NCT03670576Unknown不适用
It's Not JUST Idiopathic Pulmonary Fibrosis Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 24
- 主要终点
- Overall Survival
研究概览
简要总结
Study of progression of fibrosis in ILD
详细描述
The overall aims of this study are
- Identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology
- To prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including RA-UIP, Asbestosis, Chronic Hypersensitivity Pneumonitis and Unclassifiable fibrotic lung disease
- Investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression
- Prospectively evaluate longitudinal disease behaviour in patients with non IPF-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Participating in an interventional clinic trial
- •Asymptomatic Interstitial Lung Abnormalities (ILA) and normal lung function.
- •Change in clinical phenotype from initial radiological diagnosis to screening
- •Acute Hypersensitivity Pneumonitis.
- •Participants who do not possess a smartphone or have a valid email address (necessary for the home FVC readings)
结局指标
主要结局
Overall Survival
时间窗: 10 years
All patients will be tagged at the central NHS registry in order to provide mortality data. For this reason we will need to keep our datasets active for up to 10 years to allow a complete mortality analysis.
Disease Progression
时间窗: Within 12 months
Disease progression defined as \>10% relative decline in FVC (using either hospital spirometry or home hand held spirometry) or death within 12 months.
次要结局
- Serum and Plasma Biomarkers(Baseline, 3 months, 12 months, 24 months)
研究者
研究点 (24)
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