Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

NCT05273138 | Recruiting

• 2 other identifiers: 2021_06112021-A03137-34
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis; Fibrosis, fibroblasts.; Fibroblasts.; Immune system.; B lymphocytes.

Outcome Measures

Primary Outcomes (1)

• Single cell RNAseq transcriptomic analysis of skin

  At inclusion

Secondary Outcomes (1)

• Single cell RNAseq transcriptomic analysis of the whole blood

  At inclusion

Study Arms (2)

Systemic sclerosis patients

Patients fulfilling the ACR/EULAR criteria for systemic sclerosis

Other: Blood sampling and skin biopsy

Healthy subjects

Other: Blood sampling and skin biopsy

Interventions

Blood sampling and skin biopsy OTHER

Blood sampling and skin biopsy

Healthy subjects; Systemic sclerosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the University Hospital of Lille

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, skin

MeSH Terms

Conditions

Scleroderma, Systemic; Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Launay, MD,PhD

CONTACT

0320445962; david.launay@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)