Biospecimen Acquisition, Processing and Classification Unit

生物样本采集、处理和分类装置

• 批准号: 10005914
• 负责人: George Victor Thomas
• 金额: $ 4.47万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-19 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005914
• 关键词: Adopted; Aftercare; Aliquot; Antigen Presentation; Atlases; Bar Codes; Benchmarking; Biopsy; Biopsy Specimen; Blood specimen; Breast; CDK4 gene; Case Report Form; Castration; Cells; Chemicals; Classification; Clinical; Clinical Data; Clinical Research; Collection; Core Biopsy; Custom; Data; Databases; Diagnostic; Digit structure; Disease Progression; Disseminated Malignant Neoplasm; Drug or chemical Tissue Distribution; Enrollment; Ensure; Evaluation; Event; Extracellular Matrix; Freezing; Generations; Genomic Instability; Goals; Image; Immune; Immunomodulators; Immunotherapy; Individual; Information Systems; Informed Consent; Institutional Review Boards; Laboratories; Malignant neoplasm of prostate; Mechanics; Metadata; Metastatic breast cancer; Nucleic Acids; Paraffin Embedding; Pathologist; Pathway interactions; Patient Monitoring; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Primary Neoplasm; Procedures; Process; Production; Proteins; Protocols documentation; Quality Control; Research Personnel; Resistance; Sampling; Signal Transduction; Slide; Specific qualifier value; Specimen; Stains; System; Therapeutic; Time; Tissue Banks; Tissue Preservation; Tissues; Work; biobank; cancer cell; cohort; drug efficacy; electronic data capture system; encryption; epigenomics; exhaustion; experience; hormone receptor-positive; hormone therapy; immune checkpoint; immune resistance; individual patient; inhibitor/antagonist; malignant breast neoplasm; member; nanoscale; patient population; preservation; prospective; resistance mechanism; triple-negative invasive breast carcinoma; tumor; web-accessible

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.

摘要-生物质学家获取、处理和分类股 生物菌素购置、加工和分类股(生物菌素股)将负责物色、加工和分类股。 就OMS Atlas活动保持适当的IRB批准和知情同意，收集、处理、验证- 收集、分发和跟踪乳腺癌和前列腺癌患者的组织核心活检和血液样本。 蒂亚特参加了这项研究。具体地说，该股将使用一条11步样品采集管道，该管道已经 是在IRB批准的现有协议下开发的。到目前为止获得29套岩芯的经验 来自27名患者的活组织检查支持优化获得和维护知情同意、组织 保存，数据库访问，组织切片(冰冻和石蜡包埋)，组织病理学评估- 分离、分发给研究人员并跟踪所有部分和其他样品衍生物(例如，核酸， 蛋白质提取物)。生物检疫股将在这一经验的基础上实现以下目标：1)组织 在特定靶向治疗前和治疗期间收集患者的组织核心和血液样本 和/或免疫疗法；2)在采购管道中实施质量控制程序，以确保 只提供高质量的标本用于构建OMS地图集；以及3)加工、验证、 及时跟踪和分发样本，供定性股分析。患者应计费用 将通过OHSU的电子临床研究信息系统进行跟踪，而所有样本将被 加入Biobank企业管理系统，这是一个支持完整数据库的定制数据库 使用唯一的10位识别符/条形码跟踪所有样品和衍生品。患者结果数据将是 以受密码保护的、加密的、可通过Web访问的电子数据的电子病例报告形式捕获 捕获系统。生物检验科将为患者制定具体的基准--需要密切监测 登记，成功完成第一次活检(至少4个核心)，并成功完成第二次活检 活组织检查，以实现三组中每组20对配对(治疗前和治疗后)的最终目标 登记的病人的数量。预计任何剩余的生物杀虫剂或其衍生物都将可用 通过Htan组织协调中心提供给其他研究人员，并获得IRB的适当批准和通知 同意分享样本。