Biospecimen Acquisition, Processing and Classification Unit

生物样本采集、处理和分类装置

• 批准号: 9627376
• 负责人: E.Shelley Hwang
• 金额: $ 158.96万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9627376
• 关键词: Atlases; Biological Assay; Breast; Carcinoma; Classification; Clinical; Clinical Management; Clinical Trials; Collaborations; Consent; Data; Data Analyses; Drug or chemical Tissue Distribution; Ecology; Ensure; Equipment and supply inventories; Evolution; Fresh Tissue; Future; Goals; Image; Individual; Institutes; Institutional Review Boards; Malignant Neoplasms; Metadata; Modeling; Molecular; Noninfiltrating Intraductal Carcinoma; Pathologic; Pathology; Procedures; Process; Protocols documentation; Recurrence; Research Infrastructure; Research Personnel; Resource Sharing; Risk; Sampling; Shipping; Site; Specimen; Stratification; Structure; System; Tissue Banks; Tissue Procurements; Tissue Sample; Universities; Washington; anticancer research; base; biobank; cancer invasiveness; case control; cohort; data management; data sharing; design; flexibility; malignant breast neoplasm; molecular marker; organizational structure; prospective; sample collection; surveillance study; tumor; tumor progression; virtual

ABSTRACT – Biospecimen Unit The breast Precancer Atlas (B-PCA) will elucidate the imaging, molecular, and microenvironment differences that influence evolution and ecology of the tumor and are associated with invasive cancer progression. The objective of the Biospecimen Unit is to collect retrospective and prospective tissue samples of DCIS from which to construct the Atlas, selecting those cohorts and cases which are likely to be most informative for Atlas construction. The Biospecimen Unit of the B-PCA will be responsible for properly, reliably, and efficiently executing all aspects of sample collection, while ensuring alignment with the overall scientific goals of the project. The Unit will oversee all procedures related to specimen acquisition, storage, tracking, and distribution to support the activities of the B-PCA investigators. The Biospecimen Unit is comprised of 3 primary sites (Duke, Stanford, and Washington University) which will each manage specimen acquisition in accordance with individual institutional procedures. In addition, there will be virtual centralized coordination of all B-PCA activities related to specimen annotation and distribution. The Biospecimen Unit will coordinate shared resources, including multicenter case-control matched sets of DCIS collected through Washington University, the Translational Breast Cancer Research Consortium (TBCRC), and prospective clinical trial samples from COMET, an active surveillance study for low risk DCIS. Integration between the Characterization and Data Analysis Units of the B- PCA will be promoted by the shared data infrastructure, including access to metadata to facilitate sharing of samples and data. Processes and procedures around specimen collection, sample annotation, and tissue distribution will be governed through shared SOPs, MTAs/DUAs and harmonized IRB protocols. The overarching goals of the Biospecimen Unit are: 1) to create the organizational structure and processes necessary to support these activities, and 2) to use this infrastructure to collect, track, and distribute samples, based upon the needs of the B-PCA investigators. The structure of the Biospecimen Unit has been designed to be flexible and scalable in order to accommodate future collaboration around specimen collection and sample characterization across the PCA centers and the HTAN.

摘要 - 生物循环单元 乳房促剂地图集（B-PCA）将阐明成像，分子和微环境差异 这会影响肿瘤的进化和生态，并与侵入性癌症进展有关。这 生物测量单元的目的是收集DCI的回顾性和前瞻性组织样本 要构建地图集，选择那些可能对Atlas最有用的群体和案例 建造。 B-PCA的生物循环单元将负责正确，可靠和有效 执行样本收集的各个方面，同时确保与项目的整体科学目标保持一致。 该单元将监督与标本获取，存储，跟踪和分配有关的所有程序以支持 B-PCA调查人员的活动。 Biospecimen单元由3个主要地点组成（杜克，斯坦福， 华盛顿大学）每个人都会根据个人管理标本的收购 机构程序。此外，将对所有B-PCA活动进行虚拟集中协调 标本注释和分布。 Biospecimen单元将协调共享资源，包括 多中心案例对照匹配的DCIS组通过华盛顿大学收集，这是翻译乳房 癌症研究联盟（TBCRC）和来自彗星的前瞻性临床试验样本 低风险DCI的监视研究。 B-的表征和数据分析单元之间的集成 PCA将由共享数据基础架构提升，包括访问元数据以促进共享 样本和数据。试样收集，样品注释和组织围绕样品的过程和程序 分配将通过共享的SOP，MTA/DUA和协调的IRB协议来管辖。总体 生物测量单元的目标是：1）创建支持的组织结构和过程 这些活动，以及2）使用此基础架构根据需求收集，跟踪和分发样本 B-PCA调查人员。 Biospecimen单元的结构已设计为灵活且可扩展的 为了适应围绕标本收集和样本表征的未来合作 PCA中心和HTAN。