The goal of the Tissue Handling and Repository Core (Core B) is to provide services to optimize the collection and analysis of matched clinical data and biospecimens obtained for the Research Projects, Pilot Project and Clinical Components. Specifically, the Core will seek to enhance quality of clinical data collections, define recruitment protocols, improve efficiencies through common biospecimens processing, and develop a common, healthy control sample pool for recall for subsequent functional studies.
Three specific aims are proposed. First, we propose to enhance clinical data collections. Web-based clinical data collection instruments will be developed, tested and analyzed for Research Studies and Clinical Trials. The Core will work with Principal Investigators to develop protocols which will enhance uniform, complete and high quality data collection between sites. It is anticipated that for each project, rapid development time and investigator-control will be desired, and that modest-sized collections will be accrued. Second, we propose to develop and apply a workflow methodology for biospecimen tracking and central specimen processing. Workflow methodology will be developed and applied to divide, track and link biospecimens collections through the Principal Investigator, the Tissue Handling and Repository Core, and Ancillary (e.g. Pathology, Flow cytometry) Laboratories. Processing of serum, DMA, and cryopreservation of peripheral blood mononuclear cells will be performed for subjects with Type 1 diabetes (T1DM), primary Sjogren's syndrome (pSS), inflammatory bowel disease (IBD), and healthy control subjects. Third, we propose to develop a redrawable healthy control and patient repository stratified on genotypes of interest. Enhancement of a common healthy control and dataset is proposed for the purposes of recruiting and recalling appropriate gender, age and ancestry-matched controls for mechanistic studies using peripheral blood leukocytes.
Primary Sjogren's syndrome, Type 1 diabetes, and inflammatory bowel disease are chronic inflammatory diseases affecting more than 3 million Americans and represent significant public health priorities. Development of improved medical therapies for these disorders are needed. This Core will support both scientific studies to assess altered immune function and clinical trials to test new therapies.
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