Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma

NCT07256418 | Recruiting

• 1 other identifier: BONNOTTE 2025-2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

• genes involved in the various cell activation and signalling pathways

  number and type of genes involved in different cell activation and signalling pathways, including senescence, which will be differentially expressed in fibroblasts from the skin of control participants and those from the skin of subjects with SSc.

  through study completion, an average of 12 months

Study Arms (2)

scleroderma

People with systemic scleroderma

Procedure: Skin samples; Other: Analysis of fibroblasts

Control

People undergoing plastic, cosmetic and reconstructive surgery

Procedure: Skin samples; Other: Analysis of fibroblasts

Interventions

Skin samples PROCEDURE

* Scleroderma group: skin biopsy for scleroderma patients * Control group: recovery of resected tissue from patients undergoing plastic, reconstructive and aesthetic surgery.

Control; scleroderma

Analysis of fibroblasts OTHER

Analysis of samples by RNA sequencing

Control; scleroderma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants (patients and control participants) will be identified during their usual follow-up consultation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Bernard BONNOTTE

CONTACT

03.80.29.34.32; Bernard.bonnotte@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FR (1)