Project Summary ECOG-ACRIN (EA) represents the merger of ECOG and ACRIN to form a cooperative group focused on practice-changing clinical and translational research across the cancer care continuum from cancer prevention and early detection, through the management of advanced disease and its impact. This application is to support the infrastructure and banking operations for the EA Central Biorepository and Pathology Facility (EA CBPF), a highly collaborative, productive and impactful biorepository resulting from the consolidation of five NCI National Clinical Trials Network (NCTN) Biospecimen Banks, including one currently finalizing transition. The consolidation of biorepository activities into EA CBPF has significantly impacted operations by centralizing and continuing the standard and innovative biorepository activities and enhancing capabilities to develop novel predictive biomarkers and therapeutic approaches in cancer. EA CBPF will continue being assisted by the EA Biostatistics and Data Management Center (BDMC), Operations Offices, other NCTN units, NCI-sponsored programs and investigators, and the NCI. The goal of EA CBPF is to ensure the collection, storage, and distribution of well-annotated human biospecimens, procured from cancer patients participating in the NIH/NCI and NCTN NCI-funded clinical treatment trials. EA CBPF's Aim 1 is to collect, process, store, catalog, and distribute malignant and non-malignant tissues, cells, blood, and other fluid specimens and their derivatives (e.g., tissue-derived and cell free DNA and RNA, proteins, exosomes and circulating tumor cells) from patients enrolled in EA clinical trials following the NCI's “Best Practices for Biospecimen Resources” and to link the specimens to relevant clinical, pathologic, immunological and molecular data within the NCTN program; Aim 2 is to develop and utilize both routine and innovative biospecimen resources that will aid in the successful completion of NCTN-supported clinical trials based on integral biomarkers and of related correlative studies to promote the development of novel biomarker-driven personalized cancer therapeutic strategies; Aim 3 is to develop capabilities for performing classic and molecular methodologies on tissue, cell, blood, and other body fluid–based specimens from EA clinical trial patients, including planned future consolidation of specimen-based functions, and provide expert interpretation of the findings in close collaboration with the investigators leading the related NCTN- supported clinical trials; and Aim 4 is to assist investigators outside and within the NIH/NCI NCTN and NCORP to access biospecimens for research by participating actively, and leading efforts in high priority programs such as the NCTN Navigator services and the Center for Immune Monitoring of Cancer (CIMAC), as well as contributing actively to the biorepository harmonization activities of the NCI Group Banking Committee (GBC) and NIH/NCI-supported specimen banking organizations.

Project Narrative The ECOG-ACRIN Central Biorepository and Pathology Facility (EA CBPF) will receive process, store and distribute high quality, well-annotated tissue specimens as well as blood and other biological fluids from patients participating in NCTN and NCORP clinical trials and assist NIH/NCI-supported specimen banking organizations. The specimens will encompass tumor and non-malignant tissue and cytology specimens, peripheral blood, bone marrow, and other fluid samples, from multiple tumor sites (e.g., tumors of the brain, breast, gastrointestinal tract, genitourinary tract, gynecologic/reproductive system, head and neck, skin, liver, lung, soft tissue, thyroid gland and other cancers) and hematologic malignancies (leukemia, lymphoma, and multiple myeloma and related diseases).