Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The opportunity is titled "Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01)" and the Funding Opportunity Number is PAR 15 297.

Which agency is offering this opportunity?

This is a National Institutes of Health (NIH) program that leverages resources from the National Cancer Institute (NCI), specifically the PLCO Screening Trial biorepository.

What is the main purpose of the funding opportunity?

The central aim is to advance cancer research by making targeted use of the PLCO biorepository to (1) improve understanding of cancer causes (etiology) and (2) accelerate discovery and validation of biomarkers that could enable earlier detection.

Is use of PLCO biospecimens required?

Yes. A key condition is that the proposed project must use PLCO biospecimens and must be built around the specific strengths of the PLCO resource. Projects that do not incorporate PLCO biospecimens are explicitly not supported under this announcement.

What is the PLCO resource?

The PLCO resource refers to the biorepository from the NCI Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, including biospecimens and linked participant data collected through the trial.

What makes the PLCO biorepository scientifically valuable for this program?

The PLCO biorepository is valuable because of the types of specimens, the timing of collection (including samples collected before diagnosis), the availability of serial (repeated) samples, and the depth of linked participant data that supports epidemiologic and translational research.

What biospecimens are available from the screened arm of PLCO?

From participants in the screened arm, the repository includes high-quality blood samples collected prospectively and collected serially before diagnosis, enabling analysis of biological changes that occur prior to clinical cancer detection.

What biospecimens are available from the control arm of PLCO?

From participants in the control arm, the repository includes a one-time collection of buccal cells, which can be especially useful for genetic and genomic analyses.

What types of data are linked to the PLCO biospecimens?

Biospecimens are linked to rich participant data, including demographics, diet, lifestyle factors, smoking history, screening results, and clinical information. This combination strengthens epidemiologic and translational analyses.

What kinds of research are encouraged under this funding opportunity?

The scope is broad as long as it meaningfully leverages the PLCO collection. Encouraged research includes biochemical, molecular, and genetic studies that clarify cancer risk and mechanisms, as well as biomarker research spanning discovery through validation for early detection.

Does the program emphasize early detection biomarker work?

Yes. A major focus is accelerating discovery and validation of biomarkers that could enable earlier cancer detection, using the pre-diagnostic and often longitudinal nature of PLCO samples to test whether markers signal early disease rather than changes after cancer has emerged.

Why are pre-diagnostic and serial samples important for this opportunity?

Pre-diagnostic and serial samples allow investigators to study marker trajectories and biological changes in the months or years leading up to diagnosis, which can be difficult to assess in typical case-control collections.

What types of scientific questions can PLCO’s longitudinal samples help answer?

Examples mentioned include whether biomarker trajectories change before diagnosis, whether markers are associated with aggressive versus indolent disease, and how biomarkers perform when evaluated alongside real-world screening and clinical data.

Do applications need to demonstrate that they are using the specific strengths of PLCO?

Yes. The expectation is not only that applicants will use PLCO specimens, but that the study design will capitalize on the unique prospective and serial nature of the samples and the associated dataset.

What funding mechanism is used?

This opportunity uses a cooperative agreement mechanism (U01), described as a discretionary funding opportunity.

What does the U01 cooperative agreement imply about NIH involvement?

A U01 generally indicates that the funding agency expects substantial scientific or programmatic involvement during the project period compared with a standard research grant.

What is the CFDA number and program area associated with this funding?

The activity is associated with CFDA number 93.393, Cancer Cause and Prevention Research.

Is cost sharing or matching required?

No. Cost sharing or matching is not required for this opportunity.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. governmental entities (state, county, city/township, special district), tribal governments and tribal organizations, public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations.

Are specific institution designations and community-based organizations included in the eligibility list?

Yes. The eligibility language includes Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations, among others.

Are federal agencies, U.S. territories, regional organizations, and foreign organizations eligible?

Yes. The eligibility description extends to certain federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations).

When was the announcement posted, and what are the closing and archive dates?

The announcement was posted on July 14, 2015. The original and current closing date is August 15, 2018, and the archive date is September 15, 2018.

Where can applicants find the official funding opportunity announcement?

The full official announcement is available through the NIH grants guide at http://grants.nih.gov/grants/guide/pa-files/PAR-15-297.html.

Who should be contacted for technical access issues with the FOA link?

Technical access issues and problems linking to the funding announcement are directed to the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.