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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05482607
Collaborator
(none)
100
Enrollment
5.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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. We performed unsupervised clustering analysis to classify SSc-ILD according to elementary radiological lesions on HRCT scan.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Unsupervised Clustering Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    SSc-ILD patients

    Outcome Measures

    Primary Outcome Measures

    1. HRCT scan variables [baseline (J0)]

      HRCT scan variables included in hierarchical agglomerative clustering (HAC) analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paul DECKER, MD, MD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05482607
    Other Study ID Numbers:
    • 2022PI105
    First Posted:
    Aug 1, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Interstitial
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Sclerosis

    Study Results

    No Results Posted as of Aug 1, 2022