Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

NCT ID: NCT05345795

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SSc-ILD patients

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Paul DECKER, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Nancy

Vandœuvre-lès-Nancy, Grand Est, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Paul DECKER, MD

Role: CONTACT

+33383157240

Facility Contacts

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Paul DECKER, MD

Role: primary

+33383157240

Other Identifiers

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2022PI045

Identifier Type: -

Identifier Source: org_study_id

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