Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed) | PAR 25 248

Opportunity Information: Apply for PAR 25 248

This grant opportunity, PAR-25-248, is a National Institutes of Health (NIH) funding announcement from the National Cancer Institute that supports research aimed at improving understanding of cancer causes (etiology) and accelerating progress in early detection biomarker science. The central requirement is that proposed projects must use biospecimens from the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial Biorepository and must clearly leverage what is distinctive about these samples and the way they were collected. Applications that do not include PLCO biospecimen use are considered out of scope and will not be funded under this announcement.

The scientific appeal of PLCO for this program is the availability of high-quality, prospectively collected, pre-diagnostic specimens and rich linked participant data. From the screened arm of PLCO, investigators can access serial blood samples collected before cancer diagnosis, which is especially valuable for studying biological changes that occur prior to clinical detection and for evaluating markers over time rather than at a single snapshot. From the control arm, the resource includes a one-time collection of buccal cells. These biospecimens can be paired with extensive associated data, including demographic characteristics, diet and lifestyle factors, smoking history, screening results, and clinical outcomes. The combination of pre-diagnostic sampling and detailed covariate information makes PLCO particularly useful for rigorous risk modeling, minimizing certain biases common in retrospective specimen collections, and testing whether candidate biomarkers can distinguish people who will later develop cancer from those who will not.

The FOA is intentionally broad in the types of cancer research questions it will support, as long as the work is grounded in PLCO biospecimen use and takes advantage of the resource's unique strengths. Examples of responsive areas include biochemical, molecular, and genetic analyses related to cancer risk and susceptibility, as well as discovery and validation studies for biomarkers intended for early detection. In practical terms, this could include evaluating circulating proteins, metabolites, lipids, inflammatory markers, immune signatures, or nucleic-acid based signals in pre-diagnostic blood, and assessing how these signals relate to later cancer development, screening findings, or clinical endpoints, while accounting for lifestyle and behavioral factors captured in PLCO.

Funding is provided through a U01 cooperative agreement mechanism, meaning the award involves a more active partnership with NIH compared to a standard research grant. While the specific details of NIH involvement depend on the award's terms, cooperative agreements generally imply substantial programmatic engagement such as coordination on study conduct, resource use, data standards, or sharing expectations. The FOA is designated "Clinical Trial Not Allowed," so the supported work should not propose a prospective interventional clinical trial; instead, it is geared toward observational, laboratory, and analytics-driven studies leveraging existing PLCO resources.

Eligibility is expansive and includes many types of domestic organizations and some non-domestic entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) as well as small businesses; and additional categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, and certain foreign organizations and regional organizations. The program is listed under CFDA 93.393 and falls within the education and health activity category.

Key logistics from the posting include an original closing date of October 8, 2027, and the award is described as discretionary funding. The announcement emphasizes that applicants should not only request PLCO specimens, but also design studies that meaningfully capitalize on PLCO-specific advantages like serial pre-diagnostic blood draws, prospective collection, and the breadth of linked behavioral and clinical data. In short, the opportunity is best suited to teams proposing well-justified biomarker, molecular epidemiology, and risk-focused projects where PLCO samples are essential to the aims and where the prospective, pre-diagnostic nature of the resource directly strengthens the study's scientific conclusions.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393.
• This funding opportunity was created on 2024-11-21.
• Applicants must submit their applications by 2027-10-08.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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