Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis, Interstitial Lung Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)
Overview
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.
Primary outcome measures
- FVC change over time [Time frame: at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis]
Secondary outcome measures (1)
- DLCO change over time [Time frame: at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Nancy — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT05345795 · 2022PI045