Clinical Subjects and Biospecimen Core

项目总结/摘要 临床受试者和生物样本核心将为招募提供核心资源， 人类受试者的表征、临床研究的完成以及 这些实验对象的生物样本为转化研究方案招募人类受试者需要 完善的系统，以确保成功的受试者招募和收集高质量的 生物样本来自特征良好的人类受试者。Nirav Bhakta博士（核心总监）、Prescott Woodruff博士 （副核心主任;也是UCSF气道临床研究中心的副主任），沿着， 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， 这些系统的各个方面的经验。利用这个经验丰富资源充足的 核心将有四个目标。目的1是招募和入组哮喘受试者进行1年纵向研究， 支气管镜检查和痰诱导方案研究，以支持项目1和2;这包括 管理IRB相关批准和其他人体研究监管文书工作。目标2是收集 这项新研究使用的系统和方法可确保符合 联邦和地方法规。目标3是为从以下国家请求的生物标本建立数据库并创建数据库条目： 3项已完成的研究：1）CLAVIER，一项纵向支气管镜检查研究，受试者随机分配至 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，和3）在多中心NIH/NHLBI资助的 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采集的人体生物标本。除了提供非常 高质量的临床表型和生物样本从人类受试者，这个核心将执行 专业化1）处理诱导痰样本，以实现多个项目特定的目标，从同一个 样品，和2）处理上皮刷毛用于随后的培养、冷冻保存、单细胞RNA 测序和批量细胞RNA测序。对于上皮刷毛的大量细胞RNA测序，核心 将进行RNA提取和RNA数量和质量的评估。鉴于人类研究是一个 这一赠款申请的组成部分，这一核心将是每个成功的表现至关重要 项目，并确定其中提出的科学研究的临床意义。巴克塔博士 和伍德拉夫，以及他们进行人体研究的气道临床研究中心， 人类受试者招募、表征、支气管镜检查和痰液检查的成功记录 在高质量生物标本的处理、储存、数据库记录和分发方面， 以及将分子和细胞测定与安全处理和验证的 相关临床数据。

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.