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, and the collection and processing of biospecimens from these subjects. Recruiting human subjects for translational research protocols requires well-developed systems to ensure successful subject recruitment and the collection of high quality biospecimens from well-characterized human subjects. Dr. Nirav Bhakta (Core Director), Dr. Prescott Woodruff (Associate Core Director; also Associate Director of the UCSF Airway Clinical Research Center), along with a team consisting of a research coordinator, a technician, 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.
Aim 1 is to recruit and enroll asthmatic subjects for the 1-year longitudinal study with bronchoscopy and sputum induction protocols to support Projects 1 and 2; this includes the management of IRB-related approvals and other regulatory paperwork for human research.
Aim 2 is to collect high quality biospecimens from this new study using systems and methods which ensure compliance with federal and local regulations.
Aim 3 is to bank and create database entries for biospecimens requested from three already-completed studies: 1) CLAVIER, a longitudinal bronchoscopy study with subjects randomized to lebrikizumab or placebo, 2) RITA, an 8-week longitudinal study with subjects randomized to inhaled corticosteroid (ICS) or no ICS, and 3) baseline bronchoscopy visit in the multi-center NIH/NHLBI-funded Severe Asthma Research Program (SARP).
Aim 4 is to provide specialized processing, secure storage, and timely distribution of the human biospecimens collected from the clinical studies. In addition to providing very high quality clinical phenotyping and biological specimens from human subjects, this core will perform specialized 1) processing of induced sputum samples to achieve multiple Project-specific aims from the same sample, and 2) processing of epithelial brushings for subsequent culture, cryopreservation, single-cell RNA sequencing, and bulk cell RNA sequencing. For the bulk cell RNA sequencing of epithelial brushings, the core will perform RNA extractions and assessments of RNA quantity and quality. Given that human studies are an integral component of this grant application, this core will be critical for the successful performance of each Project and for establishing the clinical significance of the scientific studies proposed within them. Drs. Bhakta and Woodruff, and the Airway Clinical Research Center in which they conduct human studies, have a track record of success in humans subjects recruitment, characterization, research bronchoscopy and sputum induction, and in the processing, banking, database recording and distribution of high-quality biospecimens and RNA, as well as linking molecular and cellular assays to safely handled and validated databases of associated clinical data.
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