Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed) | PAR 18 913

Opportunity Information: Apply for PAR 18 913

This funding opportunity (PAR-18-913) is a National Institutes of Health, National Cancer Institute cooperative agreement (U01) that supports research projects aimed at improving understanding of cancer causes (etiology) and developing or strengthening biomarkers for early cancer detection. The central feature of the announcement is that funded studies must use biospecimens from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial biorepository, and they are expected to leverage what makes the PLCO collection distinctive rather than treating it as a generic sample source. Because it is labeled "Clinical Trial Not Allowed," the work should focus on observational and laboratory-based investigations (for example, biomarker discovery, validation, risk modeling, or mechanistic studies using existing specimens and data) rather than initiating an interventional clinical trial.

The PLCO biorepository is positioned as a major strength because it includes high-quality, prospectively collected specimens gathered before cancer diagnosis. In practical terms, this means investigators can evaluate markers that appear in blood or other biospecimens prior to clinical disease, which is particularly valuable for early detection and for reducing biases that occur when samples are taken after diagnosis or treatment. The resource includes serial, pre-diagnostic blood samples from participants in the screened arm of PLCO, allowing researchers to examine changes over time and assess whether biomarker trajectories predict future cancer. In addition, the control arm includes a one-time collection of buccal cells, which can support genetic and genomic studies. Alongside the specimens, the PLCO dataset provides rich contextual information such as demographics, diet, lifestyle factors, smoking history, screening results, and clinical outcomes. That combination enables integrated studies that connect molecular signals with exposures, behaviors, screening histories, and eventual cancer diagnoses.

The announcement emphasizes a broad range of allowable cancer research topics, as long as they are tightly linked to PLCO biospecimen use. Projects may include biochemical, molecular, and genetic analyses that clarify cancer risk, identify susceptibility factors, or investigate pathways tied to carcinogenesis. A major theme is early detection biomarker research, including both discovery and validation, with the advantage that the pre-diagnostic nature of the PLCO samples can help distinguish markers of early disease from markers that simply reflect late-stage illness, inflammation, or treatment effects. The expectation that applicants "take advantage of the unique characteristics" of PLCO suggests that proposals should be designed around features like the prospective design, serial sampling, long follow-up, screened-versus-control context, and the ability to link biomarker findings to detailed exposure and screening data.

A hard requirement is that the proposed research must involve PLCO biospecimens; applications that do not use PLCO samples are not eligible for support under this FOA. In other words, the PLCO biorepository is not optional or ancillary here, it is the core resource the program is built around. The cooperative agreement mechanism (U01) also implies a more collaborative relationship with NIH/NCI program staff compared to a standard investigator-initiated grant, typically involving coordination around resource use, data/specimen access plans, and alignment with program goals.

Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants listed include federal, state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and other tribal organizations. The opportunity also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) entities. The catalog number associated with the program is CFDA 93.393, and the opportunity was created on 2018-09-07, with an original closing date listed as 2021-08-11.

• 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 2018-09-07.
• Applicants must submit their applications by 2021-08-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for PAR 18 913

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