Clinical Characterization and Biorepository Core

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ORDRCC Clinical Characterization and Biorepository Core Project Summary The Oklahoma Rheumatic Disease Research Cores Center (ORDRCC) is focused on mechanistically-driven, patient-oriented investigation that improves understanding of pathogenesis, prediction, prevention and precision therapy for patients with rheumatic diseases. The Clinical Characterization and Biorepository Core (CCBC) serves as the heart of the ORDRCC and underpins major rheumatic disease collaborations, NIH- sponsored trials and other investigator initiated clinical trials with a CAP-certified biorepository. With this ORDRCC support, the CCBC maintains longitudinal and cross-sectional sample collections with >58,400 rheumatic disease patients, unaffected family members and unrelated controls. This immense and unparalleled resource has supported groundbreaking findings in systemic lupus erythematosus (SLE), Sjogren’s syndrome, undifferentiated connective tissue disease (UCTD), rheumatoid arthritis (RA) and osteoarthritis (OA), while also supporting the career development and research programs of well over 200 investigators. A critical aim of the CCBC is to enable ORDRCC investigators to perform rigorous and clinically meaningful research. Thus, the CCBC provides Center Investigators, Junior Center Investigators, Scholars and Collaborators, each from either within or outside Oklahoma, with clinical research services, including training, regulatory assistance, protocol development, subject identification and recruitment, sample procurement, and detailed clinical evaluations, disease activity and therapeutic information. The CAP-certified OMRF Biorepository also processes and manages samples for CCBC investigators and provides samples from our extensive and well-phenotyped collections, with extensive corresponding clinical and experimental data. In addition, the Biorepository is expanding the SLE, RA and related disease collections with new longitudinal data, patient reported outcomes and real-time disease monitoring. The CCBC will also expand enrollment in the new UCTD, OA and autoimmune rheumatic disease pregnancy collections, and will process, store and manage new samples for all collections. To facilitate mechanistic studies as our investigators forge into precision medicine for rheumatic diseases, the CCBC is expanding capabilities in clinical and translational research informatics. Using the custom Autoimmune Disease Institute Data System with an associated TranSMART platform, the CCBC Translational Clinical Research Informatics group will curate regulatory, clinical, demographic, therapeutic, and sample tracking information for each subject along with partnered experimental information on the same patients/samples. All new data generated on CCBC samples by the Human Phenotyping Core will be integrated with current data to create high-dimensional datasets. The CCBC will perform advanced modeling with these data to identify molecularly similar patient subsets, which can be used to reduce heterogeneity in mechanistic studies, identify directed therapeutics, and develop clinical trials for patients with similar pathway involvement, ultimately improving trial outcomes and precision therapy in rheumatic diseases.