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NCT Number: NCT05345795

Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nancy

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

Location status: Recruiting

Location contact

Paul DECKER, MD

CONTACT

[email protected]

+33383157240

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Paul DECKER, MD

CONTACT

[email protected]

+33383157240

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: SCLEROPIDEVOL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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