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

August 2, 2023 updated by: Paul DECKER, MD, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with systemic sclerosis-interstitial lung disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
SSc-ILD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRCT scan variables
Time Frame: baseline (J0)
HRCT scan variables included in hierarchical agglomerative clustering (HAC) analysis
baseline (J0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Paul Decker, MD, CHU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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