(EET Biobank) NCI Early-Phase and Experimental Clinical Trials Biospecimen Bank - CIMAC Supplement

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Project Summary The Biopathology Center (BPC), part of the Abigail Wexner Research Institute of Nationwide Children’s Hospital, houses the Experimental Therapeutics Clinical Trials Network (ETCTN) Biospecimen Bank (Biobank). In this project, the ETCTN Biobank will expand to include other National Cancer Institute (NCI)-supported early-phase and experimental trial networks and investigators and be known as the Early-Phase and Experimental Clinical Trials (EET) Biobank. The NCI supports a clinical trials infrastructure to facilitate the early stages of development and evaluation of anti-cancer therapeutic agents. The EET Biobank will promote a collection of standardized biospecimens by procuring, processing, banking, and distributing high-quality human biospecimens from cancer patients who participate in NCI Phases 0, I, and II trials and other experimental therapeutic cancer trials. EET clinical trials will include a range of cancer types (i.e., breast, lung, colon, prostate, leukemia, melanoma, lymphoma, and multiple myeloma). These biospecimens will be linked to detailed biospecimen-related data (including information on surgical, pathological, and radiological reports), as well as comprehensive clinical data, including detailed drug information, treatment histories/outcomes, and cancer recurrence data. The EET Biobank will work closely with study teams and investigators to ensure that biospecimens are handled appropriately for planned and future research. In these efforts, the EET Biobank will continue to support the processing, banking, and distribution of biospecimens to the Cancer Immune Monitoring and Analysis Centers (CIMACs). Biospecimens will first be distributed to investigators for planned research designed to meet the objectives included in the clinical trial. After the objectives in the clinical trial are met, the EET Biobank will then distribute biospecimens to qualified investigators for projects approved by the Cancer Therapy Evaluation Program (CTEP). The EET Biobank seeks to promote outstanding research through the banking of high-quality, clinically annotated, cancer-related human biospecimens. To support this effort, the EET Biobank will manage these biospecimens under strict guidelines and standard operating procedures based on current best practices for biorepositories, current regulatory guidelines, and the latest laboratory technologies. The EET Biobank will benefit from the BPC’s experience in supporting biobanking efforts for several NCI-funded groups, including the NCTN (Children’s Oncology Group [COG], SWOG [formerly the Southwest Oncology Group], NRG Oncology) and the ETCTN. Coupled with a firm commitment to quality and to the integrity of its operations, the EET Biobank will be uniquely able to provide an accurate and effective resource of high-quality tumor and normal samples with associated clinical and epidemiologic information.