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
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

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)