Clinical Characterization and Biorepository Core

ORR CC临床表征和生物储存核心项目总结 俄克拉荷马州风湿病研究核心中心（ORDRCC）专注于机械驱动， 以患者为导向的调查，提高对发病机制，预测，预防和 风湿性疾病患者的精准治疗。临床表征和生物储存核心 （CCBC）作为ORDRCC的心脏，并支持主要的风湿性疾病合作，NIH- 申办的试验和其他研究者发起的临床试验与CAP认证的生物储存库。与此 在国家生物多样性研究中心的支持下，CCBC保持着纵向和横向的样本收集， 风湿性疾病患者，未受影响的家庭成员和无关的对照。这个巨大的和无与伦比的 资源支持系统性红斑狼疮（SLE），干燥综合征， 未分化结缔组织病（UCTD）、类风湿性关节炎（RA）和骨关节炎（OA），同时还 支持200多名调查员的职业发展和研究方案。一个关键的目标， CCBC旨在使ORR CC研究者能够进行严格且有临床意义的研究。因此 CCBC提供中心研究者、初级中心研究者、学者和合作者，分别来自 在俄克拉荷马州内外，提供临床研究服务，包括培训、监管协助、协议 开发、受试者识别和招募、样本采集和详细的临床评价， 疾病活动和治疗信息。CAP认证的OMRF生物储存库还处理和 为CCBC研究人员管理样本，并提供来自我们广泛和良好表型的样本。 收集了大量相应的临床和实验数据。此外，生物储存库是 通过新的纵向数据、患者报告的结局，扩展SLE、RA和相关疾病的收集 实时疾病监测。CCBC还将扩大新的UCTD，OA和 自身免疫性风湿病妊娠收集，并将处理，存储和管理所有新的样本 收藏.促进机制研究，因为我们的研究人员正在打造风湿性关节炎的精确药物 疾病，CCBC正在扩大临床和转化研究信息学的能力。使用 自定义自身免疫疾病研究所数据系统与相关的TranSmart平台，CCBC 转化临床研究信息学小组将策划监管，临床，人口统计学，治疗和 每个受试者的样本跟踪信息沿着以及关于相同受试者的合作实验信息 患者/样本。人类表型分析核心对CCBC样本生成的所有新数据将 与当前数据集成以创建高维数据集。CCBC将进行高级建模 利用这些数据来识别分子相似的患者亚群，这可用于减少 机制研究，确定定向治疗，并为具有相似途径的患者开展临床试验 参与，最终改善风湿性疾病的试验结果和精确治疗。

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.