SPIRIOMICS

COPD 研究中的亚群和中间结果测量 (SPIROMICS) 承包商将设计和开展一项临床研究，其中包括广泛的受试者表型分析和分子指纹分析，以识别慢性阻塞性肺疾病 (COPD) 患者的亚群，并识别和验证疾病严重程度的替代标志物，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 (CC) 进行登记、表型分析和随访。基因组学和信息学中心（GIC）将主要负责制定实现研究目标的科学计划；分析表型和高通量分子数据；运营生物样本库；开发生物信息资源；数据管理；提供研究的全面管理和监督；并传播研究结果。放射中心将主要负责临床中心成像方法的标准化；建立CT图像数据存储库；评估和保证 CT 图像的质量；分析 CT 图像以获得可表明 COPD 或其他肺部疾病的存在和/或严重程度的定量测量值。

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.