Biospecimen Banks Program for NCTN
Moves Forward With Approval From BSA
The NCI Board of Scientific Advisors approved a cooperative agreement to support the biospecimen banks for the NCI clinical trials network.
The agreement aims to consolidate the current cooperative group banks into a National Clinical Trials Network biospecimen banking networks for four adult groups and one pediatric group.
The RFA received unanimous approval at their Nov. 7 meeting.
This network is funded through a U24 cooperative agreement and supported by the Cancer Therapy Evaluation Program and Division of Career Development and Transition to conduct large-scale phase II and III trials in the U.S.
Run by the Division of Cancer Treatment & Diagnosis, the biospecimen banks would support banking infrastructure for prospective collection and storage of specimens on ongoing and new NCI trials, and serve as a cataloging and retrieval system for “legacy specimens” and specimen-associated data.
“The primary uses of the legacy specimens are the validation studies of predictive and prognostic markers,” said Irina Lubensky, chief of the Pathology Investigation & Resources Branch in the Cancer Diagnosis Program of the NCI Division of Cancer Treatment & Diagnosis.
Legacy specimens are specimens that remain in excess after clinical trial requirements have been met. The banks would aid in distributing the specimens to investigators following a defined NCTN access and approval of the study by expert review.
The RFA will support the NCTN biospecimen informatics navigator system, which will have a central database with inventory of specimens available for research and with integrated search engines for investigators.
“Our new RFA builds on the progress and the achievements of the current nine cooperative group banks that are named after the nine cooperative oncology groups,” Lubensky said at the Nov. 7 meeting. “These banks are an integral part of the NCTN and they are a very unique resource as they can provide well-annotated specimens and clinical data from these trials—such data do not really exist in many other resources.”
These nine cooperative oncology groups are in the process of reorganizing into four adult groups and one pediatric group—the Alliance for Clinical Trials in Oncology, NRG, ECOG-ACRIN, SWOG, and COG.
“These historically separate banks have been supported by cooperative agreement grants from our Cancer Diagnosis Program since 2005, and the progress made in establishing standard operating procedures of the banks, as well as activities and the steering group banking committee, did a lot of work in harmonizing the procedures,” Lubensky said. “Recently, in 2012, the division and NCI supported the supplement to development a common informatics navigator system for specimen access.”
Access to biospecimens will be expedited via the creation of a centralized “Front Door” specimen application process and a “Central Correlative Science” committee to review NCTN biospecimen proposals.
The cost for the five banks is estimated to total $58.75 million over five years.
BSA also approved:
• The Innovative Molecular Analysis Technologies initiative’s request for reissuance of four RFA solicitations proposes that the program will continue to account for majority of NCI’s support for investigator-initiated technology development, addressing an area unmet by other FOAs.
The request for reissuance received unanimous approval. IMAT is a trans-divisional initiative comprised of representatives from all extramural divisions of NCI, as well as members of the Office of the Director and the Center to Reduce Cancer Health Disparities.
IMAT solicitations continue to receive a substantial number of high-scoring applications and achieve “a significant record of success,” as verified by multiple external program outcome evaluations.
IMAT requested $5 million for about 20 new R21 grants and $4 million for about 12 new R33 grants per year for innovative and emerging molecular and cellular analysis technology development for cancer research.
IMAT also requested $800,000 to support about three new R21 grants and $700,000 for two new R33 grants per year for innovative and emerging technologies for cancer-relevant biospecimen sciences.
• The Pediatric Preclinical Testing Program seeks to enhance efficiency of childhood cancer clinical research—limiting lines of nonproductive research and provide evidence to support the presence or absence of a therapeutic window for specific agents against selected diseases.
The initiative was approved in favor of the proposal to open competition as an RFP, with one opposed and no abstentions.
PPTP aims to balance the inability of industry and clinical trials to validate results from the majority of publications on potential therapeutic targets by ensuring reliability of results through standard testing protocols, blinded testing and standard analytic metric for defining activity.
Run by the Cancer Therapy Evaluation Program, PPTP has a research contract with Peter Houghton of St. Jude Children’s Research Hospital as principal investigator and with six testing sites. Testing began in 2005, and PPTP has more than 80 executed MTA and has established collaborations with more than 50 companies.
Funding for PPTP in 2014 has not been decided. PPTP received $2.7 million per year in 2012 and 2013.
• The Molecular Characterization of Screen-Detected Lesions consortium proposes to support multidisciplinary research programs that undertake a comprehensive characterization of tumor cell and microenvironment components of screening-detected early lesions and missed interval cancers.
The RFA was approved unanimously.
Partners in the consortium would include molecular/cellular characterization laboratories, the Coordination and Data Management Group, and six NIH programs—EDRN, TMEN, NCATS, PLCO, PROSPR, and BETRNet.
Run by the Division of Cancer Prevention, the consortium aims to standardize data collection protocols and analyses, create a national resource for valuable samples of screen-detected and of interval cancers for future use, and centralize IRB management, material transfer agreements and protocols.
Applications to join the consortium will be required to include collaborative arrangement with existing or ongoing biospecimen networks or consortia as a partner, demonstrate the ability to procure appropriate specimens for the proposed study and share samples across the consortium on cross-laboratory discovery and verification.
The consortium is estimated to cost $5 million per year for five years.
• The Metabolic Reprogramming to Improve Immunotherapy initiative aims to generate a mechanistic understanding of the metabolic processes that support robust anti-tumor immune responses in vivo.
The concept is being developed and no vote was taken.
Run by the Division of Cancer Biology, the initiative seeks to determine how the metabolic landscape of the tumor microenvironment affects immune effector functions, and to use this information to manipulate or reprogram the metabolic pathways used by the tumor, the effectors of the immune response, or both to improve cancer immunotherapy.
The initiative plans to form collaborations between tumor immunologists, cancer biologists, computational modelers, and tool/technology specialists aimed at developing innovative approaches to utilize metabolic reprogramming to improve cancer immunotherapy.
To join the collaboration, applicants must propose cross-disciplinary research involving cancer biologists and immunologists aimed at complementary areas of metabolic research and, if justified, metabolomics, computational tools, or an imaging component.
The funding mechanism for this initiative proposes to supplement existing NCI funded grants to support collaborative research projects through revision applications. No budget has been set aside for the initiative.