Host-microbiome Interactions in the Quest for Fibrosing ILD Biomarkers That Rule Acceleration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Discover biomarkers in progressive pulmonary fibrosis
研究概览
简要总结
FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies.
Other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18-80 years
- •People undergoing blood collection, lung biopsy and/or BAL as part of their diagnostic workup
- •Willingness to undergo the follow-up protocol evaluations
- •Treatment-naïve for disease-modifying drugs
- •An HRCT scan performed within the last 12 months showing ≥10% fibrosis extent of the lungs
排除标准
- •People who cannot give informed consent
- •Pregnancy
结局指标
主要结局
Discover biomarkers in progressive pulmonary fibrosis
时间窗: 36 months
Characterization of blood and tissue transcriptional signatures of progression and acute exacerbations, and validate findings at the protein expression level, which could be easily converted for clinical use as biomarkers.
次要结局
- Change in microbiome profile in progressive pulmonary fibrosis(24 months)