Clinical and Statistical Support Core/Loyd

核心B：此核心通过三个功能支持此应用程序中的项目。这些是：职能1）协调PAH患者和对照组的招募，对入组者进行临床评价并进行样本采集;职能2）建立并维护生物样本库，并将其资源（血清、血浆、循环细胞、培养的成纤维细胞、DNA、RNA、库存组织样本）分配给项目1、2和3，以及 为哥伦比亚的合作者和其他NIH资助的研究者提供服务;功能3）促进数据分析，特别是项目1、2和3中的人类数据。特发性PAH患者将主要来自我们的肺血管疾病中心，该临床中心拥有近450例参考患者，并在过去十年中成功参与了20多项国家临床试验。对照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，用于非现场标本采集。HPAH患者也将通过与负责哥伦比亚PH组PH遗传学部分的Wendy Chung博士的持续合作从哥伦比亚大学招募。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、处理和储存 中心，范德比尔特DNA资源核心和肺科实验室。整个收集的管理将由专门人员使用全面的REDCap数据库进行。我们的数据库中有超过2000个受试者的历史，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 分析主要在项目1和项目2中创建的数据。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帮助，他们将是整个PPG的统计协调员，包括把握度、样本量、估计值、结局指标、数据检查和质量控制，以及根据数据集和假设应用适当的生物统计学检验。因此，统计支持充分 整合到设计、实施和分析中。

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.