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

U

University Hospital, Lille

Status

Enrolling

Conditions

Systemic Sclerosis

Treatments

Other: Blood sampling and skin biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT05273138
2021-A03137-34 (Other Identifier)
2021_0611

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

David Launay, MD,PhD

Data sourced from clinicaltrials.gov

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