Clinical Characterization and Biorepository Core

临床特征和生物样本库核心

基本信息

批准号：
10251964
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/10251964
关键词：
Address American Autoantibodies Autoimmune Autoimmune Diseases 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 autoimmune rheumatologic disease 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 临床特征和生物样本库核心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、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的临床特征和生物库核心。 (CCBC) 是 ORDRCC 的核心，并支持主要风湿病合作、NIH- 赞助的试验和其他研究者利用 CAP 认证的生物样本库发起了临床试验。 ORDRCC 支持，CCBC 维护着超过 58,400 个纵向和横截面样本采集风湿病患者、未受影响的家庭成员和无关的控制者，这是巨大且无与伦比的。该资源支持了系统性红斑狼疮 (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 多名研究人员的职业发展和研究项目是该组织的一个重要目标。 CCBC 旨在使 ORDRCC 研究人员能够进行严格且具有临床意义的研究。 CCBC 提供中心调查员、初级中心调查员、学者和合作者，每个人都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、监管援助、方案开发、受试者识别和招募、样本采购以及详细的临床评估，经 CAP 认证的 OMRF 生物存储库还可以处理和处理疾病活动和治疗信息。为 CCBC 研究人员管理样本，并提供来自我们广泛且表型良好的样本此外，生物样本库还拥有大量相应的临床和实验数据。利用新的纵向数据、患者报告的结果扩大 SLE、RA 和相关疾病的收集 CCBC 还将扩大新的 UCTD、OA 和实时疾病监测的注册人数。自身免疫性风湿病妊娠收集，并将为所有人处理、存储和管理新样本随着我们的研究人员致力于风湿病的精准医学，促进机制研究。疾病，CCBC 正在利用该技术扩展临床和转化研究信息学的能力。定制自身免疫性疾病研究所数据系统以及相关的 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、治疗和每个受试者的样本跟踪信息以及同一受试者的合作实验信息人类表型分析核心在 CCBC 样本上生成的所有新数据都将被 CCBC 将与当前数据集成以创建高维数据集。利用这些数据来识别分子相似的患者子集，这可用于减少异质性机制研究，确定定向疗法，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准治疗。