Sunday, May 18, 2025
5/18/2025
Vanguard Study Administrative Supplement - Abstract This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA- 24-111. 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. Although these tests are commercially available, little is known about their feasibility, acceptability, and effectiveness across diverse settings and populations. To address this evidence gap, the National Cancer Institute (NCI) launched the Cancer Screening Research Network (CSRN) to evaluate emerging technologies for cancer screening. As an initial effort, the CSRN has collaboratively developed the Vanguard Study to assess the feasibility of conducting a randomized controlled trial to evaluate MCD tests for cancer screening, which includes developing and evaluating the ability to engage participation of underserved and under-resourced populations. In response to RFA-CA-23-020, Kaiser Permanente Northern California (KPNC) was selected as a CSRN ACCrual, Enrollment, and Screening Site (ACCESS) Hub to recruit and enroll 2,000 eligible participants between 45-75 years of age. The underlying KPNC population for the Vanguard Study includes large numbers of Asian, Black, and Hispanic 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 KPNC ACCESS Hub is well-suited to achieve the goals of the study. However, due to the evolving complexity of the Vanguard Study protocol and that tasks required for participant recruitment, enrollment, and care navigation are substantially greater than was originally anticipated, this application seeks supplementary funding to support the additional effort needed to achieve the target recruitment goals and ensure participant diversity across racial and ethnic groups. In addition, supplemental funding will support added personnel for effective navigation and timely completion of diagnostic workups after a positive MCD test. In close collaboration with the Vanguard Study Coordinating and Communication Center, Statistics and Data Management Center, other ACCESS Hubs, and the NCI, the KPNC ACCESS Hub will contribute to the rigorous evaluation of MCD tests across diverse populations.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).