Clinical Core

临床核心

• 批准号: 7160727
• 负责人: Raed A. Dweik
• 金额: $ 27.15万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7160727
• 关键词: biopsy; blood tests; breath tests; bronchoscopy; diagnostic respiratory lavage; human subject; immunologic skin test; lung; medical outreach /case finding; medical records; respiratory function; sample collection; tissue resource /registry; urinalysis

The Clinical Core (Core B) component of this PPG will provide the clinical expertise and organization necessary to accomplish the studies involving human subjects that are proposed in the projects within this PPG. The core will be responsible for subject recruitment and communication, clinical specimen collection, subject characterization through clinical data acquisition and subject follow-up. The Clinical Core will interact intimately with the Tissue Processing and Cell Culture Core C to ensure distribution of clinical samples and data to program investigators. In this capacity, the clinical core will function as a collective resource to the PPG that will facilitate accomplishment of each of the three projects and also promote interaction between the different projects to glean the most information from valuable clinical samples. Following recruitment, the core will use a variety of clinical parameters to divide subjects into four well-defined subgroups: 1) nonallergic, non-asthmatic normal volunteers, 2) allergic non-asthmatics, 3) non-allergic asthmatics, and 4) allergic asthmatics. The volunteers will undergo a comprehensive evaluation including pulmonary function testing, allergy skin testing, blood testing and exhaled gas measurements. Select volunteers will also undergo outpatient flexible fiberoptic bronchoscopy. Through this procedure the core will obtain airway specimens including mucosal brushings, bronchoalveolar lavage fluid, and endobronchial biopsy tissue. These specimens will allow the core to assess parameters of airway inflammation and will be further processed by the Tissue Processing and Cell Culture Core C for use by all three PPG projects. For all of the studies within the PPG utilizing human subject samples, the clinical core will be responsible for assuring subject safety, data confidentiality and full regulatory compliance.

该 PPG 的临床核心（核心 B）部分将提供临床专业知识和组织 完成本项目中提出的涉及人类受试者的研究所必需的 PPG。核心将负责受试者招募和沟通、临床标本采集、 通过临床数据采集和受试者随访来表征受试者。临床核心将互动 与组织处理和细胞培养核心 C 密切合作，确保临床样本的分配和 向计划调查人员提供数据。以此身份，临床核心将作为集体资源发挥作用 PPG 将促进这三个项目中每一个项目的完成，并促进之间的互动 不同的项目从有价值的临床样本中收集最多的信息。招募后， 核心将使用各种临床参数将受试者分为四个明确定义的亚组：1）非过敏， 非哮喘正常志愿者，2) 过敏性非哮喘患者，3) 非过敏性哮喘患者，以及 4) 过敏性哮喘。志愿者将接受包括肺功能在内的综合评估 测试、皮肤过敏测试、血液测试和呼出气体测量。选定的志愿者还将 门诊接受可弯曲纤维支气管镜检查。通过此程序，核心将获得气道 标本包括粘膜刷检、支气管肺泡灌洗液和支气管内活检组织。 这些样本将使核心能够评估气道炎症的参数，并将进一步 由组织处理和细胞培养核心 C 进行处理，供所有三个 PPG 项目使用。对于所有的 PPG 内利用人类受试者样本进行的研究，临床核心将负责确保 主体安全、数据机密性和完全合规性。