NCI Cancer Screening Research Network: Coordinating and Communication Center

This application is being submitted in response to the NOSI identified as NOT-CA-24-111. The NCI-initiated Cancer Screening Research Network (CSRN) is a cooperative group developed to advance early detection research into population-level trials and related studies to evaluate novel approaches to cancer screening. The Vanguard trial is the first CSRN study and its primary objectives are 1) to determine the feasibility of a randomized controlled trial of two novel multicancer detection (MCD) assays and 2) to ensure equitable participation through recruiting and retaining diverse populations. Fred Hutchinson Cancer Center serves as the coordinating and communications center (CCC) for the Vanguard study and CSRN, providing scientific leadership, training, implementation support and monitoring for nine accrual and enrollment sites (“ACCESS Hubs”) located across the United States in diverse geographical, socioeconomic, and cultural communities. In year 1, the CCC has developed and supported the CSRN committee structure, led protocol development, initiated staff training and served as the primary point of contact for ACCESS Hubs. Through these interactions, the CCC has become aware of the larger number and greater diversity and complexity of the ACCESS Hubs and their recruitment plans to reach under-represented and underserved populations. Each ACCESS Hub will coordinate multiple recruitment sites, some concentrated in well-circumscribed urban areas and others dispersed regionally or even nationally. Some will recruit from a single, closed health system while others will use a combination of academic medical centers, private clinics and federally qualified health centers. An additional complexity of the Vanguard trial is in supporting diagnostic workflows for MCD tests, since neither the screening program sensitivity nor the accuracy of tissue of origin predictions are known and the facilities available and associated costs concerns vary considerably across sites. To meet the unanticipated demands of this first RCT of MCD assays in the US, we propose to: 1) Expand Community Advisory Board (CAB) participation; 2) Provide additional language translations of participant materials; 3) Provide additional recruitment and retention materials; 4) Increase training and monitoring resources; 5) Increase investigator time for committee work, engagement with Hubs, and implementation of a diagnostic review board.