SPIROMICS Clinical Center

慢性阻塞性肺疾病研究中的亚群和中间结果测量(SPIROMICS)承包商将设计和实施一项临床研究研究，采用广泛的受试者表型和分子指纹分析，以确定慢性阻塞性肺疾病(COPD)患者的亚群，并识别和验证疾病严重程度的替代标记物，这将有助于临床试验的中间结果测量。研究对象将在大约六个临床中心(CCS)进行登记、表型和跟踪。基因组学和信息学中心(GIC)将主要负责为实现研究目标制定科学计划；分析表型和高通量分子数据；运营生物标本储存库；开发生物信息资源；数据管理；对研究提供全面管理和监督；以及传播研究结果。放射学中心将主要负责临床中心的标准化成像方法；建立CT图像数据库；评估和确保CT图像的质量；以及分析CT图像以获得可能指示COPD或其他肺部疾病的存在和/或严重程度的定量测量。

SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) contractors will design and conduct a clinical research study with extensive subject phenotyping and molecular fingerprinting to identify subpopulations of patients with chronic obstructive pulmonary disease (COPD) and to identify and validate surrogate markers of disease severity which will be useful as intermediate outcome measures for clinical trials. Research subjects will be enrolled, phenotyped, and followed at approximately six Clinical Centers (CCs). A Genomics and Informatics Center (GIC) will have primary responsibility for developing a scientific plan for achieving study aims; analyzing phenotypic and high-throughput molecular data; operating a repository of biospecimens; developing bioinformatic resources; data management; providing overall management and oversight of the study; and disseminating study results. The Radiology Center will have primary responsibility for standardizing imaging methods at the Clinical Centers; establishing a repository of CT image data; assessing and assuring quality of CT images; and analyzing CT images to obtain quantitative measures that may indicate the presence and/or severity of COPD or other lung diseases.