Enhancing Cancer Surveillance in Colorado: Statewide Biomarker Collection

Colorado's comprehensive cancer programs are focusing on enhancing cancer surveillance by collecting biomarkers and prognostic factors statewide. The initiative involves multi-phase implementation, bidirectional reporting for genetic counseling services, and increasing testing for targeted therapies. The project aims to document prognostic factors for cancer cases in 2018 and utilize various data sources for information exchange and analysis.

• Cancer Surveillance
• Biomarkers
• Prognostic Factors
• Colorado Program
• Genetic Counseling

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1. Enhancing Cancer Surveillance: Statewide Collection of Biomarkers and Prognostic Factors, Colorado s Multi-phase Implementation Authors: Kieu Vu, John Arend, Nichole Cadez, Deb Darnell, Valerie Somma, Randi Rycroft, Loria Pollack, Paran Pordell

2. The Colorado Cancer Plan & Comprehensive Cancer Program Cancer Genomics Program -Bidirectional reporting for genetic counseling services - Advisory Committee CCCR Biomarker Project - Increase testing among individuals whose cancer treatment may benefit from targeted proven or emerging therapies -Uptake of universal testing Women s Wellness Connection - BCCP (Triple negative breast cancer) - WISEWOMAN & CRC

3. CCCR Biomarker Project Colorado Law and Board of Health regulation allow flexibility for the CCCR to add new requirements & ability to access CORHIO/RMCC Phase 1: review and case finding, create code sets, CO pages, 2018 documentation Phase 2: 2019 coding

4. Colorado Requirement: Prognostic Factors for 2018 Cases Document results of prognostic factors and/or biomarkers for the following tests in the Lab Text fields in the abstract unless otherwise noted. You will often find the results in the synoptic section of the pathology report. Document: Date of test, Lab where test was done, Test name and Results Note: If test is not done, state not done Prognostic Factors/ BioMarkers Notes (number cases reviewed) Site BRAF (Not yet reviewed code set already available) Colo/ Rectal MSI MSI ALK EGFR Record in SSDI # 3890; (n=XXXX) See MSI page (N=715) (N=661) (N=661) Colo/ Rectal Endometrium Lung - AJCC Stage 3B & 4 Record value % as noted, any value > 1% is positive (N=661) (N=661) PD-L1* ROS1 Translocation Clark's Level Document in Path text (Not yet reviewed) Melanoma (Invasive Only) Microsatellitosis BRAF BRAF Document in Path text (Not yet reviewed) (Not yet reviewed) (N=764) Thyroid * No CAP definitions available at this time For information on how results are presented, click on the following link to access the CAP templates: CAP Cancer Protocol Templates --Scroll down to access the Biomarker Templates

5. Biomarker Data Sources Health Exchange Database [CORHIO] Hospitals Each hospital has their individual software Colorado Central Cancer Registry RMCDS software Free Standing Cancer Centers or Physician Offices [Rocky Mountain Cancer Centers] Pathology Labs eMaRC

6. CCCR codes using CAP/ SSDI/ NCCN CCCR Code set CAP SSDI

7. MSI - colorectal, endometrium BIOMARKERS BRAF - colorectal, melanoma, thyroid ALK, EGFR, PD-L1, ROS1 -- late stage lung

8. Examples of data from electronic exchange and hospital

9. Biomarker data capture in the CCCRs RMCDS

10. Preliminary Results for Lung Cancer Biomarkers INSERT

11. Preliminary Results for Thyroid Cancer Biomarkers Thyroid BRAF 600 570 500 INSERT 400 300 200 149 100 29 6 5 3 1 0 Need review Normal, no mutation Postive for mutation p.V600E NA, no info Test not documented code 94 ???

12. Preliminary MSI results for CRC and Endometrium Colo-rectal and Endometrium MSI Biomarker 800 700 600 500 400 300 200 100 0 Need review MSI Stable MSI Unstable low MSI Unstable high MSI Unstable, NOS MSI Not MSI Test ordered, results not in chart MSI test not done, test not ordered, and test not performed MSI Not documented, indeterminate applicable, info not collected Colo/Rectal Endometrium

13. Challenges/Lessons learned Learning curve on NCCN guidelines/CAP protocols Insufficient detail on certain biomarkers (thyroid BRAF V600) 2018 delay Infrastructure OIT challenges eMaRC access RMCDS Biomarkers/Prognostic Factors are available and it is feasible to collect population-based biomarker data.

14. NEXT STEPS Complete data collection Train hospital registrars Develop report cards Pilot report cards with hospitals

15. Next Steps & Overall Process and Goals Choose Biomarkers Develop report cards Complete data collection Design code sets Pilot report cards with hospitals Train hospital registrars Create codes in software CO Biomarker Requirements Central registries can collect biomarker data on population level Monitor uptake of Universal testing Can the data improve clinical care? Data will improve ability to assign genetic risk Monitor appropriate use of testing

17. Thank you Questions and Contacts Kieu Vu kieu.vu@state.co.us 303.692.3475 John Arend john.arend@state.co.us 303.692.2542