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.

项目摘要/摘要 临床主题和生物传播核心将为招聘提供核心资源和 人类受试者的表征，临床研究的完成以及收集和处理 这些主题的生物测量。招聘人类主题进行转化研究协议需要 发达的系统，以确保成功招聘的成功和高质量的收集 来自特征良好的人类受试者的生物测量。 Nirav Bhakta博士（核心总监），Prescott Woodruff博士 （副局长；也是UCSF气道临床研究中心的副主任） 由研究协调员，技术人员和程序员分析师组成的团队拥有相当大的 在这些系统的各个方面的经验。利用这种经验丰富且资源丰富的资源 小组，核心将有四个目标。 AIM 1是为期1年纵向招募和招募哮喘科目 用支气管镜检查和痰诱导方案进行研究，以支持项目1和2；这包括 与IRB相关的批准和其他监管文书的管理。目标2是收集 这项新研究的高质量生物测量使用系统和方法确保符合 联邦和地方法规。 AIM 3是为从要求的生物测量的数据库条目并创建数据库条目 三项已经完成的研究：1）Clavier，一项纵向支气管镜检查研究，被随机分为 Lebrikizumab或安慰剂，2）Rita，一项为期8周的纵向研究，被随机吸入的受试者 皮质类固醇（ICS）或无ICS，3）在多中心NIH/NHLBI资助的基线支气管镜检查 严重的哮喘研究计划（SARP）。 AIM 4是提供专业的处理，安全存储和 从临床研究中收集的人类生物测量的及时分布。除了提供非常 高质量的临床表型和人类受试者的生物标本，该核心将执行 专业1）处理诱导的痰液样品以实现从同一目标实现多个特定于项目的目标 样本和2）处理上皮刷子以进行后续培养，冷冻保存，单细胞RNA 测序和大量细胞RNA测序。对于上皮刷子的散装细胞RNA测序，核心 将对RNA提取和RNA数量和质量进行评估。鉴于人类研究是 此赠款应用程序的整体组成部分，该核心对于每个核心的成功表现至关重要 项目并确定其中提出的科学研究的临床意义。博士。巴克塔 和伍德拉夫（Woodruff）以及他们进行人类研究的气道临床研究中心 人类受试者招募，表征，研究支气管镜检查和痰的成功记录 归纳以及高质量生物测量的加工，银行，数据库记录和分布 和RNA，以及将分子和细胞测定与安全处理和验证的数据库联系起来 相关的临床数据。