Biospecimen Acquisition, Processing and Classification Unit

摘要-生物标本采集、处理和分类股 生物标本采集、处理和分类股（生物标本股）将负责 获得OMS Atlas活动的适当IRB批准和知情同意，收集、处理、验证 收集、分发和跟踪来自乳腺癌和前列腺癌患者的组织核心活检和血液样本， 参与研究的10名患者。具体而言，该股将使用一个11步样本采集管道， 根据现有IRB批准的方案开发。迄今在获得29套岩心方面取得的经验 来自27名患者的活检支持获得和维持知情同意、组织 保存，数据库登记，组织切片（冷冻和石蜡包埋），组织病理学评价， 测量、分发给研究人员，以及跟踪所有切片和其它样品衍生物（例如，核酸， 蛋白质提取物）。生物标本股将在这一经验的基础上努力实现以下目标： 在用特异性靶向药物治疗之前和期间从患者收集组织芯和血液样品， 和/或免疫疗法; 2）在采购管道中实施质量控制程序，以确保 只提供高质量的样本用于OMS图谱的构建;以及3）处理，验证， 及时跟踪和分发样品，供特性鉴定股分析。患者累计 将通过OHSU的电子临床研究信息系统进行跟踪，而所有标本将 访问生物库企业管理系统，这是一个支持完整的自定义数据库 使用唯一的10位数标识符/条形码跟踪所有样品和衍生物。患者结局数据将 以密码保护、加密、可通过网络访问的电子数据形式记录在电子病例报告表中 捕获系统生物样本单元将有具体的基准-密切监测-为患者 入组、成功完成第一次活检（至少4个穿刺）和成功完成第二次活检 活检，以实现三组中每组20个匹配对（治疗前和治疗中/治疗后）的最终目标 入组的患者。预计将提供任何剩余的生物标本或其衍生物 通过HTAN组织协调中心提供给其他研究者，并获得适当的IRB批准， 同意分享样品。

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.