Understanding lung disease progression in systemic sclerosis patients
Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)
This study looks at how lung disease develops over time in people with systemic sclerosis to see if we can better predict its progression and improve treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy, Grand Est) |
| Trial ID | NCT05345795 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the different trajectories of interstitial lung disease (ILD) in patients diagnosed with systemic sclerosis (SSc). By utilizing latent class mixed models, the study will analyze how ILD progresses over time in these patients and how this progression correlates with various characteristics of SSc. The goal is to develop reliable prediction tools that can help stratify the risk of ILD progression, which is crucial for effective management of the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with systemic sclerosis who also have interstitial lung disease confirmed by HRCT chest.
Not a fit: Patients with alternative diagnoses for their lung disease, such as silicosis, sarcoidosis, or lung cancer, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management strategies for patients with systemic sclerosis and interstitial lung disease.
How similar studies have performed: While the specific approach of this study may be novel, other studies have explored similar trajectories in chronic lung diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
Where this trial is running
Vandœuvre-lès-Nancy, Grand Est
- CHU Nancy — Vandœuvre-lès-Nancy, Grand Est, France (Recruiting)
Study contacts
- Study coordinator: Paul DECKER, MD
- Email: p.decker@chru-nancy.fr
- Phone: +33383157240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.