Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05345795

Acronym

SCLEROPIDEVOL

Enrollment

600

Registered

2022-04-26

Start date

2023-05-01

Completion date

2025-09-01

Last updated

2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Systemic Sclerosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
FVC change over time	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)

Secondary

Measure	Time frame	Description
DLCO change over time	at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis	evaluation of %predicted DLCO values over time using latent class mixed models (LCMM)

Countries

France

Contacts

Primary ContactPaul DECKER, MD

p.decker@chru-nancy.fr+33383157240

Outcome results