Clinical Subjects and Biospecimen Core

项目摘要/摘要 临床学科和生物科学核心将为招聘和培训提供核心资源 人类受试者的特征，完成临床研究，以及收集和处理 来自这些受试者的生物标本。为翻译研究方案招募人类受试者需要 完善的制度，确保成功的学科招聘和高质量的征集 来自具有良好特征的人类受试者的生物标本。Nirav Bhakta博士(核心主任)、Prescott Woodruff博士 (加州大学旧金山分校航空临床研究中心副主任兼副核心主任)，以及 由一名研究协调员、一名技术人员和一名程序员分析师组成的团队拥有相当多的 在这些系统的各个方面都有经验。利用这一经验丰富、资源丰富的 集团，核心将有四个目标。目标1是招募和招募哮喘受试者参加为期1年的纵向试验 使用支气管镜和诱导痰方案进行研究，以支持项目1和2；这包括 管理与IRB相关的审批和其他人类研究的监管文书工作。目标2是收集 来自这项新研究的高质量生物检疫使用系统和方法确保遵守 联邦和地方法规。目标3是存储和创建数据库条目，用于从 三项已经完成的研究：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，受试者随机分为吸入组 3)多中心NIH/NHLBI资助的基线支气管镜检查 重症哮喘研究计划(SARP)。目标4是提供专门的处理、安全存储和 从临床研究中收集的人类生物寄生虫的及时分布。除了提供非常 高质量的临床表型和来自人类受试者的生物样本，这个核心将执行 专门化1)处理诱导痰样本，以实现同一项目的多个特定目标 样本，以及2)用于后续培养、超低温保存、单细胞RNA的上皮刷子的处理 测序和散装细胞RNA测序。对于上皮刷子的大宗细胞RNA测序，核心是 将进行RNA提取以及对RNA数量和质量的评估。鉴于人体研究是一种 作为这一赠款申请的组成部分，这一核心将是每个项目成功实施的关键 项目，并确定其中提出的科学研究的临床意义。巴克塔博士 伍德拉夫和他们在其中进行人体研究的Airway临床研究中心有一条轨迹 人类受试者招募、特征、支气管镜检查和痰研究的成功记录 诱导，并在加工、储存、数据库记录和分发高质量生物检疫菌方面 和RNA，以及将分子和细胞分析链接到安全处理和验证的数据库 相关的临床数据。

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.