Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

Recruiting

• Conditions: Systemic Sclerosis
• Interventions: Other: Blood sampling and skin biopsy

• Registration Number: NCT05273138
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-10
• Study Start: 2022-06-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-22
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systemic sclerosis patients	Blood sampling and skin biopsy	Patients fulfilling the ACR/EULAR criteria for systemic sclerosis
Healthy subjects	Blood sampling and skin biopsy	-

Primary Outcome Measures

Name	Time	Method
Single cell RNAseq transcriptomic analysis of skin	At inclusion

Secondary Outcome Measures

Name	Time	Method
Single cell RNAseq transcriptomic analysis of the whole blood	At inclusion

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France