Patient Resource Core

患者资源核心

基本信息

批准号：
9133282
负责人：
Edwin Allan Smith
金额：
$ 30.36万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至 2018-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9133282
关键词：
Academic Medical Centers African American Architecture Biological Biopsy Blood Blood Cells Bronchoalveolar Lavage Fluid Cardiac Catheterization Procedures Cells Clinic Clinic Visits Clinical Clinical Data Clinical Research Clinical Trials Collaborations Collection Communities Community Physician Complex Computerized Medical Record DNA Data Data Quality Data Set Databases Diagnosis Disease Echocardiography Electronics Enrollment Environment Epigenetic Process Fibroblasts Funding Future Genes Genetic Goals Grant Health Image Informatics Instruction Island Knowledge Laboratories Link Longitudinal Studies Lupus Medical Genetics Notification Pathway interactions Patients Persons Pilot Projects Population Procedures Process RNA Rare Diseases Recruitment Activity Reporting Research Research Infrastructure Research Personnel Research Project Grants Resources Rheumatism Rheumatology Risk Factors SCTR gene Sampling Scleroderma Sea Secure Serum Sierra Leone Site Skin Specimen System Systemic Lupus Erythematosus Time Tissues Translating Translational Research Urine base biobank biomedical informatics clinical data warehouse community partnership cost effective data acquisition design electronic data gene environment interaction genetic information human subject improved information gathering innovation meetings member novel open source prevent programs sample collection social success text searching tool volunteer

项目摘要

PROJECT SUMMARY To study complex genetic and gene-environment interactions in heterogeneous diseases such as scleroderma (SSc) and systemic lupus erythematosus (SLE) as proposed in Projects 1 and 2, large numbers of patients and well characterized samples and genetic data must be accessible for analysis in a single database. Samples and clinical data must be of high quality to reduce variability. The acquisition of data and samples must be cost-effective to be feasible. The purpose of the Patient Resource Core is to recruit and retain a well characterized group of persons with the diagnosis of either SLE or SSc or healthy controls for clinical and biological studies. This population is necessary to carry out the aims of Projects 1 and 2 and future projects initiated by the research base and other future investigators. Subjects will be recruited from MUSC Clinics. The core will develop, in collaboration with the SCTR Biomedical Informatics Core, a recruitment tool that identifies, from the Clinical Data Warehouse patients with the diagnosis of SLE or Sac prior to the clinic visit. Subjects will also be recruited from lay organizations and from community physicians carrying for such patients. A full time study coordinator will recruit and retain these subjects and gather information from them. The collected information will include demographic, social, environmental, genetic, and clinical data. Innovations will include obtaining data electronically from the MUSC Clinical Data Warehouse and piloting a text-mining program to retrieve items from electronic narrative reports (e.g. progress notes, imaging studies, echocardiography, cardiac catheterization reports, and biopsy results) for a recruiting tool. Data will be entered into longitudinal REDCap electronic databases (an existing SLE database will be moved to REDCap and a newly constructed SSc database will be created) so that these can be retrieved easily by the Project 1 and 2 investigators and the research base. Biologic samples (serum, urine, cells, DNA, RNA, and tissue) obtained from the SLE and SSc subjects will be stored using nationally recognized standard operating procedures^ These specimens will be electronically entered and tracked to be readily retrievable for studies. The biologic; specimens will be linked to the information in the REDCap and electronic medical record databases for seamless queries in an i2b2 workbench. This type of integrated data will accelerate the progress of gene and gene-environment studies proposed in Projects 1 and 2.

项目摘要为了研究异质性疾病（例如硬皮病（SSC））和全身性狼疮的复杂遗传和基因环境相互作用，如项目1和2所述，必须在单个数据库中访问大量的患者，特征性良好的样本和遗传数据。样品和临床数据必须具有高质量的质量才能降低变异性。数据和样品的获取必须具有成本效益才能可行。患者资源核心的目的是招募和保留诊断为SLE或SSC或健康对照组的良好特征的人群，以进行临床和生物学研究。该人群对于执行项目1和2的目标以及研究基础和其他未来研究人员发起的未来项目是必要的。受试者将从MUSC诊所招募。核心将与SCTR生物医学信息学核心合作发展从临床数据仓库患者进行诊断，可以在诊所诊断之前识别招聘工具。也将从外行组织和携带此类患者的社区医生招募受试者。全日制学习协调员将招募和保留这些主题，并从中收集信息。收集的信息将包括人口，社会，环境，遗传和临床数据。创新将包括从MUSC临床数据仓库以电子方式获取数据，并试行一项文本挖掘程序，以从电子叙事报告（例如进度注释，影像学研究，超声心动图，心脏导管插入术报告和活检结果）中检索项目，以供招聘工具）。数据将输入到纵向REDCAP电子数据库中（现有的SLE数据库将移至REDCAP，并创建新构建的SSC数据库），以便项目1和2的研究人员和研究基础可以轻松地检索这些数据库。从SLE和SSC受试者获得的生物样品（血清，尿液，细胞，DNA，RNA和组织）将使用全国认可的标准操作程序存储^这些标本将被电子输入并跟踪以进行研究。生物学；标本将链接到I2B2工作台中无缝查询的REDCAP和电子病历数据库中的信息。这种综合数据将加速项目1和2中提出的基因和基因环境研究的进展。