The application period for investigators interested in obtaining biospecimens and data from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial re-opened June 1. A separate application for obtaining biospecimens and data with research funding is also open.
PLCO is a large randomized controlled trial evaluating screening programs for the prostate, lung, colorectal and ovarian cancers. The PLCO Biorepository contains approximately 2.7 million biologic specimens, including blood specimens collected from intervention arm participants during their six trial screening years and buccal cell specimens collected from control arm participants.
Recent additions to the PLCO Biorepository include tissue microarrays (TMAs) and free-standing tissue cores created from formalin-fixed paraffin-embedded pathology tissues. Tissue specimens are currently available for colorectal cancer, colorectal adenoma, ovarian cancer, prostate cancer, breast cancer (female and male), lung cancer and bladder cancer.
Access to the biospecimens is administered through two programs, the PLCO Etiologic and Early Marker Studies (EEMS) program, and a separate funding announcement (PAR-15-297). PLCO biospecimens are available to the entire scientific community.
EEMS, a component of the PLCO trial, was established to facilitate etiologic and early marker research using the biospecimens. The PLCO EEMS program accepts proposal applications twice a year in the summer and in the winter. Details about available biospecimens and completing the application process are available on the PLCO CDAS website.
Applications must be submitted online during the EEMS open review cycles. A preliminary application is required before a full application can be completed and submitted. The purpose of the preliminary application is to make sure that the requested biospecimens and data are available. Once a preliminary application is approved, the applicant will be notified and will be able to continue to submit a full application. Applicant will be notified of the outcome of the preliminary application review within 3 weeks of the submission.
Deadlines for the upcoming opportunities are:
EEMS preliminary application - June 1, 2016 to July 1, 2016
EEMS full application – July 2, 2016 to September 1, 2016
PLCO biospecimens and associated data are provided upon approval of the EEMS application, but funding is not provided via the PLCO-EEMS review process.
Once a full application is submitted, the EEMS Coordinating Center will verify that all components are complete and then forward the application to the EEMS Steering Committee for an initial suitability review. This will be completed by mid-September 2016; applicants will be notified of the suitability review results. Suitable applications are forwarded to the full EEMS Review Panel for evaluation based on significance, approach, innovation, proposed statistical approach, proposed laboratory assays and the investigator team qualifications. This review is expected to be completed by October 2016, contingent on the quantity of applications received. The EEMS Steering Committee makes the final decision based on the review outcome of the EEMS Review Panel.
Once an application is approved, the applicant has up to 3 years from the approval date to request shipment of samples and commence activities on the study. An IRB approval letter and an executed PLCO EEMS Material Transfer Agreement (MTA) is required in most cases prior to release of samples. Researchers who are unable to request shipment of samples within this time frame due to lack of funding or other issues must inform the PLCO EEMS Coordinating Center. Otherwise, their application will be considered withdrawn and the samples will be released, allowing other investigators to submit an application to use them. Researchers will be required to re-apply if they still wish to use the samples. Additionally, once samples are received, researchers have 2 years to submit laboratory analysis results. Small changes to an approved EEMS study may be accepted by submitting an addendum.
The separate Funding Opportunity Announcement allows investigators to apply for funding and for the PLCO specimens at the same time by submitting a grant application in response to PAR-15-297 (see the detailed instructions on how to submit an application in the FOA.) The next application due date for this announcement is August 16, 2016 and additional due dates continue twice a year through August 15, 2018.
For more information, contact the PLCO-EEMS Coordinating Center at: email@example.com.