Clinical and Statistical Support Core/Loyd

临床和统计支持核心/Loyd

• 批准号: 8401046
• 负责人: Ivan M Robbins
• 金额: $ 47.41万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8401046
• 关键词: BMPR2 gene; Biopsy; Blood; Blood Pressure; Calendar; Cell Culture Techniques; Cells; Cessation of life; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Collection; Communication; Computer software; Country; DNA; Data; Data Analyses; Data Collection; Data Quality; Data Set; Databases; Defect; Development; Disease; Doctor of Philosophy; Enrollment; Epidemiologist; Family; Fibroblasts; Funding; Genetic; Genomics; Heart failure; Hormonal; Human; Human Resources; Ice; Instruction; Internet; Intervention; Laboratories; Location; Logic; Lung; Maintenance; Metabolic; Methods; Molecular; Monitor; Online Systems; Outcome; Outcome Measure; Patient Recruitments; Patients; Phenotype; Plasma; Procedures; Process; Program Research Project Grants; Protocols documentation; Pulmonary Circulation; Quality Control; RNA; Recording of previous events; Recruitment Activity; Reporting; Research Personnel; Research Project Grants; Resources; Review Committee; Role; Running; Safety; Sample Size; Sampling; Schedule; Secure; Signal Transduction; Skin; Specimen; Stream; Surveys; Testing; Tissue Sample; Tissues; United States National Institutes of Health; Universities; Urine; Vascular Diseases; base; cohort; data acquisition; data management; database design; design; effective therapy; family genetics; human data; medical examination; mutation carrier; patient population; pulmonary arterial hypertension; reconstitution; repository; research study; sample collection; tool

CORE B: This Core supports the Projects in this application through three functions. These are: Function 1) to coordinate recruitment of PAH patients and controls, clinically evaluate enrollees and conduct sample collection; Function 2) establish and maintain a biospecimen repository and distribute its resources (serum, plasma, circulating cells, cultured fibroblasts, DNA, RNA, banked tissue samples) to Projects 1, 2 and 3 and to collaborators at Columbia and for other NIH funded investigators; Function 3) facilitate analysis of data, especially human data in Projects 1, 2 and 3. The idiopathic PAH patients will largely be drawn from our Center for Pulmonary Vascular Disease, a clinical center that has nearly 450 reference patients and has successfully participated in over 20 national clinical trials over the last decade. Controls will come from the Vanderbilt General Clinical Research Center bank (ResearchMatch.com) and from within families. We use a national specimen and survey company for offsite collection of specimens. HPAH patients will also be recruited from Columbia University through an ongoing collaboration with Dr. Wendy Chung who runs the PH genetics component of the Columbia PH group. In Function 2, blood, urine, fibroblasts, cells, DNA, RNA and tissue will be generated, processed and stored in the laboratories of the Pulmonary Circulation Genomics Center, the Vanderbilt DNA Resource Core and the laboratories of the Pulmonary Division. Management of the entire collection will be done by dedicated personnel using the comprehensive REDCap data base. We have a history of over 2 thousand total subjects in our database, including the Progeny Software used for genetic and family data, and can move DNA, RNA, data and materials reliably and accurately. Function 3 is the analysis of data created largely in Projects 1 and 2. The development and design of experiments has been aided by our Epidemiologist and Statistician who will be the statistical coordinator for the entire PPG, including powering, sample size, estimates, outcome measures, data check and quality control, application of appropriate biostatlstical tests depending on data sets and hypotheses. Thus statistical support is fully integrated into the design, conduct and analysis.

CORE B：这个CORE通过三个功能支持这个应用程序中的项目。功能1)协调PAH患者和对照组的招募，临床评估入组者并进行样本采集；功能2)建立和维护生物标本库，并将其资源（血清、血浆、循环细胞、培养成纤维细胞、DNA、RNA、储存组织样本）分配给项目1、2和3