April 29 2022
Date Issued: April 29, 2022
Letter of Intent Submission Due Date: June 24, 2022
Reply to: BiospecimenAccess@NRGoncology.org and fielde@nrgoncology.org
Summary
NRG Oncology NCORP is soliciting PILOT projects for applications focused on biospecimens and clinical trial data from the following breast cancer prevention studies. The intent is to develop pilot data and hypotheses for future NRG Oncology primary or secondary outcomes in clinical trials.
NSABP P-1: Breast Cancer Prevention Trial/BCPT: A Clinical Trial to Determine the Worth of Tamoxifen for Preventing Breast Cancer
To learn more about the study, the primary results publication can be found at:
Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst 1998; 90:1371-1388.
https://pubmed.ncbi.nlm.nih.gov/9747868/
NSABP P-2: Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
To learn more about the study, the primary results publication can be found at:
Vogel VG, Costantino JP, Wickerham DL, et al. Effects of tamoxifen vs. raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. https://pubmed.ncbi.nlm.nih.gov/16754727/
A QUICK GLANCE AT AVAILABLE BIOSPECIMENS:
| | NSABP P-1 (BCPT) | NSABP P-2 (STAR) |
| Blood: Buffy coat and Plasma | 73,218 total specimens | 154,541 total specimens |
| Tissue blocks (FFPE) | 11,432 total specimens | 16,197 total specimens |
| Isocode cards | N/A | 19,810 |
| RBCs | N/A | 38,590 |
Note: Confirmation of eligible biospecimens/patients available will be determined upon proposal approval and physical verification of inventory.
How to Apply
Funding can be requested for up to $75,000 and is contingent upon project review by NRG leaders and NRG Oncology’s receipt of the Notice of Award from the Division of Cancer Prevention (DCP). Funding for the use of these biospecimens is also conditional upon approval from NCI/DCP.
One to two projects may be funded.In order to be considered, applications must submit a Letter of Intent (LOI) (located on the NRG website) by June 24, 2022 and if awarded funded projects must be completed by December 31, 2024. The review for the award is a multi-step process:
- Submit LOI (as noted above)
- Once the LOI is received it will be reviewed by NRG and the investigator will be provided an evaluation of the feasibility of the project by Monday, August 8, 2022.
- If the proposal is deemed feasible, the investigator will be notified and instructed to complete the NCTN CCSC Proposal Submission Form along with the following documents:
- One-page letter of support signed with the department chair specifically stating they will or will not wave F&A and cost share
- Timeline for the project
- NIH biosketch of PI
- A detailed budget
- NRG will review the proposal and if approved, NRG staff will closely work with the investigator to submit to NCI for final review and approval.
These documents along with all letters of collaboration will be submitted to BiospecimenAccess@NRGoncology.org and NRG NCORP Administrator, Erica Field (fielde@nrgoncology.org). You will be provided a deadline for this submission.
Budget
Please work with your institution's Sponsored Research Office (SRO) in developing the project budget and ensure that the SRO has approved the application and budget. Applications from institutions that are able to waive indirect costs and/or provide cost sharing, while not mandatory, will be prioritized.
Funding
No carry over funds will be issued. An interim progress report is due at 6 months prior to receipt of additional funding, one year after award notification and a completed progress report is due at the end of the project period. It is the prerogative of the Chairs of the NRG NCORP Cancer Prevention and Control Committee to request the study team to present interim progress and final results at semi-annual NRG meetings.
If your project is funded, a sub-award agreement with terms and conditions of the award will be issued to the institution. Any resulting publication is subject to review by NRG Oncology and NCI/DCP.
Funds will be reimbursed upon receipt of invoices with subsequent payments upon approval of progress in the first 6 months of the project.
Instructions for Applicants
If you have an interest in this application, please submit a Letter of Intent (LOI) along with documents noted in step 1 above by 5pm ET, Friday, June 24, 2022. This opportunity is open to all investigators. Applications from junior investigators with qualified mentors and those from minority backgrounds will also be prioritized.
Submit applications to:
NRG Biospecimen Access
BiospecimenAccess@NRGoncology.org
Erica Field, MPH, MHA
fielde@nrgoncology.org
Direct scientific questions to NRG NCORP PI and CPC Chairs:
Deborah Watkins Bruner, RN, PhD, FAAN
NCORP PI
deborah.w.bruner@emory.edu
Joan Walker, MD
NCORP PI
Joan-Walker@ouhsc.edu
Lisa Kachnic, MD
NCORP Associate Chair; Chair, Cancer Control
lak2187@cumc.columbia.edu