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Recruiting NCT07256418

Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma

Observational Scleroderma

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: Skin samples, Analysis of fibroblasts.
Who it may be relevant to
Registry conditions: Scleroderma. 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 →

Overview

Scleroderma is a complex connective tissue disease involving three interconnected pathophysiological axes: vascular hyperactivity and remodelling, immune system dysfunction and over-activation of fibroblasts at the origin of the fibrosis process in the skin and organs. Given that this pathology occurs preferentially in mature subjects, it is possible to suggest a potential inductive role for senescent fibroblasts, which would be responsible for activating and/or maintaining the immune response and systemic inflammation. Our hypothesis is that fibroblasts play a predominant role in the genesis and maintenance of this pathology.

Interventions

  • Procedure Skin samples
    * Scleroderma group: skin biopsy for scleroderma patients * Control group: recovery of resected tissue from patients undergoing plastic, reconstructive and aesthetic surgery.
  • Other Analysis of fibroblasts
    Analysis of samples by RNA sequencing

Primary outcome measures

  • genes involved in the various cell activation and signalling pathways [Time frame: through study completion, an average of 12 months]

Eligibility criteria

Inclusion criteria

FOR PATIENTS WITH SCLERODERMA :

  • Person who has given written consent
  • Person with systemic scleroderma

FOR CONTROL PARTICIPANTS :

  • Person who has given written consent
  • Person undergoing plastic, cosmetic and reconstructive surgery

Exclusion criteria

FOR PATIENTS WITH SCLERODERMA :

  • Person not affiliated to or not benefiting from a social security scheme
  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a legal protection measure
  • An adult who is incapable or unable to give consent
  • Minors

FOR CONTROLLED PARTICIPANTS :

  • Person suffering from a chronic disease or under chronic treatment for autoimmune, inflammatory or dermatological diseases
  • Person not affiliated to or not benefiting from a social security scheme
  • Person under legal protection (curatorship, guardianship)
  • Person subject to a legal protection measure
  • An adult who is incapable or unable to give consent
  • Minors

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
Cohort

Study locations

France · 1 center
  • CHU Dijon Bourgogne — Dijon

Identifiers

NCT: NCT07256418 · BONNOTTE 2025-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗