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NCT05482607 Clinical Trial

Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease

Systemic Sclerosis Clinical Trial

— LUNGSCLEROCT  

Official title:
Unsupervised Clustering Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05482607
Other study ID # 2022PI105
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date October 1, 2024

Study information
Verified date August 2023
Source Central Hospital, Nancy, France
Contact Paul DECKER, MD
Phone +33383157240
Email p.decker@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. Interstitial lung disease (ILD) concerns almost 50 % of SSc patients and represents the main cause of mortality. SSc-ILD is variable: from limited forms (with asymptomatic patients) to extensive lesions. Disease course in SSc-ILD is also highly variable: patients can experience stable disease, slow or fast progression. Investigators performed unsupervised clustering analysis to classify SSc-ILD according to elementary radiological lesions on HRCT scan.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with systemic sclerosis according to 2013 ACR/EULAR criteria - Patients with interstitial lung disease on HRCT chest Exclusion Criteria: - Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Central Hospital Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary HRCT scan variables HRCT scan variables included in hierarchical agglomerative clustering (HAC) analysis baseline (J0)
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