Biospecimen Acquisition, Processing and Classification Unit

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Abstract – Biospecimen Acquisition, Processing and Classification Unit The Biospecimen Acquisition, Processing and Classification Unit (Biospecimen Unit) will be responsible for ob- taining appropriate IRB approval and informed consents for OMS Atlas activities, collecting, processing, validat- ing, distributing, and tracking tissue core biopsies and blood samples from the breast and prostate cancer pa- tients enrolled in the study. Specifically, the Unit will use an 11-step Sample Acquisition Pipeline that has already been developed under an existing IRB-approved protocol. Experience gained to date in obtaining 29 sets of core biopsies from 27 patients has supported the optimization of obtaining and maintaining informed consents, tissue preservation, database accessioning, tissue sectioning (frozen and paraffin-embedded), histopathologic evalu- ation, distribution to researchers, and tracking of all sections and other sample derivatives (e.g., nucleic acids, protein extracts). The Biospecimen Unit will build on this experience by pursuing the following Aims: 1) organizing the collection of tissue cores and blood samples from patients before and during treatment with specific targeted and/or immunotherapies; 2) implementing quality control procedures in the Acquisition Pipeline to ensure that only high quality specimens are provided for the construction of the OMS Atlas; and 3) processing, validating, tracking and distributing samples in a timely manner for analysis by the Characterization Unit. Patient accruals will be tracked through OHSU’s electronic Clinical Research Information system, while all specimens will be accessioned into the Biobank Enterprise Management System, which is a custom database that supports full tracking of all samples and derivatives using unique 10-digit identifiers/barcodes. Patient outcome data will be captured in electronic case report forms in a password-protected, encrypted, web-accessible electronic data capture system. The Biospecimen Unit will have specific benchmarks – to be closely monitored – for patient enrollment, successful completion of a first biopsy (minimum of 4 cores), and successful completion of a second biopsy, to achieve the final goal of 20 matched pairs (pre- and on/post-treatment) from each of the three groups of enrolled patients. It is anticipated that any leftover biospecimens or derivatives thereof will be made available to other researchers through the HTAN Tissue Coordination Center with appropriate IRB approval and informed consents for sample sharing.