Biospecimen Acquisition, Processing and Classification Unit

生物样本采集、处理和分类装置

基本信息

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 患者参加了这项研究。具体来说,该单位将使用一个 11 步样品采集管道,该管道已经 是根据现有的 IRB 批准的协议开发的。迄今为止获得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、 蛋白质提取物)。生物样本组将以此经验为基础,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) 在采购管道中实施质量控制程序,以确保 只为 OMS Atlas 的构建提供高质量的样本; 3) 处理、验证、 及时跟踪和分发样品以供表征部门进行分析。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,同时所有标本都将 加入生物样本库企业管理系统,这是一个自定义数据库,支持完整的 使用独特的 10 位标识符/条形码跟踪所有样品和衍生物。患者结果数据将是 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 捕获系统。生物样本单元将为患者制定具体的基准,并进行密切监测 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 入组患者的数量。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。

项目成果

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George Victor Thomas其他文献

George Victor Thomas的其他文献

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{{ truncateString('George Victor Thomas', 18)}}的其他基金

Novel Treatment Strategies for Cancer
癌症新治疗策略
  • 批准号:
    10193053
  • 财政年份:
    2021
  • 资助金额:
    $ 1.73万
  • 项目类别:
Developing novel polytherapies for Non-Clear Cell Renal Cell Carcinoma
开发非透明细胞肾细胞癌的新型多疗法
  • 批准号:
    10555185
  • 财政年份:
    2021
  • 资助金额:
    $ 1.73万
  • 项目类别:
Developing novel polytherapies for Non-Clear Cell Renal Cell Carcinoma
开发非透明细胞肾细胞癌的新型多疗法
  • 批准号:
    10308505
  • 财政年份:
    2021
  • 资助金额:
    $ 1.73万
  • 项目类别:
Biospecimen Acquisition, Processing and Classification Unit
生物样本采集、处理和分类装置
  • 批准号:
    10005914
  • 财政年份:
    2018
  • 资助金额:
    $ 1.73万
  • 项目类别:
Biospecimen Acquisition, Processing and Classification Unit
生物样本采集、处理和分类装置
  • 批准号:
    10246895
  • 财政年份:
    2018
  • 资助金额:
    $ 1.73万
  • 项目类别:
Inhibiting VHL-positive kidney cancer
抑制 VHL 阳性肾癌
  • 批准号:
    9246441
  • 财政年份:
    2013
  • 资助金额:
    $ 1.73万
  • 项目类别:
Inhibiting VHL-positive kidney cancer
抑制 VHL 阳性肾癌
  • 批准号:
    8634752
  • 财政年份:
    2013
  • 资助金额:
    $ 1.73万
  • 项目类别:
Inhibiting VHL-positive kidney cancer
抑制 VHL 阳性肾癌
  • 批准号:
    8503820
  • 财政年份:
    2013
  • 资助金额:
    $ 1.73万
  • 项目类别:
Inhibiting VHL-positive kidney cancer
抑制 VHL 阳性肾癌
  • 批准号:
    9038327
  • 财政年份:
    2013
  • 资助金额:
    $ 1.73万
  • 项目类别:
Biolibrary and Pathology
生物图书馆和病理学
  • 批准号:
    10205354
  • 财政年份:
    1997
  • 资助金额:
    $ 1.73万
  • 项目类别:

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机构外的生活:1900 - 1960 年心理健康善后护理的历史
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