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

Frequently Asked Questions (FAQs): PAR-25-248 (NCI/NIH) PLCO Biorepository Research

1) What is PAR-25-248?

PAR-25-248 is a National Institutes of Health (NIH) funding announcement from the National Cancer Institute (NCI). It supports research that improves understanding of cancer causes (etiology) and accelerates progress in early detection biomarker science, specifically by using biospecimens from the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial Biorepository.

2) What is the central requirement to be in scope for this funding opportunity?

The proposed project must use biospecimens from the PLCO Screening Trial Biorepository and must clearly leverage what is distinctive about these specimens and how they were collected. Applications that do not include PLCO biospecimen use are considered out of scope and will not be funded under this announcement.

3) If an application uses no PLCO biospecimens, can it still be funded under PAR-25-248?

No. The announcement states that applications that do not include PLCO biospecimen use are out of scope and will not be funded under this FOA.

4) Why is the PLCO resource scientifically valuable for this program?

PLCO offers high-quality, prospectively collected, pre-diagnostic specimens with rich linked participant data. This combination supports stronger inferences about biological changes that happen before clinical detection and helps reduce certain biases that can occur with retrospective specimen collections.

5) What types of biospecimens are highlighted as available from the PLCO trial?

From the screened arm of PLCO, investigators can access serial blood samples collected before cancer diagnosis. From the control arm, the resource includes a one-time collection of buccal cells.

6) What does "serial pre-diagnostic blood samples" mean in the context of PLCO?

It refers to multiple blood samples collected over time from participants before they were diagnosed with cancer (if they were later diagnosed). This supports analyses of biological markers longitudinally (changes over time), rather than relying on a single timepoint.

7) What kinds of linked data can be paired with PLCO biospecimens?

The PLCO biospecimens can be paired with extensive associated data, including demographic characteristics, diet and lifestyle factors, smoking history, screening results, and clinical outcomes.

8) What research themes is this FOA intended to support?

The FOA is intentionally broad as to cancer research topics, as long as the work is grounded in PLCO biospecimen use and takes advantage of PLCO-specific strengths. It supports research aimed at understanding cancer etiology and advancing early detection biomarker science.

9) What are examples of "responsive" research areas under this announcement?

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.

10) What kinds of biomarkers or biological signals are explicitly mentioned as potential targets?

The opportunity description mentions evaluating circulating proteins, metabolites, lipids, inflammatory markers, immune signatures, or nucleic-acid based signals in pre-diagnostic blood, and relating those measures to later cancer development, screening findings, or clinical endpoints.

11) How does the PLCO design help with risk modeling and study rigor?

Because PLCO includes prospectively collected pre-diagnostic samples and detailed covariate information, it can support rigorous risk modeling, help minimize certain biases common to retrospective specimen collections, and allow testing of whether candidate biomarkers can distinguish individuals who later develop cancer from those who do not.

12) Is this funding opportunity limited to a single cancer type?

No. The FOA is described as intentionally broad in the types of cancer research questions it will support, provided the project uses PLCO biospecimens and meaningfully capitalizes on PLCO-specific advantages.

13) What is the funding mechanism for PAR-25-248?

Funding is provided through a U01 cooperative agreement mechanism.

14) What does a U01 cooperative agreement imply for the relationship with NIH?

A cooperative agreement generally involves a more active partnership with NIH than a standard research grant. The specific details depend on the award terms, but the description notes substantial programmatic engagement such as coordination on study conduct, resource use, data standards, or sharing expectations.

15) Are clinical trials allowed under this FOA?

No. The FOA is designated "Clinical Trial Not Allowed." The supported work should not propose a prospective interventional clinical trial.

16) What types of studies are appropriate given "Clinical Trial Not Allowed"?

The announcement is geared toward observational, laboratory, and analytics-driven studies that leverage existing PLCO resources, including biospecimens and linked participant data.

17) What does the FOA emphasize about study design beyond simply requesting specimens?

Applicants are expected not only to request PLCO specimens, but to design studies that meaningfully capitalize on PLCO-specific advantages such as serial pre-diagnostic blood draws, prospective collection, and the breadth of linked behavioral and clinical data.

18) Who is eligible to apply for PAR-25-248?

Eligibility is expansive. Eligible applicants include many domestic organization types and some non-domestic entities, including (as listed): state/county/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 (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.

19) Are non-U.S. (foreign) organizations eligible?

The eligibility description indicates that some non-domestic entities are eligible, including certain foreign organizations and regional organizations.

20) What is the CFDA number associated with this program?

The program is listed under CFDA 93.393.

21) What activity category is this program associated with?

The program falls within the education and health activity category.

22) What is the original closing date listed for this opportunity?

The posting lists an original closing date of October 8, 2027.

23) What type of funding is this described as?

The award is described as discretionary funding.

24) What makes a project a strong fit for this opportunity, based on the description?

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.

25) How should applicants connect biomarkers to outcomes using PLCO resources?

The description suggests assessing biomarker signals in pre-diagnostic blood and evaluating how those signals relate to later cancer development, screening findings, or clinical endpoints, while accounting for lifestyle and behavioral factors captured in PLCO.