Clinical Subjects and Biospecimen Core

临床受试者和生物样本核心

• 批准号: 9901432
• 负责人: Nirav Rati Bhakta
• 金额: $ 37.81万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9901432
• 关键词: Adrenal Cortex Hormones; Applications Grants; Asthma; Biological; Bronchoscopy; Cells; Cellular Assay; Clinical; Clinical Data; Clinical Research; Collection; Cryopreservation; Databases; Enrollment; Ensure; Epithelial; Epithelium; Freezing; Funding; Goals; Human; Inflammation; Inhalation; Institutional Review Boards; Link; Liquid substance; Longitudinal Studies; Methods; Molecular; National Heart, Lung, and Blood Institute; Nitrogen; Participant; Performance; Placebos; Preparation; Protocols documentation; RNA; Randomized; Regulation; Research; Resources; Saliva; Sampling; Secure; Specimen; Sputum; Suspensions; System; Time; Translational Research; United States National Institutes of Health; Visit; asthmatic; clinical phenotype; clinically significant; experience; experimental study; human subject; programs; recruit; single-cell RNA sequencing; success; transcriptome sequencing

PROJECT SUMMARY/ABSTRACT The Clinical Subject and Biospecimen Core will provide a core resource for the recruitment and characterization of human subjects, the completion of the clinical studies, and the collection and processing of biospecimens from these subjects. Recruiting human subjects for translational research protocols requires well-developed systems to ensure successful subject recruitment and the collection of high quality biospecimens from well-characterized human subjects. Dr. Nirav Bhakta (Core Director), Dr. Prescott Woodruff (Associate Core Director; also Associate Director of the UCSF Airway Clinical Research Center), along with a team consisting of a research coordinator, a technician, and a programmer analyst, have considerable experience in all aspects of these systems. Using the resources of this highly experienced and well-resourced group, the core will have four aims. Aim 1 is to recruit and enroll asthmatic subjects for the 1-year longitudinal study with bronchoscopy and sputum induction protocols to support Projects 1 and 2; this includes the management of IRB-related approvals and other regulatory paperwork for human research. Aim 2 is to collect high quality biospecimens from this new study using systems and methods which ensure compliance with federal and local regulations. Aim 3 is to bank and create database entries for biospecimens requested from three already-completed studies: 1) CLAVIER, a longitudinal bronchoscopy study with subjects randomized to lebrikizumab or placebo, 2) RITA, an 8-week longitudinal study with subjects randomized to inhaled corticosteroid (ICS) or no ICS, and 3) baseline bronchoscopy visit in the multi-center NIH/NHLBI-funded Severe Asthma Research Program (SARP). Aim 4 is to provide specialized processing, secure storage, and timely distribution of the human biospecimens collected from the clinical studies. In addition to providing very high quality clinical phenotyping and biological specimens from human subjects, this core will perform specialized 1) processing of induced sputum samples to achieve multiple Project-specific aims from the same sample, and 2) processing of epithelial brushings for subsequent culture, cryopreservation, single-cell RNA sequencing, and bulk cell RNA sequencing. For the bulk cell RNA sequencing of epithelial brushings, the core will perform RNA extractions and assessments of RNA quantity and quality. Given that human studies are an integral component of this grant application, this core will be critical for the successful performance of each Project and for establishing the clinical significance of the scientific studies proposed within them. Drs. Bhakta and Woodruff, and the Airway Clinical Research Center in which they conduct human studies, have a track record of success in humans subjects recruitment, characterization, research bronchoscopy and sputum induction, and in the processing, banking, database recording and distribution of high-quality biospecimens and RNA, as well as linking molecular and cellular assays to safely handled and validated databases of associated clinical data.

项目概要/摘要 临床受试者和生物样本核心将为招募和生物样本提供核心资源。 人类受试者的表征、临床研究的完成以及数据的收集和处理 来自这些受试者的生物样本。招募人类受试者进行转化研究方案需要 完善的系统确保成功的受试者招募和高质量的采集 来自特征明确的人类受试者的生物样本。 Nirav Bhakta 博士（核心主任）、Prescott Woodruff 博士 （核心副主任；加州大学旧金山分校气道临床研究中心副主任），以及 由一名研究协调员、一名技术员和一名程序员分析师组成的团队，拥有相当多的 这些系统各个方面的经验。利用这个经验丰富、资源丰富的资源 小组的核心将有四个目标。目标 1 是招募和入组为期 1 年的纵向哮喘受试者 研究支气管镜检查和痰诱导方案以支持项目 1 和 2；这包括 管理 IRB 相关批准和其他人类研究监管文件。目标2是收集 这项新研究使用确保符合标准的系统和方法获得高质量的生物样本 联邦和地方法规。目标 3 是为请求的生物样本存储并创建数据库条目 三项已完成的研究：1) CLAVIER，一项纵向支气管镜检查研究，受试者随机分为 lebrikizumab 或安慰剂，2) RITA，一项为期 8 周的纵向研究，受试者随机接受吸入 皮质类固醇 (ICS) 或无 ICS，以及 3) 在 NIH/NHLBI 资助的多中心进行基线支气管镜检查 严重哮喘研究计划 (SARP)。目标 4 是提供专门的处理、安全的存储和 及时分发从临床研究中收集的人体生物样本。除了提供非常 来自人类受试者的高质量临床表型和生物样本，该核心将执行 专业化 1) 处理诱导痰样本以实现同一项目的多个特定目标 样品，2) 处理上皮刷用于后续培养、冷冻保存、单细胞 RNA 测序和批量细胞 RNA 测序。对于上皮刷的大量细胞 RNA 测序，核心 将进行 RNA 提取以及 RNA 数量和质量的评估。鉴于人类研究是一门 作为本拨款申请的组成部分，该核心对于每个项目的成功实施至关重要 项目并确定其中提出的科学研究的临床意义。博士。巴克塔 和伍德拉夫，以及他们进行人体研究的气道临床研究中心，有一个跟踪 人类受试者招募、表征、研究支气管镜检查和痰的成功记录 优质生物样本的归纳、处理、银行、数据库记录和分发 和 RNA，以及将分子和细胞检测与安全处理和验证的数据库联系起来 相关的临床数据。