Multi-Ethnic Multi-Cancer Early Detection and Screening (MED SCREEN) Study

Multi-cancer detection (MCD) tests, which evaluate cell-free DNA and other biological components with a single blood draw, are a new frontier in cancer screening, particularly for cancers with no effective screening methods. Despite commercial availability, little is known about their feasibility, acceptability, and effectiveness across diverse settings and populations. To address this evidence gap, the National Cancer Institute (NCI) is creating the Cancer Screening Research Network (CSRN) to conduct rigorous, multicenter cancer screening studies. In response to RFA-CA-23-020, we propose a CSRN ACCrual, Enrollment, and Screening Site (ACCESS) Hub that will recruit participants for the initial Vanguard study from Kaiser Permanente (KP) across 21 sociodemographically diverse medical centers in urban, suburban, and semi-rural areas of California that include ~1.45 million adults ages 45-70 years and that can efficiently expand, for follow-up CSRN studies, to 36 medical centers with ~3 million screening-eligible adults. Our underlying population for the Vanguard study includes large numbers of Asian or Pacific Islander (311,959), Black (100,910), and Hispanic (285,287) adults covered by Medicare, Medicaid, and commercial insurance, allowing for oversampling and inclusion of underrepresented groups. Efficiently linked by administrative and clinical data systems within an integrated health care system, the KP ACCESS Hub is well-suited to achieve the CSRN’s goals. Our setting provides comprehensive primary and specialty care with continuous longitudinal tracking of healthcare utilization, including standard of care cancer screening; has low loss to follow-up due to health plan disenrollment; and captures complete real-time information on patient encounters, referrals, diagnoses, procedures, test results, treatments, and outcomes in extensive electronic health record data systems, including laboratory, pathology, radiology, and cancer registry databases. The KP ACCESS Hub will be led by a multidisciplinary team embedded within KP clinical operations and research structures. The team has decades of clinical, scientific, and implementation expertise in cancer screening and proven experience with recruiting participants for large-volume trials, data management, and specimen collection, including the use of oversampling and other strategies for optimizing participant diversity and engagement. Drawing on these collective strengths, our specific aims are to: (1) Recruit, enroll, retain, and follow a sociodemographically diverse sample of 2,400 asymptomatic, average-risk adults ages 45-70 years, including understanding barriers to participation for underrepresented groups; (2) Develop and assess processes to effectively communicate MCD test results to participants and providers; (3) Identify and evaluate diagnostic pathways following a positive MCD test for timely follow-up care; and (4) Collect and transfer high-quality data and specimens from study recruitment through closeout for all needed endpoints. In close collaboration with the Coordinating and Communication Center, Statistics and Data Management Center, other ACCESS Hubs, and the NCI, the KP ACCESS Hub can inform the evaluation of MCD tests across diverse populations.