Clinical Characterization and Biorepository Core

临床特征和生物样本库核心

基本信息

批准号：
10016170
负责人：
ELIZA F CHAKRAVARTY
金额：
$ 30.67万
依托单位：
OKLAHOMA MEDICAL RESEARCH FOUNDATION
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-07 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10016170
关键词：
Address American Autoantibodies Autoimmune Diseases Autoimmune Process Certification Cherokee Indian Classification Clinical Clinical Data Clinical Research Clinical Trials Clinical Trials Design Collaborations Collection Connective Tissue Diseases Custom Data Data Reporting Data Set Degenerative polyarthritis Disease Doctor of Philosophy Educational workshop Enrollment Evaluation Family member Funding Genetic Genomics Genus Capra Grant Heart Heterogeneity Human Human Resources Human Subject Research Immune Informatics Information Systems Infrastructure Institutes Institutional Review Boards Investigation Investments Mediator of activation protein Modeling Molecular Molecular Profiling Monitor NCI Scholars Program Oklahoma Outcome Participant Pathogenesis Pathologist Pathway interactions Patient Outcomes Assessments Patient Recruitments Patients Phenotype Precision therapeutics Pregnancy Prevention therapy Process Protocols documentation Publications Registries Reproducibility Research Research Personnel Research Support Resources Rheumatism Rheumatoid Arthritis Sampling Sampling Studies Science Secure Services Sjogren&apos s Syndrome System Systemic Lupus Erythematosus Therapeutic Time Training Translational Research Undifferentiated United States National Institutes of Health Work base biobank career career development clinical center cohort college experimental study high dimensionality human subject improved individual patient molecular phenotype novel patient oriented patient subsets phenotypic data precision medicine predictive modeling programs protocol development real time monitoring recruit repository research and development research clinical testing response sample collection

项目摘要

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.

ORDRCC临床表征和生物座核项目摘要俄克拉荷马州风湿病研究核心中心（ORDRCC）专注于机械驱动的，以患者为导向的调查，以提高对发病机理，预测，预防和风湿性疾病患者的精确治疗。临床表征和生物座核（CCBC）是ORDRCC和基础风湿性疾病合作的核心，NIH- 赞助的试验和其他研究者使用帽额认证的生物座启动了临床试验。与此 ORDRCC支持，CCBC保持纵向和横截面样品收集> 58,400 风湿病患者，未受影响的家庭成员和无关的对照。这个巨大而无与伦比的资源支持全身性狼疮红斑（SLE）的开创性发现，Sjogren综合征，未分化的连接组织疾病（UCTD），类风湿关节炎（RA）和骨关节炎（OA），同时也是支持200多个研究人员的职业发展和研究计划。一个关键目的 CCBC将使ORDRCC调查人员能够进行严格且具有临床意义的研究。那， CCBC为中心调查员，初级中心调查员，学者和合作者提供，每一个俄克拉荷马州内部或外部，提供临床研究服务，包括培训，监管援助，协议开发，主题识别和招聘，样本采购以及详细的临床评估，疾病活动和治疗信息。 Cap认证的OMRF BiorePository还处理管理CCBC调查人员的样本，并提供我们广泛且良好型的样品收集，具有广泛的相应临床和实验数据。此外，生物座是使用新的纵向数据扩展SLE，RA和相关疾病收集，患者报告的结果和实时疾病监测。 CCBC还将扩大新的UCTD，OA和自身免疫性风湿病妊娠收集，并将为所有人处理，存储和管理新样本收藏。为了促进机械研究，我们的研究人员锻炼了风湿性的精确医学疾病，CCBC正在扩大临床和翻译研究信息的能力。使用具有相关跨Mart平台的自定义自身免疫性疾病研究所数据系统CCBC 翻译临床研究信息学小组将策划监管，临床，人口统计，治疗和每个主题的示例跟踪信息以及相同的合作实验信息患者/样品。由人类表型核心在CCBC样品上生成的所有新数据将是与当前数据集成以创建高维数据集。 CCBC将执行高级建模使用这些数据来识别分子相似的患者子集，可用于降低异质性机械研究，识别定向治疗并为具有相似途径的患者开发临床试验参与，最终改善了风湿性疾病中的试验结果和精确疗法。