Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis (Skin-SSC)

December 18, 2025 updated by: University Hospital, Lille
The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. The heterogeneity of fibroblast profiles, observed in other fibrosing pathologies, has never been thoroughly explored in the skin of SSc patients. The immune system, and in particular B lymphocytes, plays a central role in the pathophysiology of SSc. The interactions between B lymphocytes and the cells responsible for excess collagen production, i.e. fibroblasts, are not fully elucidated The main objective is to analyze the heterogeneity of fibroblasts and infiltrating immune cells as well as their molecular signature in the skin of patients with SSc

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

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

  • France
      • Lille, France, 59037
        • Recruiting
        • Hop Claude Huriez Chu Lille
        • Contact:

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients from the University Hospital of Lille

Description

Inclusion Criteria:

  • Man or woman over 18 years of age
  • With a systemic sclerosis meeting the ACR-EULAR 2013 criteria Having signed an informed consent
  • Being insured

Exclusion Criteria:

  • Syndrome of overlap with another connective tissue disease according to the international diagnostic criteria
  • Immunosuppressive treatment within 12 months
  • Dosage of current corticosteroid therapy ≥10mg/d
  • Protected minors or adults
  • Pregnant or breastfeeding women
  • Deprived of their liberty
  • Persons in emergency situations
  • Persons who have refused or are unable to give informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
Other: Blood sampling and skin biopsy
Blood sampling and skin biopsy
Systemic sclerosis patients
Patients fulfilling the ACR/EULAR criteria for systemic sclerosis
Other: Blood sampling and skin biopsy
Blood sampling and skin biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Single cell RNAseq transcriptomic analysis of skin
Time Frame: At inclusion
At inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Single cell RNAseq transcriptomic analysis of the whole blood
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

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)

June 8, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_0611
  • 2021-A03137-34 (Other Identifier: ID-RCB number,ANSM)

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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