CORE--Clinical

核心--临床

• 批准号: 7394166
• 负责人: Robert J Kaner
• 金额: $ 32.3万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-12 至 2011-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7394166
• 关键词: Alveolar Macrophages; Bronchoscopy; Chest; Chronic Obstructive Airway Disease; Clinical; Clinical Research; Collection; Data; Discipline of Nuclear Medicine; Enrollment; Ensure; Equipment; Gene Expression; Guidelines; Human; Human Subject Research; Individual; Injury; Methodology; Operative Surgical Procedures; Pathologic; Pattern; Phenotype; Physicians; Physiological; Population; Procedures; Protocols documentation; Purpose; Qualifying; Recruitment Activity; Regulatory Affairs; Resources; Sampling; Scanning; Scientist; Screening procedure; Techniques; Time; Work; airway epithelium; clinical phenotype; experience; repaired; research study; response

The purpose of Core A - Clinical Core is to serve as a resource to the 4 clinical projects (1, 2, 4, 5) of the COPD SCCOR. The Clinical Core will assist in: (1) recruiting subjects; (2) screening of subjects to determine suitability for the projects; (3) carefully phenotyping subjects under clearly defined protocols, once they have been enrolled in the projects; (4) obtaining the relevant biologic materials using fiberoptic bronchoscopy; and (5) working with Core B - the Clinical Operations and Regulatory Affairs (CORA) to ensure all of the studies are done with relevant regulatory / protocol guidelines, and to provide ready access to the clinical phenotyping data. The Clinical Core has extensive experience in both the recruitment and screening, as well as clinical phenotyping of various populations used in numerous clinical research studies. In the 9 months precedingthe submission of this current proposal,a total of 137 individuals have already been assessed and phenotyped for COPD-related clinical research studies through the facilities and resources of the Clinical Core. The Core has access to state-of-theart facilities and equipment with which to carry out procedures, including bronchoscopy, quantitative CT chest scans, and nuclear medicine assessments, integral to phenotyping subjects and obtaining high- quality biologic materials in sufficient quantities for each project. It is staffed by highly qualified physician-scientists with extensive experience in safely conducting bronchoscopies on human research subjects, using previously established methodology for collection of human airway epithelium and alveolar macrophages. As part of these methodologies, the Clinical Core will implement techniques it has more recently established and validated for procurement of airway epithelium from the small airways, as well as obtaining samples over time for assessment of the gene expression pattern in response to brush injury to the airway epithelium, mimicking repair processeswhich may result in the pathologic and physiologic derangements noted in COPD. The Core will devote equal resourcesto Projects 1,2,4 and 5.

核心 A - 临床核心的目的是作为 4 个临床项目（1、2、4、5）的资源 慢性阻塞性肺病 SCCOR。临床核心将协助：（1）招募受试者； (2) 受试者筛选 确定项目的适用性； (3) 根据明确定义的方案仔细对受试者进行表型分析， 一旦他们注册了项目； (4) 获取相关生物材料 纤维支气管镜检查； (5) 与核心 B 合作 - 临床运营和监管 事务（CORA）以确保所有研究均按照相关监管/方案指南进行，以及 提供对临床表型数据的便捷访问。临床核心在以下方面拥有丰富的经验 招募和筛选，以及用于不同人群的临床表型分析 大量的临床研究。在提交当前提案之前的 9 个月内， 总共 137 名个体已经接受了 COPD 相关临床研究的评估和表型分析 通过临床核心的设施和资源进行研究。核心可以访问最先进的 进行手术的设施和设备，包括支气管镜检查、定量 CT 胸部扫描和核医学评估是对受试者进行表型分型和获得高 为每个项目提供足够数量的优质生物材料。它拥有高素质的员工 在安全进行人体研究支气管镜检查方面拥有丰富经验的医师科学家 受试者，使用先前建立的方法收集人类气道上皮和 肺泡巨噬细胞。作为这些方法的一部分，临床核心将实施其技术 最近建立并验证了从小的气道上皮的采购 气道，以及随着时间的推移获取样本以评估基因表达模式 对气道上皮刷伤的反应，模仿修复过程，这可能会导致 COPD 中注意到的病理和生理紊乱。核心将投入同等资源 项目 1、2、4 和 5。