Mechanisms that Impact Cancer Risk after Bariatric Surgery (R21 Clinical Trial Not Allowed)

The National Cancer Institute (NCI) invites applications for exploratory studies on how bariatric surgery affects cancer risk through mechanistic pathways, focusing on novel ideas and methods rather than established preliminary data. This R21 opportunity aims to support innovative, early-stage research that lacks existing feasibility studies or published preliminary data but has potential to uncover biological mechanisms that might explain cancer risk reduction associated with bariatric surgery. Research topics may include the role of elevated bile acids, the gut microbiome, and other metabolic changes associated with bariatric surgery. The ultimate goal is to understand the mechanisms underlying cancer risk modification after surgery, beyond the known effects on weight loss and metabolic health. This NOFO targets studies that focus on exploring the feasibility and development of innovative ideas rather than fully developed projects with substantial preliminary data. Applications are encouraged to leverage models such as bariatric surgery animal models, human biospecimens, or both to explore these mechanisms. Examples of relevant research questions include investigating changes in cancer biomarkers pre- and post-surgery, how different bariatric procedures affect cancer risk, and how factors such as gender and racial background influence outcomes. Proposals with interdisciplinary collaborations, especially those outside traditional cancer research fields, are particularly encouraged. Eligible applicants include higher education institutions, various levels of government, nonprofits, small businesses, and community-based organizations. International entities are not eligible as the primary applicant, although foreign components are allowed. Projects are expected to be completed within a two-year period, with a maximum budget of $275,000 in direct costs over the project period, and no more than $200,000 in any single year. The program does not allow clinical trials, focusing instead on basic or translational research involving animals or humans as observational studies. The application process includes strict adherence to the NIH’s Research (R) Instructions, and applicants must complete several pre-application registrations, including with the System for Award Management (SAM), eRA Commons, and Grants.gov. Key dates include an initial due date of February 16, 2025, for new submissions, with subsequent due dates for future submission cycles. Letters of intent are recommended but not required and should be submitted 30 days before the due date. Applications will be reviewed based on factors including the significance of the proposed work, scientific rigor, innovation, and the qualifications of the research team. Key review criteria are the potential impact of the research on the understanding of cancer risk mechanisms post-bariatric surgery, the rigor of the study design, and the feasibility of achieving the stated goals within the project period. Applications will go through NIH’s peer review process, with high-scoring applications advancing to a national advisory council review. The NCI encourages early discussions with program contacts to determine if proposals align with NOFO goals, especially for those considering interdisciplinary approaches. Contact information is provided for support in application preparation, submission, and program-specific questions. Selected projects will be expected to comply with the NIH data management and sharing policy, including progress reporting, and will receive a Notice of Award upon approval.