Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

NCT ID: NCT05273138

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic sclerosis patients

Patients fulfilling the ACR/EULAR criteria for systemic sclerosis

Blood sampling and skin biopsy

Intervention Type OTHER

Blood sampling and skin biopsy

Healthy subjects

Blood sampling and skin biopsy

Intervention Type OTHER

Blood sampling and skin biopsy

Interventions

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Blood sampling and skin biopsy

Blood sampling and skin biopsy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Launay, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David Launay, MD,PhD

Role: CONTACT

0320445962

Facility Contacts

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Role: primary

0320445962

Other Identifiers

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2021-A03137-34

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0611

Identifier Type: -

Identifier Source: org_study_id

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