The overall goal of the Human Subjects and Data Analysis Core is to provide biologic samples and clinical information from well-defined human subjects to enable each of the scientific projects in the AADCRC to translate their findings to the bedside. The Core and its related activities (designated the Asthma and Airways Translational Research Unit or AATRU) have a long track record of successfully recruiting human subjects and carefully characterizing these subjects with physiological and biological methods. The use of the Core will eliminate duplication of effort regarding subject recruitment, collection of clinical subject data, the performance of specialized procedures such as bronchoscopy with bronchoalveolar lavage, brushings and endobronchial biopsies as well as initial processing of blood, BAL, and biopsy specimens. Biopsies and brushings will be submitted to the Tissue &Cell Processing Core for preparation towards use in the individual Projects. The Core will conduct all clinical studies and provide for subject management throughout all procedures. Accordingly, the Human Subjects and Data Analysis Core aims to oversee: I. Human Subject Recruitment and Characterization. lA. Recruit and characterize mild to severe stable asthmatic subjects and a control group of normal subjects for participation in the AADCRC projects. IB. Maintain the AADCRC clinical database. II. Data Analysis. MA. Provide statistical analysis of data from each of the component projects and assist each project to correlate these findings with clinical data. MB. Provide bioinformatics and data analysis for the projects using high-throughput and large data set approaches, including but not limited to microarray gene expression, RNA sequencing, and multiplex ELISA methods to analyze samples from experimental models and human subjects. Under this approach, the Core will allow for a centralized database for the comparison and correlation of clinical data with biological and pathological endpoints from the scientific projects. This resource sharing will enable critical findings from the AADCRC projects to be translated to the patient with asthma and/or allergic disease.
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