Quarterly scheduled releases
9
CAP Cancer Protocols

10. Development of Cancer Protocols
Uma Krishnamurti, MD,
PhD, FCAP
Yale University
Associate Professor, Department of
Pathology Director of Breast Pathology
Member, CAP Foundation Global Pathology
Workgroup
Member, CAP Cancer Committee

11. • The Cancer Committee has pathologists with subspecialty expertise
• Primary authors are responsible for the scientific content of the
protocols in a specific pathology subspecialty
• The authors work closely with the cancer committee staff members for
the final protocol output (Committee Advisor, Clinical Product Manager
& Clinical Quality Manager of Cancer Protocols and Data Standards)
CAP Cancer Committee

12. • Pathologists regularly review and update the protocol checklists
• Where required new protocols are created such as the
“Protocol for the Examination of Resection Specimens From Patients
with Phyllodes Tumor of the Breast” was first posted in March 2022
(designated as Version: 1.0.0.0)
CAP Cancer Committee

13. • On the website, the protocols are arranged by Organ systems.
• https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates
CAP Cancer Protocol Templates

14. CAP Cancer Protocol Templates

15. First page
of the
Cancer protocol
Major change, significant revision, moderate revision, minor revision

16. • Second page Accreditation requirements are given which entails
“Synoptic reporting”
“Synoptic reporting” is described in detail
• Third page gives the Summary of changes in the latest version of the
protocol
• Reporting template follows standards set by AJCC and WHO
• Explanatory notes for each reporting section

17. • Core data elements
• These are required in reports to adequately describe appropriate
malignancies.
• For accreditation purposes, core data elements must be reported in
all instances, even if the response is “not applicable” or “cannot be
determined.”
• Conditional data elements
• These are only required to be reported if applicable as delineated in
the protocol. For instance, the total number of lymph nodes examined
must be reported only if nodes are present in the specimen.
• Optional data elements are identified with “+” and although not required
for CAP accreditation purposes, they may be considered for reporting as
determined by local practice standards.
CAP Cancer Protocol Elements

18. • For uniformity and ease of use, for most anatomic sites the data elements
(DE) are in specific order with section headings that are capitalized.
• The main Cancer protocol template headings are:
• SPECIMEN (Type of surgical procedure performed on which the cancer
is being reported)
• TUMOR
• MARGINS
• REGIONAL LYMPH NODES
• DISTANT METASTASIS
• pTNM CLASSIFICATION (latest AJCC Edition)
• ADDITIONAL FINDINGS
• SPECIAL STUDIES
Order of Data Elements in the Cancer synoptic

19. • TUMOR
+ Tumor site
Histologic type
Histologic grade
Tumor size
+ Tumor focality
Ductal carcinoma in situ
Tumor extent
Lymphatic and / or Vascular Invasion
+Dermal Lymphatic and / or Vascular Invasion
+Microcalcifications
Treatment effect
Data Elements within a section heading for e.g., Invasive breast

20. Subheadings with a Core Heading maybe Core or optional
TUMOR
Lymphatic and / or Vascular Invasion (Note I)
___ Not identified
___ Present
+___ Focal (LVI in one block only)
+___ Extensive (LVI in two or more blocks)
___ Cannot be determined: _________________
Subheadings within a Core Data element

21. Wherever needed clarifying text is given to guide pathologist in filling the data
element. In addition, pathologist can refer to the appropriate explanatory notes
Notes within the reporting section

22. Custom Web based tool to help streamline
process for review and rollout of Cancer and
electronic Cancer Protocols (eCP)
Allows for authors to edit, collaborate, save,
and produce the CAP Cancer Protocols
within a web-based tool
Both CAP Cancer Protocols and eCP will be
created from a single database, thus
removing the issue of discrepancies between
the paper protocols and eCP
Single Source Product (SSP)
Author Draft to Data Entry by End-User

23. 31 May 2023
CAP Cancer Protocol Release Process

24. • To test the electronic version, several mock cases are entered and
tested in an electronic platform (mTuitive) to ensure that all data
elements (core, conditional, and optional) function as expected and
that the TNM category output is accurate.
• Cancer Protocols & Data Standards team publishes protocol to the CAP
website and licensed eCP users
• Pathologist users can reach out anytime to the CAP and/or protocol
authors with comments and questions related to the protocol.
Steps before releasing a cancer protocol

25. Authoring, modeling, and QA takes up a lot of time.
• Primary author spends at least ~20 hours making major
revisions on an existing protocol and working with CAP staff to
go over modeling and editing metadata for electronic versions
of the protocol
• The CAP staff spends about 160-180 man-hours per protocol
for major revisions and 270-300 man-hours for a new protocol.
Steps before releasing a cancer protocol

26. Value of the Cancer Protocols
Lara R. Harik, MD, FCAP
Associate Professor, Emory University
School of Medicine
Medical Director, Clinical Laboratories
Hospital Service Line
Vice Chair, CAP Cancer Committee
Member, CAP Foundation Global
Pathology Workgroup

27. Value
Free resource
Follow standards by WHO/
AJCC
Standardization of Reporting
Explanatory notes

28. 1. Free Resource

30. • World Health Organization (WHO)
• American Joint Committee on Cancer Staging
* Cancer Protocols are updated following updates of WHO or AJCC
2. Our Guiding Standards

31. Cancer Protocols ensure
standard patient care reporting
• Resection Specimens
• Elements extracted from gross and microscopic H&E
• Core elements are mandatory and clinically important
• They are NOT research elements
3. Standardization of Information

32. • Type of resection
• Histologic subtype
• Tumor Grade
• Tumor extent
• Margins
• Lymph nodes
• pTNM staging
Diagnostic
Prognostic
Therapeutic
3. Standardization of information:
Core elements (mandatory)

33. Breast Carcinoma

34. Prostatic Carcinoma

35. Prostatic Carcinoma

36. 4.
Explanatory
Notes

37. 4. Explanatory Notes

38. Value
Free resource
Follow standards by WHO/
AJCC
Standardization of reporting
Explanatory notes

39. Follow the latest WHO and AJCC updates
Ensure consistent reporting
Prevent omission of clinically relevant data
Cancer Protocols

40. Questions?

41. email: capfndnwebinars@cap.org