CORE--Clinical

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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.