PCPT and SELECT External Translational Medicine Proposal and Application Process
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
- To confirm the existence and availability of PCPT or SELECT biospecimens, complete the PCPT_SELECT Biorepository Form and submit to biospecimens@swog.org.
Biorepository Resource Locations
PCPT and SELECT biospecimen resources are banked at the following locations:
PCPT |
SELECT |
Prostate tissue (cancer and normal): |
Plasma, Red Blood Cell pellet: |
Serum: |
White Blood Cells/DNA: |
White Blood Cells/DNA: |
Prostate tissue (cancers): |
|
Toenails: |
Proposal Submission Process
- After confirmation of biospecimen availability, complete the Proposal for an External Translational Medicine Study and submit to translationalmedicine@swog.org.
- In the event that the translational medicine proposal is requesting utilization of slide images alone (and does not involve retrieval of actual physical specimens), complete the Data Request Template and submit to translationalmedicine@swog.org.
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.