Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling and skin biopsy.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other Blood sampling and skin biopsy
Blood sampling and skin biopsy
Primary outcome measures
- Single cell RNAseq transcriptomic analysis of skin [Time frame: At inclusion]
Secondary outcome measures (1)
- Single cell RNAseq transcriptomic analysis of the whole blood [Time frame: At inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Hop Claude Huriez Chu Lille — Lille
Identifiers
NCT: NCT05273138 · 2021_0611 · 2021-A03137-34