The NRG Oncology Biospecimen Bank (NRG BB) is the biorepository for biospecimens collected from patients enrolled in NRG clinical trials (as well as the legacy Group trials of NSABP, RTOG, and GOG). This collection includes but is not limited to paraffin-embedded and frozen tissues; blood products such as whole blood, plasma, serum, and buffy coats; nucleic acids (DNA, RNA); urine and stool. Extensive clinical and outcome data exist for most of these biospecimens and can be provided by the NRG Statistical and Data Management Center (SDMC).
The NRG BB provides annotated, de-identified, and, if required, anonymized biospecimens to qualified investigators who comply with National Cancer Institute (NCI) National Clinical Trials Network (NCTN) Biobanks access policies and who have funding to support their project.
Requesting NRG Oncology Biospecimens through NCI’s NCTN Navigator
Since the launch of NCI’s NCTN Navigator (Navigator) on April 2, 2018, requests for biospecimens from many NRG clinical trials must be submitted through Navigator. Please refer to the Navigator website for additional details, a list of available trials, and/or to begin the biospecimen request process. The Navigator Front Door Service (FDS) is available to address any further questions or concerns regarding Navigator.
To request biospecimens from NRG NCORP trials, please use the procedure outlined in the All Other NRG Oncology Biospecimen Requests section.
A listing of NRG NCORP trials with available biospecimens can be found here.
All Other NRG Oncology Biospecimen Requests
- Investigators must research the trial(s) from which they are requesting biospecimens. This includes, but is not limited to, trial design, biospecimen and clinical data collection, as well as publication of trial objectives and other correlatives. Useful resources include:
ClinicalTrials.gov -– A database of privately- and publicly-funded clinical studies conducted around the world.
Cancer Trials Support Unit (CTSU) – A service of the NCI designed to facilitate access to NCI-funded clinical trials for qualified clinical sites and to support the management and conduct of these trails.
Most biospecimen collections from NCTN clinical trials are annotated with carefully collected clinical data. As such, use of these valuable, irreplaceable biospecimens for hypothesis-generating studies is not appropriate.
Investigators should review the NCTN Core Correlative Sciences Committee (CCSC) guidelines regarding access to NCTN biospecimens before submitting a request for these biospecimens.
If the investigator is requesting biospecimens for hypothesis-generating or exploratory studies, the investigator should explore additional biospecimens resources. The NCTN Specimen Resource Locator is a database designed to help researchers identify such resources.
NRG Publication Search – Allows investigators to search for publications resulting from clinical trials and correlative studies conducted through NRG Oncology.
- Once an investigator has identified the appropriate NRG trial(s) from which to request biospecimens, the investigator should complete a Letter of Intent (LOI) and submit it to NRG at BiospecimenAccess@NRGoncology.org. Once received, NRG will assign a staff member to work with the investigator throughout the review process.
- The LOI will be reviewed by NRG. The investigator will be provided a preliminary evaluation of the overall feasibility of the project, including biospecimen and clinical data availability, as well as the appropriateness of the research question. The investigator will also be provided an estimate of the minimum costs associated with biospecimen distribution and any statistical services requested.
- If the LOI is determined to be feasible, the investigator will be instructed to complete the NCTN CCSC Proposal Submission Form and submit it along with all letters of collaboration to BiospecimenAccess@NRGoncology.org. NRG will submit the completed proposal packet to NCI for review and approval.
- The NCI will review the proposal for scientific merit and alignment with the goals of the NCTN. The investigator will be provided with written comments from the NCI review.
- If the proposal is approved by NCI, the investigator will work with NRG to complete the regulatory and legal documentation required prior to distribution of biospecimens. This documentation includes:
- Institutional Review Board (IRB)/Ethics Committee (EC) approval from investigator’s institution
- Material Transfer Agreement (MTA)
- Funding commitment
- Data Transfer Agreement (DTA), if applicable
- Investigators are required to notify NRG of any publications that result from the use of NRG biospecimens and must acknowledge the appropriate NRG grant numbers in these publications.
For questions regarding this process, please contact BiospecimenAccess@NRGoncology.org.
Biospecimen Collection, Processing, and Shipping Inquiries
For questions about biospecimen collection, processing, and shipping, please refer to the NRG Oncology Biospecimen Bank webpage.