Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

NCT05345795 | Recruiting

• 1 other identifier: 2022PI045
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• FVC change over time

  evaluation of %predicted FVC values over time using latent class mixed models (LCMM)

  at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis

Secondary Outcomes (1)

• DLCO change over time

  at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis

Study Arms (1)

SSc-ILD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic sclerosis-interstitial lung disease

You may qualify if:

• 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

You may not qualify if:

• Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHU Nancy

Vandœuvre-lès-Nancy, Grand Est, 54500, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Paul DECKER, MD

CONTACT

+33383157240; p.decker@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 26, 2022
• Study Start: May 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

FR (1)