Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma (TRANSCLERO)

January 28, 2026 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
scleroderma
People with systemic scleroderma
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
Control
People undergoing plastic, cosmetic and reconstructive surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genes involved in the various cell activation and signalling pathways
Time Frame: through study completion, an average of 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BONNOTTE 2025-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Scleroderma

Clinical Trials on Skin samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe