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NCT Number: NCT07256418

Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin samples

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

Analysis of fibroblasts

Other

Analysis of samples by RNA sequencing

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard BONNOTTE

CONTACT

[email protected]

03.80.29.34.32 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: TRANSCLERO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 1, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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