Clinical and Statistical Support Core/Loyd

临床和统计支持核心/Loyd

• 批准号: 8534250
• 负责人: Ivan M Robbins
• 金额: $ 43.2万
• 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/8534250
• 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：该核心通过三个功能支持此应用程序中的项目。它们是： 功能 1) 协调 PAH 患者和对照的招募，对招募者进行临床评估并进行样本收集；功能 2) 建立和维护生物样本库，并将其资源（血清、血浆、循环细胞、培养成纤维细胞、DNA、RNA、库存组织样本）分配给项目 1、2 和 3 哥伦比亚大学的合作者和其他 NIH 资助的研究人员；功能3）促进数据分析，特别是项目1、2和3中的人体数据。特发性PAH患者将主要来自我们的肺血管疾病中心，该中心拥有近450名参考患者，并在过去十年中成功参加了20多项国家临床试验。控制措施将来自范德比尔特综合临床研究中心银行 (ResearchMatch.com) 和家庭内部。我们使用一个 国家标本和调查公司，负责标本的异地采集。哥伦比亚大学还将通过与负责哥伦比亚 PH 小组 PH 遗传学部分的 Wendy Chung 博士持续合作，从哥伦比亚大学招募 HPAH 患者。在功能 2 中，血液、尿液、成纤维细胞、细胞、DNA、RNA 和组织将在肺循环基因组学实验室中生成、处理和存储 中心、范德比尔特 DNA 资源核心和肺科实验室。整个藏品的管理将由专门人员使用综合的 REDCap 数据库来完成。我们的数据库中有超过 2000 个受试者的历史记录，包括用于遗传和家庭数据的 Progeny 软件，并且可以可靠、准确地移动 DNA、RNA、数据和材料。函数3是 主要对项目 1 和 2 中创建的数据进行分析。实验的开发和设计得到了我们的流行病学家和统计学家的协助，他们将成为整个 PPG 的统计协调员，包括动力、样本量、估计、结果测量、数据检查和质量控制、根据数据集和假设应用适当的生物统计测试。因此统计支持是充分的 融入到设计、实施和分析中。