NCT05482607

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

July 29, 2022

Last Update Submit

August 26, 2024

Conditions

Systemic SclerosisInterstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • HRCT scan variables

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

    baseline (J0)

Study Arms (1)

SSc-ILD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with systemic sclerosis-interstitial lung disease

You may qualify if:

  • Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
  • Patients with interstitial lung disease on HRCT chest

You may not qualify if:

  • Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Nancy, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, SystemicLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • Paul Decker, MD

    CHU NANCY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul DECKER, MD

CONTACT

+33383157240p.decker@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 1, 2022

Study Start

January 1, 2023

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

FR(1)