NOT-CA-24-111 Improving Strategies for Cancer Reduction through Early-detection and ENgagement (I-SCREEN)

This application is submitted in response to the NOSI identified as NOT-CA-24-111. The vision of this CSRN ACCESS Hub, Improving Strategies for Cancer Reduction through Early-detection and ENgagement (ISCREEN), is to leverage existing infrastructure and long-standing collaborations to conduct the Vanguard Study in diverse clinical settings and diverse populations through close collaborations with the NCI, the CSRN Coordinating and Communication Center (CCC), the Statistics and Data Management Center (SDMC), and the other ACCESS Hubs. I-SCREEN Hub has an exceptional opportunity to recruit under-represented populations to evaluate the two multi-cancer detection blood biomarker tests proposed for the Vanguard Study. We have selected and engaged health systems in I-SCREEN to include some populations defined by genetic ancestry (e.g., Hispanic/Latino, Asian, Native Hawaiian/Pacific Islander (NH/PI)), to include rural/frontier populations that disproportionately represent areas with high poverty and low levels of education, and to include populations with a spectrum of insurance coverage from uninsured to fully insured. Recruitment populations and sites in the ISCREEN Hub include two integrated care delivery systems (Kaiser Permanente Colorado [KPCO] and Kaiser Permanente Hawaii [KPHI]), one rural health system accepting >25 types of insurance (University Colorado Hospital-North [UCH-N]), and one rural critical access hospital system (Keefe Memorial Hospital and clinics [KMH]). Over the past year, the I-SCREEN Hub has worked with the NCI, the CSRN CCC, SDMC, and ACCESS Hubs, to develop procedures and protocols for the Vanguard Study. These new procedures and protocols differ substantially from the assumptions used in our original grant application and budget. To successfully execute the Vanguard Study and achieve our goal of recruiting and enrolling some of the most under-represented populations in clinical trials, we are requesting supplemental funding through this NOSI. Examples of the drivers for increased costs include: 1) increased staff time for each participant due to the increased complexity of consent consistent with the FDA’s Code of Federal Regulations 21 CFR, part 11 compliance which also restricts the use of anticipated electronic recruitment and consent systems; 2) more in-person/in-clinic recruitment and staff time for recruitment success due to the timelines and system specific requirements (e.g., OPEN, Medidata Rave) for participant enrollment and for randomization after the completion of the consent, baseline survey, and blood draw; and, 3) an increased number of diagnostic evaluations due to a higher predicted MCD test positivity percentage than originally anticipated. I-SCREEN supplemental funding will ensure the successful completion of year 2 of the Vanguard Study, will allow us to reach our target recruitment, and will support our goal to recruit and enroll some of the most under-represented populations in clinical trials.