Clinical Subject and Biospecimen Core

临床受试者和生物样本核心

• 批准号: 10636503
• 负责人: Nirav Rati Bhakta
• 金额: $ 38.8万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10636503
• 关键词: Airway Disease; Applications Grants; Area; Asthma; Biological; Biological Specimen Banks; British Columbia; Bronchoscopy; Cells; Cellular Assay; Chronic Obstructive Pulmonary Disease; Clinical; Clinical Data; Clinical Research; Collection; Cryopreservation; Cytometry; DNA; Data; Databases; Enrollment; Ensure; Epithelial Cells; Epithelium; Functional disorder; Gene Expression Profiling; Goals; Harvest; Human; Image; Immune; Individual; Institutional Review Boards; Link; Lung; Lung diseases; Measures; Messenger RNA; Methods; MicroRNAs; Molecular; Mucous body substance; National Institute of Allergy and Infectious Disease; Participant; Pathology; Pathway interactions; Performance; Process; Proteins; Protocols documentation; RNA; Registries; Regulation; Research; Research Personnel; Resources; Sampling; Secure; Source; Specimen; Structure of parenchyma of lung; System; Tissue Banks; Translational Research; Universities; Work; X-Ray Computed Tomography; airway epithelium; bronchial epithelium; cell bank; clinical phenotype; clinically significant; data submission; experience; experimental study; genomic data; human subject; human tissue; insight; novel; recruit; single-cell RNA sequencing; success; tissue registry

CLINICAL CORE SUMMARY The Clinical Subject and Biospecimen Processing and Analysis Core will provide a core resource that will be required for each aim of both projects. The core will 1) conduct unique processing and novel analysis of inflated lung specimens from individuals with and without asthma across areas with and without mucus plugs, 2) recruit, characterize, and sample airway tissue from human subjects in a clinical study, and 3) process and distribute biospecimens and data to the projects. Dr. Nirav Bhakta (Core Director), along with a team consisting of a research coordinator, a technician, and a programmer analyst, have considerable experience in all aspects of recruiting human subjects for translational research protocols, and collecting and banking high-quality biospecimens. Co-investigator Dr. Tillie Hackett directs a large lung tissue biospecimen bank, The James Hogg Lung Registry at University of British Columbia, and has developed state of the art methods for detailed molecular characterization of lung tissue. Using the resources of this highly experienced and well-resourced group, the core will have three aims. Aim 1 is to identify immune and airway epithelial features associated with asthma and mucus plugging in banked lung tissue; this includes single-cell, imaging mass cytometry and gene expression profiling to measure proteins, mRNAs, and miRNAs in lungs from individuals with fatal and non-fatal asthma and COPD and controls without airway disease. This data will support both projects. Aim 2 is to collect high quality biospecimens from a new bronchoscopy study using systems and methods which ensure compliance with federal and local regulations. This will support studies in both projects that require freshly harvested cells. Aim 3 is to provide specialized processing, secure storage, and timely distribution of human biospecimens and data to both projects and coordinate deposition of data into the publicly accessible NIAID ImmPort database. In addition to providing very high quality clinical phenotyping and biological specimens from human donors and subjects, this core will process and distribute epithelial brushings from bronchoscopy and from donor lungs for subsequent culture, cryopreservation, and single-cell RNA sequencing. Dr. Bhakta and the UCSF Airway Clinical Research Center in which he conducts human studies have a track record of success in human subjects recruitment, characterization, and research bronchoscopy, and in the processing, banking, database recording and distribution of high-quality biospecimens and RNA, as well as linking of molecular and cellular assays to safely handled and validated databases of associated clinical data. Research conducted by Dr. Hackett and colleagues from The James Hogg Lung Registry is notable for the methods of inflating donor lungs and imaging them with CT scanning to enable the comparison of not only the pathology but also molecular (RNA, DNA, protein) profiles of diseased lungs compared to healthy donor controls. 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.

临床核心摘要 临床主题和生物测量处理和分析核心将提供核心资源 每个项目的每个目标都需要。核心意愿1）进行独特的处理和对夸大的新分析 肺部有或没有粘液塞的区域的患者和没有哮喘的人的肺标本，2）招募， 在临床研究中从人类受试者中表征和采样气道组织，3）处理和分布 生物测量和项目的数据。 Nirav Bhakta博士（核心主任），以及一个由 研究协调员，技术人员和程序员分析师在各个方面都有丰富的经验 招募人类主题进行转化研究方案，并收集和银行高质量 生物测量。共同投资者蒂莉·哈克特（Tillie Hackett）博士指导詹姆斯·霍格（James Hogg 不列颠哥伦比亚省大学的肺注册表，并开发了用于详细分子的最先进的方法 肺组织的表征。利用这个经验丰富且资源丰富的群体的资源， 核心将有三个目标。目标1是确定与哮喘和哮喘和气道上皮特征 粘液塞入储存的肺组织；这包括单细胞，成像质量细胞术和基因表达 分析可测量致命性和非致命性哮喘患者肺中的蛋白质，mRNA和miRNA COPD和没有气道疾病的控制。这些数据将支持两个项目。目标2是收集高质量 使用系统和方法的新支气管镜研究中的生物测量，以确保符合符合 联邦和地方法规。这将支持在需要新鲜收获的细胞的两个项目中的研究。目标3 是提供专业的处理，安全的存储以及人类生物测量和数据的及时分配到 两个项目和数据将数据坐在公共访问的NIAID Immport数据库中。此外 为人类捐助者和受试者提供非常高质量的临床表型和生物标本， 该核心将从支气管镜检查和供体肺部处理和分发上皮刷 培养，冷冻保存和单细胞RNA测序。 Bhakta博士和UCSF气道临床研究 他进行人类研究的中心在人类受试者招聘方面的成功记录， 表征和研究支气管镜检查，以及在处理，银行业务，数据库记录和 高质量的生物测量和RNA的分布，以及分子和细胞测定的连接到安全 处理和验证的相关临床数据数据库。 Hackett博士及其同事进行的研究 来自詹姆斯·霍格肺注册中心的著名方法是使供体肺膨胀并用成像成像的方法 CT扫描不仅可以比较病理学，还可以比较分子（RNA，DNA，蛋白质）谱。 与健康的供体对照相比，患病的肺部。鉴于人类研究是 此赠款应用程序，该核心对于每个项目的成功绩效至关重要 其中提出的科学研究的临床意义。