SUBPOPULATIONS AND INTERMEDIATE OUTCOME MEASURES IN COPD STUDY (SPIROMICS): BRON

COPD 研究中的亚群和中间结果指标（SPIROMICS）：BRON

• 批准号: 8352887
• 负责人: EUGENE BLEECKER
• 金额: $ 13.59万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8352887
• 关键词: Bioinformatics; Bronchoscopy; Chronic Obstructive Airway Disease; Clinical; Clinical Research; Clinical Trials; Contractor; Data; Enrollment; Genomics; Image; Immunophenotyping; Informatics; Lung diseases; Measures; Molecular; Molecular Profiling; Observational Study; Outcome Measure; Patients; Phase; Phenotype; Radiology Specialty; Research Subjects; Resources; Severities; Severity of illness; Surrogate Markers; data management; design; imaging modality; repository; research study

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.

在COPD研究（SPIROMICS）中，承包商将设计并开展一项临床研究，其中包括广泛的受试者表型和分子指纹识别，以确定慢性阻塞性肺疾病（COPD）患者的亚群，并确定和验证疾病严重程度的替代标记，这些标记将作为临床试验的中间结果测量。研究对象将入组，分型，并在大约六个临床中心（CCs）进行随访。基因组学和信息学中心（GIC）将主要负责制定科学计划以实现研究目标；分析表型和高通量分子数据；操作生物标本库；开发生物信息学资源；数据管理;全面管理和监督研究工作；并传播研究结果。放射学中心将主要负责规范临床中心的成像方法；建立CT图像数据库；评估和保证CT图像质量；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。