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.

核心B：此核心通过三个功能支持本应用程序中的项目。这些是：功能1）协调PAH患者和对照组的招募，临床评估参与者并进行样本收集；功能2）建立和维护生物循环库并分发其资源（血清，等离子体，循环细胞，培养的成纤维细胞，DNA，RNA，RNA，银行组织样品） 向哥伦比亚的合作者和其他NIH资助的调查员；功能3）促进数据分析，尤其是项目1、2和3中的人类数据。特发性PAH患者将在很大程度上汲取我们的肺血管疾病中心，这是一个临床中心，该中心拥有近450名参考患者，并已成功参与了过度参与在过去十年中，20个国家临床试验。控制措施将来自范德比尔特一般临床研究中心银行（ResearchMatch.com）和家庭内部。我们使用一个 国家标本和调查公司，用于异地收集标本。 HPAH患者还将通过与经营哥伦比亚pH组的pH遗传学成分的Wendy Chung博士进行的持续合作从哥伦比亚大学招募。在功能2中，将在肺循环基因组的实验室中产生，加工和储存在功能2中，将血液，尿液，细胞，DNA，RNA和组织产生 中心，Vanderbilt DNA资源核心和肺部分裂的实验室。整个集合的管理将由专门的人员使用全面的REDCAP数据库来完成。我们的数据库中有超过2000名受试者的历史，包括用于遗传和家庭数据的后代软件，可以可靠，准确地移动DNA，RNA，数据和材料。功能3是 在项目1和2中创建的数据分析。我们的流行病学家和统计学家协助了实验的开发和设计，他们将成为整个PPG的统计协调员，包括动力，样本量，估算，结果测量，数据检查，数据检查，数据检查和质量控制，根据数据集和假设的不同，适用的生物稳定测试。因此统计支持完全 集成到设计，行为和分析中。