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Mechanisms that Impact Cancer Risk after Bariatric Surgery (R21 Clinical Trial Not Allowed)
Jun 1, 2025, 14:09

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

The NCI’s R21 NOFO supports exploratory “proof-of-concept” studies to uncover how bariatric surgery alters cancer risk. Unlike R01 applications requiring extensive preliminary data, R21 projects must address novel feasibility questions—not yet described in literature—using preprints with DOIs if needed. Focus areas include changes in bile acids, microbiome, host signaling, or other surgery-specific factors that influence tumorigenesis.

Eligibility Criteria

  • Applicant Organizations:

    • U.S. higher education institutions (public/state or private)

    • Nonprofits (with or without 501(c)(3) status)

    • For-profit entities (including small businesses)

    • Local, state, and tribal governments

    • Federal agencies

    • Independent school districts, public housing authorities, faith-based/community organizations, regional organizations

    • Not eligible: Foreign organizations and non-domestic (non-U.S.) entities; foreign components of U.S. organizations are allowed.

  • PD/PI Requirements:

    • Any investigator with the expertise and resources to conduct feasibility/exploratory mechanistic research on bariatric surgery and cancer risk.

    • Preliminary data: Unpublished data are not allowed. Instead, cite preprints with a DOI or published findings. If you already have unpublished data, apply to PAR-25-043 (R01).

  • Application Types Allowed: New, Resubmission, Revision.

  • Clinical Trials: Not allowed.

  • Nonresponsive Applications:

    • Projects whose primary aim is epidemiologic (cancer incidence) without mechanistic assays in surgical subjects.

    • In vitro–only studies.

    • Studies lacking analysis of tissue or fluid samples from post-surgery animals or humans.

Funding Details

  • Mechanism: R21 Exploratory/Developmental Research Grant

  • Budget: Up to $275,000 in direct costs over two years (maximum $200,000 in any one year).

  • Project Period: Maximum of 2 years.

  • Scope:

    • Feasibility/exploratory work must address mechanistic endpoints—e.g., shifts in bile acid profiles, gut microbiome metabolites, or signaling pathways—before full R01–style investigations.

    • Animal models should develop cancer within 6 months (e.g., Kras-driven pancreatic models); human cohort studies are allowed only if samples from post-surgery subjects (who did or did not develop cancer) are available to probe mechanism.

    • “Mechanism” is defined as biological endpoints from animal or human specimens that link surgery to cancer outcome.

Deadline

  • Letter of Intent (Optional): January 16, 2025

  • Application Due Dates:

    • June 16, 2025 (by 5:00 PM)

    • October 16, 2025 (by 5:00 PM)

    • February 16, 2026 (by 5:00 PM)

    • June 16, 2026 (by 5:00 PM)

    • October 16, 2026 (by 5:00 PM)

    • February 16, 2027 (by 5:00 PM)

    • June 16, 2027 (by 5:00 PM)

    • October 16, 2027 (by 5:00 PM)

  • Expiration Date: January 8, 2028

Where to Go for Further Information

  • Full Announcement: Search FOA PAR-25-044 on Grants.gov or visit the NIH Guide for Grants and Contracts.

  • Companion R01 Opportunity: PAR-25-043 (if preliminary data exist).

  • Scientific/Research Contacts:

    • General & Bariatric Surgery Questions / Clinical Trials:

      Edward R. Sauter, M.D., Ph.D.

      Tel: 240-276-7657 Email: [email protected]

    • Basic Cancer Biology & Mechanism Questions:

      Philip Daschner, M.S.

      Tel: 240-276-6227 Email: [email protected]

  • Peer Review Contact: Check your eRA Commons account (~2 weeks after due date).

  • Grants Management Contact:

    Amy R. Bartosch

    Tel: 240-276-6375 Email: [email protected]