SclerodermaTRANSCLERONCT07256418
Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma
An observational study of Scleroderma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma
- What is being tested?
- Skin samples and Analysis of fibroblasts
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible participants (patients and control participants) will be identified during their usual follow-up consultation.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Bernard BONOTTE, 03.80.29.34.32 ext. +33, Bernard.bonnotte@chu-dijon.fr
About this study
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
- Being tested
- Skin samples, Analysis of fibroblasts
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin samplesProcedure or surgery
- Scleroderma group: skin biopsy for scleroderma patients
- Control group: recovery of resected tissue from patients undergoing plastic, reconstructive and aesthetic surgery.
Analysis of fibroblastsOther
Analysis of samples by RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| scleroderma | People with systemic scleroderma Receives: Procedure: Skin samples; Other: Analysis of fibroblasts | |
| Control | People undergoing plastic, cosmetic and reconstructive surgery Receives: Procedure: Skin samples; Other: Analysis of fibroblasts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start26 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256418
- Sponsor's protocol ID
- BONNOTTE 2025-2
- Acronym
- TRANSCLERO
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma
- ClinicalTrials.gov ID
- NCT07256418
- Acronym / sponsor ID
- TRANSCLERO / BONNOTTE 2025-2
- Conditions
- Scleroderma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scleroderma | – | Procedure: Skin samples, Other: Analysis of fibroblastsPeople with systemic scleroderma |
| Control | – | Procedure: Skin samples, Other: Analysis of fibroblastsPeople undergoing plastic, cosmetic and reconstructive surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants (patients and control participants) will be identified during their usual follow-up consultation.
Key inclusion criteria (6 listed)
- Person who has given written consent
- Person with systemic scleroderma
- Person who has given written consent
- Person undergoing plastic, cosmetic and reconstructive surgery
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin samples* Scleroderma group: skin biopsy for scleroderma patients * Control group: recovery of resected tissue from patients undergoing plastic, reconstructive and aesthetic surgery. | Procedure or surgery | Control, scleroderma |
| Analysis of fibroblastsAnalysis of samples by RNA sequencing | Other | Control, scleroderma |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard BONNOTTE (03.80.29.34.32 ext. +33, Bernard.bonnotte@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genes involved in the various cell activation and signalling pathways (time frame: through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.