The NRG Oncology Biospecimen Bank (NRG BB) is the central biorepository for biospecimens collected from patients enrolled in NRG Oncology 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 Oncology Statistical and Data Management Center (NRG SDMC).
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) Banks access policies and who have funding to support their project (https://nctnbanks.cancer.gov/).
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 of NRG Oncology clinical trials must be submitted through Navigator. Please refer to the Navigator website (https://navigator.ctsu.org/) for additional details, a list of available trials, and/or to begin the biospecimen request process. The Navigator Front Door Service (FDS; email@example.com) is available to address any further questions or concerns regarding Navigator.
All Other NRG Oncology Biospecimen Requests
To request biospecimens from trials not available in Navigator, please use the following procedure (forms and processes are similar to those used for Navigator):
1.) It is strongly recommended that investigators research the availability of biospecimens at https://nctnbanks.cancer.gov// and by directly contacting the NRG BB prior to submitting a request. For questions about the process please contact BiospecimenAccess@NRGoncology.org.
2.) Complete the Letter of Intent (LOI) and submit it to NRG Oncology at BiospecimenAccess@NRGoncology.org. Once received, NRG Oncology will assign a staff member to work with the investigator throughout the review process.
3.) The LOI will be reviewed by NRG Oncology. The investigator will be provided a preliminary evaluation of the overall feasibility of the project, including biospecimen and 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.
4.) If the proposal 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 Oncology will review the proposal and, upon approval, staff will work with the investigator, as appropriate, to refine the application prior to submission to the NCTN Core Correlative Science Committee (CCSC; https://ctep.cancer.gov/initiativesPrograms/nctn_ccsc_overview.htm) for review and approval.
5.) The NCTN CCSC will review the proposal for scientific merit and alignment with the goals of the NCTN. The NCTN CCSC will provide written comments of their review.
6.) If the proposal is approved by the NCTN CCSC, the investigator will work with NRG Oncology to complete the regulatory and legal documentation needed prior to distribution of biospecimens. The documentation required includes:
- Institutional Review Board (IRB)/Ethics Committee (EC) review/approval notification from the investigator’s institution
- Material Transfer Agreement (MTA)
- Funding commitment (The investigator must have sufficient funds available to cover expenses related to distribution of biospecimens.)
- Data Transfer Agreement (DTA), if appropriate, for the transfer of clinical data
7.) Investigators are required to notify NRG Oncology of any publications that result from the use of NRG Oncology biospecimens.
For questions regarding this process, please contact BiospecimenAccess@NRGoncology.org.
Biospecimen Collection, Processing, and Shipping Inquiries
Nurses and CRAs with questions about biospecimen collection, processing, and shipping should refer to the following webpage for additional information: https://www.nrgoncology.org/Nurses-CRAs/Biospecimen-Bank.