PCPT and SELECT External Translational Medicine Proposal and Application Process

PCPT_SELECT

Prostate Cancer Prevention Trial (PCPT) and Selenium and Vitamin E Cancer Prevention Trial (SELECT) were two large prostate cancer prevention trials conducted by SWOG.  A large biorepository of samples from PCPT and SELECT trial participants, which includes men who developed prostate as well as lung, colon, and other cancers, is now available for cancer researchers as well as other researchers interested in a population of generally healthy men for whom we have long-term follow-up.

More information about the PCPT and SELECT biospecimens and their associated data elements is available from: SELECT Biorepository and PCPT Biorepository.

SWOG Policy 39: Acquisition, Maintenance and Use in Research of Tissue and Other Biologic Patient Specimens is designed to ensure compliance with current NCI guidelines for specimen banking from cooperative groups while making SWOG specimens available to a broader research base. The goal of this process is to obtain a commitment for the use of available materials.

Specimen Availability

Biorepository Resource Locations

PCPT and SELECT biospecimen resources are banked at the following locations:

PCPT

SELECT

Prostate tissue (cancer and normal):
University of Colorado, Dr. Lucia

Plasma, Red Blood Cell pellet: 
Leidos, Frederick National Lab

Serum:
University of Colorado, Dr. Lucia

White Blood Cells/DNA: 
Leidos, Frederick National Lab

White Blood Cells/DNA: 
Leidos, Frederick National Lab

Prostate tissue (cancers): 
University of Colorado, Dr. Lucia

 

Toenails:
Leidos, Frederick National Lab

 

Proposal Submission Process  

Proposal Review Process  

  • The SWOG Executive Review Committee will review the proposal, and an outcome letter will be communicated to the applicant via email.
  • After full SWOG Executive Review Committee approval is obtained, the Protocol Project Manager for PCPT and SELECT will provide instructions for obtaining NCI approval for use of the approved specimens.
  • The authorization for use of specimens is not considered final until the applicant enters into a Material and/or Data Use Agreement(s), agreeing to standard procedures for data analysis, data confidentiality, authorship, and intellectual property sharing.
  • Proposals which are not approved may be resubmitted if concerns are addressed or circumstances become more favorable.

Funding

  • Funding for proposed work is not part of this application process or approval consideration.
  • Funding does not need to be applied for or obtained in order to submit a proposal. However, funding must be obtained for the proposed work in order for materials to be released.
  • If funding is not obtained within a year of SWOG Review Committee approval, your proposal will be re-reviewed and approval may be withdrawn.

Distribution of specimens

The release of samples from the biorepositories indicated above will be authorized after the following have occurred:

  • Material and/or Data Use Agreement(s) are executed,
  • Funding is secured and any associated funding contracts are executed,
  • Documentation of IRB approval for the project is provided.

Questions

For questions or clarification: Contact the SWOG Network Operations Center (NOC) in San Antonio via Email: translationalmedicine@swog.org or at 210-614-8808.