Clinical Characterization and Biorepository Core

ORDRCC临床特征和生物库核心项目总结 俄克拉荷马州风湿病研究核心中心(ORDRCC)专注于机械驱动、 以患者为中心的调查，提高对发病机制、预测、预防和治疗的了解 风湿病患者的精准治疗。临床特征和生物信息库核心 (CCBC)是ORDRCC的心脏，并支持主要风湿病合作，NIH- 赞助试验和其他研究人员使用CAP认证的生物信息库启动了临床试验。有了这个 ORDRCC支持，CCBC与58,400一起维护纵向和横断面样本收集 风湿病患者、未受影响的家庭成员和非亲属对照。这一巨大而无与伦比的 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多名调查人员的职业发展和研究计划。一个关键的目标是 CCBC是为了使ORDRCC的研究人员能够进行严格和有临床意义的研究。因此， CCBC提供中心调查员、初级中心调查员、学者和合作者，每个人来自 在俄克拉荷马州境内或境外提供临床研究服务，包括培训、监管协助、方案 开发、受试者确定和招募、样本采购和详细的临床评估， 疾病活动和治疗信息。CAP认证的OMRF生物库还处理和 为CCBC调查人员管理样本，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，生物库是 通过新的纵向数据、患者报告的结果扩展SLE、RA和相关疾病集合 和实时疾病监测。CCBC还将扩大新的UCTD、OA和 自身免疫性风湿性疾病妊娠收集，并将为所有人处理、存储和管理新的样本 收藏。在我们的研究人员致力于治疗风湿病的精准药物之际，促进机制研究 在疾病方面，CCBC正在扩大临床和转化性研究信息学的能力。使用 自定义自身免疫性疾病研究所数据系统与相关的TranSMART平台CCBC 翻译临床研究信息学小组将管理监管、临床、人口统计学、治疗和 每个受试者的样品跟踪信息以及关于同一样品的合作实验信息 病人/样本。人类表型核心在CCBC样本上产生的所有新数据将是 与当前数据集成以创建高维数据集。CCBC将执行高级建模 利用这些数据来识别分子上相似的患者亚群，这可以用来减少 机制研究，确定定向治疗方法，并为具有类似途径的患者开发临床试验 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.