NRG Oncology (NRG) is a newly constituted National Clinical Trials Network (NCTN) group created through the coordinated efforts and scientific merger of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). The NRG Oncology Biospecimen Bank (NRG-BB) will be formed from the three legacy biospecimen resources of the RTOG, GOG and NSABP into a single repository for all biospecimens collected as part of NRG Oncology clinical trials. NRG Oncology and the NCI have agreed to enroll up to 5,099 patients per year in future NCI-funded NRG-sponsored cancer clinical trials. We will collect, process and manage biospecimens from patients enrolled in Phase II & III clinical treatment trials to maintain an accurate and effective repository of tumor and normal tissues with associated clinical, epidemiologic, and descriptive biospecimen information, for use in trial-related activities and future translational science projects. The NRG-BB will maximize the quality and quantity of biospecimens and their derivatives through the utilization of standardized and optimal preservation, storage, quality assurance and distribution methods. We will market and distribute de-identified samples in a standardized and equitable manner to all qualified investigators both within and outside NRG Oncology by utilizing Biospecimen IT Navigator and NCTN Biospecimen front door services. Working with the biobanks from other NCTN groups and the Group Banking Committee of the NCI, we will harmonize biospecimen activities and processes. Finally, we will develop distributed infrastructure to support and/or perform innovative genomic analyses for patient assignment to multi-arm targeted therapy trials conducted by NRG Oncology. Robust informatics is required to allow translational scientists to know what is available within the NRG-BB and to equitably distribute biospecimens to the translational science community both within and outside NRG Oncology. We have anticipated this need by already harmonizing and consolidating our IT resources using a common Specimen Tracking and Reporting System (STARS) bioinformatics platform. This adoption of a common IT platform across the 3 legacy biospecimen banks has permitted an improved service level for the group, interoperability and freely exchangeable data with our NRG-BB partners and opportunities to enhance our links with the SDMC. Moreover, this new platform has permitted better external linkages with the Group Banking Committee, the NCI and with the Navigator and Front Door project.

Public Health Relevance

The collection, management and distribution of high quality and well annotated biospecimens associated with NRG clinical trials data will lead to translational studies for validating biomarkers of tumor prognosis and prediction of response to therapy, ultimately leading to improved treatment of cancer patients. These activities will support improved quality of biospecimens and expanded access for translational scientists, thus leading to better quality research and identifying appropriate patients for personalized approaches to improved cancer care.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24CA196067-04
Application #
9441724
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Makhlouf, Hala
Project Start
2015-04-22
Project End
2020-03-31
Budget Start
2018-04-01
Budget End
2019-03-31
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Nrg Oncology Foundation, Inc.
Department
Type
DUNS #
078695317
City
Philadelphia
State
PA
Country
United States
Zip Code
19103
Kim, S Rim; Song, Nan; Yothers, Greg et al. (2018) Tumour sidedness and intrinsic subtypes in patients with stage II/III colon cancer: analysis of NSABP C-07 (NRG Oncology). Br J Cancer 118:629-633
Lawrence, Yaacov R; Moughan, Jennifer; Magliocco, Anthony M et al. (2018) Expression of the DNA repair gene MLH1 correlates with survival in patients who have resected pancreatic cancer and have received adjuvant chemoradiation: NRG Oncology RTOG Study 9704. Cancer 124:491-498
Geyer Jr, Charles E; Tang, Gong; Mamounas, Eleftherios P et al. (2018) 21-Gene assay as predictor of chemotherapy benefit in HER2-negative breast cancer. NPJ Breast Cancer 4:37
Bell, Erica H; Zhang, Peixin; Fisher, Barbara J et al. (2018) Association of MGMT Promoter Methylation Status With Survival Outcomes in Patients With High-Risk Glioma Treated With Radiotherapy and Temozolomide: An Analysis From the NRG Oncology/RTOG 0424 Trial. JAMA Oncol 4:1405-1409
Ablain, Julien; Xu, Mengshu; Rothschild, Harriet et al. (2018) Human tumor genomics and zebrafish modeling identify SPRED1 loss as a driver of mucosal melanoma. Science 362:1055-1060
Aghajanian, Carol; Filiaci, Virginia; Dizon, Don S et al. (2018) A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer. Gynecol Oncol 150:274-281
Weidhaas, Joanne B; Harris, Jonathan; Schaue, Dörthe et al. (2017) The KRAS-Variant and Cetuximab Response in Head and Neck Squamous Cell Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol 3:483-491
Thaker, Premal H; Brady, William E; Lankes, Heather A et al. (2017) A phase I trial of intraperitoneal GEN-1, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer, administered with pegylated liposomal doxorubicin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal Gynecol Oncol 147:283-290
Rader, Janet S; Sill, Michael W; Beumer, Jan H et al. (2017) A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol 145:291-297
Thaker, P H; Salani, R; Brady, W E et al. (2017) A phase I trial of paclitaxel, cisplatin, and veliparib in the treatment of persistent or recurrent carcinoma of the cervix: an NRG Oncology Study (NCT#01281852). Ann Oncol 28:505-511

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