NIH/NCI – Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed)

September 21, 2018 by School of Medicine Webmaster

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 participants in the PLCO screened arm, and a one-time collection of buccal cells from participants in the control arm. Tissue microarrays of formalin-fixed, paraffin-embedded (FFPE) tumor tissues are also available for a subset of the cases for selected cancers. This FOA supports a wide range of research including 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.


The PLCO, which was a randomized controlled cancer screening trial involving 155,000 participants from across the United States, was conducted to evaluate the effectiveness in reducing cancer-specific mortality of four screening programs: digital rectal examination and prostate specific antigen for prostate cancer; chest X-ray for lung cancer; flexible sigmoidoscopy for colorectal cancer; and the tumor marker CA125 in combination with transvaginal ultrasound for ovarian cancer. The main phase of the trial concluded in May 2012, and mortality outcomes have been published. PLCO participants are still being followed using a streamlined centralized approach in order to collect valuable data on cancer in the aging population. Information on trial design, screening protocols, publications, available types and numbers of biospecimens and associated data can be found on the PLCO website at

The PLCO Biorepository offers high quality, pre-diagnostic, serial blood samples (serum/plasma/DNA/red cells/cryo-preserved whole blood) ideal for investigation of the causes and the natural history of various cancers, and for pivotal validation of promising blood-based early detection biomarkers. The PLCO Biorepository has supported a wide range of research in cancer etiology and early detection. To date, 118 research projects using the PLCO biospecimens have been initiated, resulting in over 150 research publications. More information about on-going research projects and publications can be found on the PLCO website at

Research Scope

The purpose of this FOA is to stimulate areas of cancer research that require prospectively collected pre-diagnostic blood specimens available from the PLCO Biorepository. The proposed research project should not only involve use of PLCO biospecimens and data, but take advantage of their unique characteristics, in large part by focusing on research questions that cannot be adequately addressed by using clinical samples (samples collected following a diagnosis). In some cases, it may be necessary to include specimens from other sources in order to carry out the proposed research. In that case, the investigator should obtain approval from the other source to access the specimens and provide evidence of the approval.

Research projects that do not involve the use of PLCO biospecimens will not be supported under this FOA.

Some characteristics of the PLCO specimens and data include:

  • Pre-diagnostic serum/plasma/lymphocyte DNA samples collected months to years before cancer diagnosis;
  • Serial blood samples (which may include serum, plasma, and/or lymphocyte DNA) collected over a period of time up to 6 years;
  • Detailed demographic, dietary, lifestyle, and clinical data (all cancer incidence and all-cause mortality);
  • Average-risk population;
  • Tissue microarrays of FFPE tumor samples available for a subset of cases for breast, prostate, colorectal, lung, and ovarian cancers, with matching blood or DNA samples from the same person; and
  • Genotype data from Genome Wide Association Studies (GWAS) available on a subset of prostate, lung, bladder, pancreatic, and kidney cancers.

Detailed information about the PLCO Biorepository, including sample availability, can be found on the PLCO website at Given that any research project proposed for this FOA will be based on the use of PLCO specimens, interested investigators and applicants should first identify appropriate biospecimens and data by submitting a Specimen Verification Request Form on the PLCO website at Instructions on how to submit the Specimen Verification Request Form will be provided on the same website. The PLCO staff will check if the needed biospecimens and data are available. The applicant will be provided with a letter confirming the availability of the biospecimens within a short period of time. The applicant must include this letter in the application. If biospecimens from other resources are to be used, the investigator should provide a letter of approval from the other resource for accessing the required specimens.

Specific research areas of interest include, but are not limited to, the following:

  • Identifying biomarkers of various environmental, biochemical, and genetic risk factors of cancer;
  • Pivotal validation of early detection blood biomarkers in pre-diagnostic samples;
  • Developing early detection and/or risk prediction models based on longitudinal patterns of the biomarkers;
  • Identifying blood biomarkers that correlate with clinical behavior of the tumors, especially those that differentiate between aggressive and indolent cancers;
  • Correlating blood biomarkers to tissue biomarkers, histological and molecular subtypes, and clinical behaviors; and
  • Biomarker discovery in pre-diagnostic samples using high through-put, proven technologies.

Deadlines:  February 11, 2019; August 14, 2019; February 11, 2020; August 11, 2020; February 11, 2021; August 11, 2021 (letters of intent due 30 days prior to the deadline)


Filed Under: Funding Opportunities