This funding opportunity, titled Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed) (Funding Opportunity Number PAR-25-248), is offered by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The initiative aims to support research that leverages the unique resources of the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Biorepository to advance understanding of cancer etiology and develop biomarkers for early detection. The PLCO biorepository includes high-quality, prospectively collected pre-diagnostic blood samples, buccal cells, and clinical data, making it a valuable tool for groundbreaking research in cancer and age-related diseases.

The purpose of this opportunity is to reduce cancer risk, morbidity, and mortality through rigorous research that bridges knowledge gaps in cancer development and early detection. Funded projects must utilize PLCO biospecimens and data, emphasizing the unique pre-diagnostic nature of these resources. Research scope includes identifying and validating cancer biomarkers, developing risk prediction models, correlating blood biomarkers to tissue pathology, and investigating biomarkers related to aging and non-cancer outcomes. Studies focused on non-cancer outcomes are encouraged but must also utilize PLCO specimens. Non-compliant projects, such as those without PLCO biospecimen involvement, will not be reviewed.

Funding under this announcement is provided through cooperative agreements, with no specific budget limits other than alignment with project needs. The project period may extend up to five years. Eligible applicants include a wide range of U.S. and international entities, such as higher education institutions, nonprofits, small businesses, and government agencies. Prospective applicants must confirm the availability of PLCO biospecimens through a Specimen Verification Request Form and include a support letter with their application.

Applications must adhere to NIH policies, including data sharing and rigor in research design. Specific submission requirements include justifying the use of pre-diagnostic samples, detailing the time interval between sample collection and cancer diagnosis, and providing evidence of assay reproducibility for proposed biomarkers. Applications involving external biospecimens must include letters of approval for access. NIH will evaluate applications based on significance, rigor, feasibility, investigator expertise, and alignment with PLCO resource capabilities.

Key dates include an initial submission opening on January 10, 2025, with multiple application due dates through October 2027. Letters of intent are due 30 days before each submission deadline. Applications will undergo peer review, with funding decisions based on scientific merit, alignment with program priorities, and availability of funds. The earliest start date for initial funding is December 2025.

For additional guidance, applicants may contact scientific or administrative NIH staff listed in the announcement. Comprehensive details, including submission guidelines and data management expectations, are available in the full text of the Notice of Funding Opportunity.