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RecruitingNCT07256418TRANSCLEROUpdated Jan 29, 2026

Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma

An observational study in Scleroderma, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Scleroderma

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03

In context

Scleroderma, Diffuse

310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.

This study's planned enrollment of 60 is below the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.

Browse Scleroderma, Diffuse studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureSkin samples

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

  • OtherAnalysis of fibroblasts

    Analysis of samples by RNA sequencing

06

What researchers measure

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.

    Time frame: through study completion, an average of 12 months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07256418
Responsible party
Sponsor
First posted
Dec 1, 2025
Start date
Jan 26, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 29, 2026

Study contacts

Bernard BONNOTTE
Contact
Bernard.bonnotte@chu-dijon.fr
03.80.29.34.32 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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