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Request for Applications: The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Etiologic and Early Marker Studies (EEMS) Program

The PLCO EEMS Steering Committee is pleased to announce the following request for proposals. If you plan to use PLCO samples for your study, please submit a proposal by July 15, 2010.
 
What is PLCO?

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is a large randomized controlled trial evaluating screening programs for these cancers. The PLCO Biorepository contains approximately 2.7 million biologic specimens, including blood specimens collected from intervention participants during their six trial screening years and buccal cell specimens collected from control participants.
 
How can I access PLCO biospecimens and what is ‘EEMS’?

PLCO biospecimens are available to the entire scientific community. Access to the biospecimens is administered through The Etiologic and Early Marker Studies (EEMS) Program, a component of the PLCO Trial established to facilitate etiologic and early marker research using Trial collection biospecimens. EEMS reviews proposal applications twice a year in June and December. More details about PLCO EEMS are available on the PLCO website at http://plco.cancer.gov or at www.plcostars.com  (you can request an account if you do not already have one).
 
Does PLCO EEMS have tissue samples in addition to blood and buccal cell specimens?  
Recent additions to the PLCO Biorepository include tissue microarrays (TMAs) created from formalin-fixed and paraffin-embedded pathology tissues. TMAs are currently available for colon cancer, colorectal adenoma, ovarian cancer, and prostate cancer. Ideally, TMA slides should be cut close to the time of laboratory analysis to preserve antigenicity. To minimize material loss, PLCO seeks multiple proposal applications so that slides can be cut for multiple projects at once. For additional information regarding the PLCO study, PLCO biospecimens, and TMAs, please log-in to the PLCO STaRS website at www.plcostars.com.
 
Is funding provided?

PLCO biospecimens and associated data are provided upon approval of the proposal application. However, funding is not provided via the PLCO EEMS review process.
 
What is the PLCO EEMS application process?

Proposals will be accepted for the PLCO EEMS Summer review cycle between June 1, 2010 and July 15, 2010.  Applications will be accepted until July 15, 2010.  

The EEMS application materials (the EEMS application forms, instructions, NIH biosketch template, confidentiality disclosure agreement (CDA), and the EEMS policy document), as well as general information regarding the EEMS review process can be found on the PLCO STARS home page. Individuals who do not already have access to PLCO STARS can self register by clicking the Login button located on the upper right corner of the page.  If you have any questions about registration, or the PLCO STARS website you should contact the PAR PLCO Helpdesk at parplcohelpdesk@westat.com or 240-314-2313.
 
Once your proposal is received, the EEMS Coordinating Center (Westat) will verify that all components are completed and forward the completed proposal packet to the EEMS Principal Investigators, the PLCO Project Officer and Chief Statistician for an initial suitability review. This initial review will be completed by early August 2010; applicants will then be notified of the results of the suitability review. The EEMS Review Panel will then review and provide comments on all suitable proposals based on the study’s significance, approach, innovation, compliance to PLCO priorities and policies, proposed statistical approach, proposed laboratory assays and the qualifications of the investigation team. It is anticipated that this review will be completed by mid-September 2010, contingent upon the quantity of proposals received.  The EEMS PIs and the PLCO PO will then make the final decision regarding all acceptable proposals based on input from the EEMS Review Panel.
 
EEMS proposals and additional materials must be submitted electronically through the online application form found on the PLCO STaRS web site.
 
Confidentiality Agreements (CDA) should be sent to the following address:
Kevin Brand, JD
Technology Transfer Specialist
Technology Transfer Branch
6120 Executive Blvd., Suite 450
Rockville, MD 20852
Phone: (301) 451-4566
Fax: (301) 402-2117
Email: brandk@mail.nih.gov
 
What happens after my proposal is approved?

If your proposal is approved, you will have up to three years from the date of approval to request the shipment of samples and commence activities on your study; please note that an IRB approval letter, as well as an executed PLCO EEMS Material Transfer Agreement (MTA) will be required in most cases prior to the release of samples.  If you are unable to request shipment of samples within this time frame due to lack of funding or other issues, please inform us. Otherwise, your application will be considered withdrawn and these samples will be released, allowing for other investigators to submit proposals to use them. Similarly, you will be required to re-apply should you still wish to use these samples. Additionally, once you receive samples, you have two years to submit laboratory analysis results to IMS.
 
If you have any questions please do not hesitate to contact us (plco-eems@westat.com or 240-314-5896).  Thank you for your time and we wish you success in your PLCO related studies.