Novel Markers of Disease Progression in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease progression
研究概览
简要总结
Study design: A prospective cohort study with a longitudinal design, with several parameters measured serially at baseline and at pre-specified time points during three to five years of clinical observation.
Primary objective: To validate quantitative analysis of lung sounds as a marker of disease progression in a cohort of patients with Interstitial Lung Disease (ILD) via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes (symptoms and quality of life).
Secondary objectives: To determine the prognostic value of quantitative analysis of lung sounds and a series of novel putative biological markers, obtained from peripheral blood and bronchoalveolar lavage, toward poor outcomes (death, categorical decline of % predicted FVC >10%, acute exacerbation or respiratory-related hospitalisations) as compared to more conventional clinical, physiology and radiologic measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ILD, made according to international guidelines where available
- •age between 40 and 90 years
排除标准
- •significant comorbidities or physical impairment that could affect participation
结局指标
主要结局
Disease progression
时间窗: 3 years
Validate quantitative analysis of lung sounds as a marker of disease progression via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes.
次要结局
未报告次要终点
研究者
RICHELDI LUCA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS