Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for researchers seeking to access and analyze biospecimens from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. Eligible applicants include academic medical centers, research institutions, and nonprofit research organizations with 501(c)(3) status. The research must focus on cancer etiology, early detection, or prevention using existing PLCO biospecimens. Clinical trials are explicitly not allowed for this funding mechanism.
Applicants must demonstrate institutional capacity to conduct cancer research. Foreign institutions may participate but NIH collaboration requirements apply. The research must align with NIH priorities in cancer research and biospecimen-based investigations. No geographic restrictions apply beyond general NIH eligibility rules.
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Program description
This Funding Opportunity Announcement (FOA) encourages the submission of applications that propose to advance research in cancer etiology and early detection biomarkers, utilizing the advantages of the unique biorepository resources of the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. The PLCO Biorepository offers high-quality, prospectively collected, serial pre-diagnostic blood samples from the PLCO screened arm participants, and a onetime collection of buccal cells from the control arm participants. Available data associated with the biospecimens includes demographic, diet, lifestyle, smoking, screening results, and clinical data. This FOA supports a wide range of cancer research including, but not limited to, biochemical and genetic analyses of cancer risk, as well as discovery and validation of early detection biomarkers. The proposed research project must involve use of PLCO biospecimens; additionally, it should also take advantage of the unique characteristics of the PLCO biospecimens. Research projects that do not involve the use of PLCO biospecimens will not be supported under this FOA.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Cover Sheet
- Project Narrative (specific aims, background, methods)
- Detailed Budget and Budget Justification
- Biographical Sketches (PD/PI and key personnel)
- Letters of Support (PLCO program confirmation)
- Research Strategy (significance, innovation, approach)
- Vertebrate Animals or Human Subjects sections (if applicable)
- Institutional Support Letter
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.393 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$213,206,023
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$56,551,552
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$48,640,472
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$47,009,863
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$42,878,192
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$37,448,862
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$29,324,004
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$26,395,336
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$24,427,436
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$23,149,727
Top States by Funding
- MA 10 awards $374.4M
- CA 10 awards $260.1M
- MN 4 awards $106.9M
- NY 7 awards $99.9M
- TN 7 awards $97.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.393). How funding has trended year over year.
| 2024 | $754,945,159 | |
| 2025 | $834,514,512 | |
| 2026 est. | $520,096,276 |
FAQ
Who can apply for this grant?
Academic institutions, research hospitals, and nonprofit research organizations with 501(c)(3) status. Individual researchers must have institutional affiliation and appropriate credentials.
Are clinical trials allowed?
No. This program explicitly excludes clinical trial studies. Research must use existing biospecimens for observational or laboratory-based analysis.
What kind of research does NIH fund under this mechanism?
Cancer etiology studies, early detection biomarker research, and prevention-focused investigations using PLCO biospecimens. Mechanistic and translational research are supported.
How competitive is this funding?
Very competitive. NIH research grants typically fund 15-25% of applications. Strong preliminary data and experienced research teams improve success rates.
What funding levels should I expect?
U01 grants typically range from $350,000 to $500,000 annually, depending on research scope and institutional resources needed.
💡 Tips for applicants
- Demonstrate prior access to PLCO biospecimens or explain your access plan clearly. NIH reviewers expect detailed biospecimen use protocols.
- Focus your research question on cancer etiology or early detection gaps. Vague or broad applications score lower during review.
- Include letters of support from PLCO program managers confirming biospecimen availability for your proposed research.
- Provide strong preliminary data showing feasibility. New research areas need convincing proof-of-concept results.
- Address statistical power and sample size calculations explicitly. Reviewers scrutinize whether PLCO biospecimens are adequate for your aims.
⚠️ Common mistakes
Proposing clinical trial activities or patient intervention studies. This mechanism funds research use of existing biospecimens only. Failing to secure PLCO biospecimen access confirmation before submission. NIH expects evidence that materials are available and feasible to obtain. Submitting vague cancer research without clear etiology or early detection focus. Applications must address specific gaps in cancer understanding or detection.
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