Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- FVC change over time
研究概览
简要总结
Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Disease course in SSc-ILD is highly variable: patients can experience stable disease, slow or fast progression. Prevention of ILD progression now represents a key objective of SSc-ILD management. The understanding of the course and patterns of SSc-ILD progression is necessary, as reliable prediction tools that allow the stratification of the risk of progression. We aimed to identify the longitudinal trajectories of ILD in SSc patients using latent class mixed models and to examine their associations with SSc characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
- •Patients with interstitial lung disease on HRCT chest
- •Patients with PFT at ILD diagnosis and at least 1 PFT evaluation during follow-up
排除标准
- •Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
结局指标
主要结局
FVC change over time
时间窗: at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis
evaluation of %predicted FVC values over time using latent class mixed models (LCMM)
次要结局
- DLCO change over time(at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis)
研究者
Paul DECKER, MD
Principal Investigator
Central Hospital, Nancy, France