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

August 2, 2023 updated by: Paul DECKER, MD, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Grand Est
      • Vandoeuvre-lès-nancy, Grand Est, France, 54500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with systemic sclerosis-interstitial lung disease

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SSc-ILD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FVC change over time
Time Frame: 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)
at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLCO change over time
Time Frame: 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)
at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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