Biospecimen Acquisition, Processing and Classification Unit

生物样本采集、处理和分类装置

基本信息

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
项目类别：
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

项目摘要

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 – 生物样本采集、处理和分类单元生物样本采集、处理和分类单位（生物样本单位）将负责观察为 OMS Atlas 活动、收集、处理、验证获得适当的 IRB 批准和知情同意收集、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具体来说，该装置将使用一个 11 步样品采集管道，该管道已经是根据 IRB 批准的现有协议开发的，迄今为止已获得 29 套核心的经验。 27 名患者的活检支持优化获得和维持知情同意、组织保存、数据库登录、组织切片（冷冻和石蜡包埋）、组织病理学评估化、分发给研究人员以及跟踪所有切片和其他样本衍生物（例如核酸、生物样本单元将在这一经验的基础上实现以下目标：1) 组织在特定目标治疗之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) 在收购管道中实施质量控制程序，以确保仅提供高质量样本来构建 OMS 图集；以及 3) 处理、验证、及时跟踪和分发样本，以供患者应计分析。将通过 OHSU 的电子临床研究信息系统进行跟踪，同时所有标本都将访问生物样本库企业管理系统，该系统是一个自定义数据库，支持完整的将使用唯一的 10 位标识符/条形码跟踪所有样本和衍生物。以受密码保护、加密、可通过网络访问的电子数据的电子病例报告形式捕获生物样本采集系统将为患者制定具体的基准并进行密切监控。登记、成功完成第一次活检（至少 4 个核心）以及成功完成第二次活检活检，以实现三组中每组 20 对（治疗前和治疗中/治疗后）匹配的最终目标预计将提供任何剩余的生物样本或其衍生物。通过 HTAN 组织协调中心向其他研究人员提供适当的 IRB 批准并知情同意样本共享。