The Clinical Subject and Biospecimen Core will provide a core resource for the recruitment and characterization of human subjects, the completion of the clinical studies, the collection and processing of biospecimens from these subjects, and measurement of key molecular and cellular biomarkers that will be used in systematic phenotyping of ILl3- and IL-17 driven inflammation across the projects. Dr Prescott Woodruff (Associate director of the UCSF-Airway Clinical Research Center), along with a team consisting of a research coordinator, two technicians, and a programmer analyst, have considerable experience in all aspects of these systems. Using the resources of this highly experienced and well-resourced group, the core will have four aims: (i) To recruit and enroll asthmatic subjects for the allergen challenge protocol to support the proposed projects; (ii) To collect high quality biospecimens from this allergen challenge study and 2 other ongoing clinical studies using systems and methods which ensure compliance with federal and local regulations; (iii) To provide specialized processing, secure storage, and timely distribution ofthe human biospecimens collected from the clinical studies (iv) To establish standardized assessment of IL13- and IL-17 phenotype to subjects enrolled in the clinical studies through analysis of airway epithelial gene expression, immunohistochemistry and flow cytometry.
By providing very high quality molecular phenotyping and biological specimens from human subjects, this core will be critical for the successful performance of each Project and for establishing the clinical significance ofthe scientific studies proposed within them.
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