Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma

NCT ID: NCT07256418

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-26

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scleroderma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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scleroderma

People with systemic scleroderma

Skin samples

Intervention Type 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

Intervention Type OTHER

Analysis of samples by RNA sequencing

Control

People undergoing plastic, cosmetic and reconstructive surgery

Skin samples

Intervention Type 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

Intervention Type OTHER

Analysis of samples by RNA sequencing

Interventions

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Skin samples

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

Intervention Type PROCEDURE

Analysis of fibroblasts

Analysis of samples by RNA sequencing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bernard BONNOTTE

Role: CONTACT

03.80.29.34.32 ext. +33

Facility Contacts

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Bernard BONOTTE

Role: primary

03.80.29.34.32 ext. +33

Other Identifiers

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BONNOTTE 2025-2

Identifier Type: -

Identifier Source: org_study_id

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