Scleroderma (Limited and Diffuse)NCT07015060
Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis
A study testing cutaneous biospy in people with Scleroderma (Limited and Diffuse), run by Université Catholique de Louvain.
Trial summary
Identify rare variants in candidate genes and pathways identified in familial SSc, in patients with sporadic SSc. Perform (spatial) transcriptomic and proteomic analyses of affected skin from patients with and without cutaneous fibrosis, for the patterns and levels of expression/activation of candidate genes and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Scleroderma (Limited and Diffuse)
- What is being tested?
- cutaneous biospy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Mar 2031
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with one of the following:
- Limited SSc
- Limited cutaneous SSc
- Diffuse cutaneous SSc
- Patients followed regularly in consultations at CUSL.
- Patients between ages 18-80.
Who cannot join
- Other (co-occurring) autoimmune/autoinflammatory disease
- Pregnancy
- Participants with temporary or definitive disabilities to give consent
- Participants unable to sign or read the inform consent form
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Identify rare variants in candidate genes and pathways identified in familial SSc, in patients with sporadic SSc.
Perform (spatial) transcriptomic and proteomic analyses of affected skin from patients with and without cutaneous fibrosis, for the patterns and levels of expression/activation of candidate genes and pathways.
Test for dysregulation of expression/activation of candidate genes and pathways in live cells isolated from the blood and skin biopsy of patients, and for the impact of these dysregulations on cell appearance, behavior and function.
- Conditions
- Scleroderma (Limited and Diffuse)
- Being tested
- cutaneous biospy
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cutaneous biospyProcedure or surgery
cutaneous biospy
| Study group | Role | What they receive |
|---|---|---|
| PathSSc | Other | Not described Receives: Procedure: cutaneous biospy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy)
Genetic analyses in affected skin from patients (Next Generation sequencing, (single cell) RNASeq, real time qPCR)
Measured: Through the entire study, approximately during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma (Limited and Diffuse)Studies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nisha Limaye, PhD, Study director, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015060
- Sponsor's protocol ID
- PathSSC
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07015060
- Acronym / sponsor ID
- PathSSC
- Conditions
- Scleroderma (Limited and Diffuse)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 11 Jun 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.
Identify rare variants in candidate genes and pathways identified in familial SSc, in patients with sporadic SSc.
Perform (spatial) transcriptomic and proteomic analyses of affected skin from patients with and without cutaneous fibrosis, for the patterns and levels of expression/activation of candidate genes and pathways.
Test for dysregulation of expression/activation of candidate genes and pathways in live cells isolated from the blood and skin biopsy of patients, and for the impact of these dysregulations on cell appearance, behavior and function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PathSSc | Other | Procedure: cutaneous biospy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with one of the following:
- Patients followed regularly in consultations at CUSL.
- Patients between ages 18-80.
Key exclusion criteria (4 listed)
- Other (co-occurring) autoimmune/autoinflammatory disease
- Pregnancy
- Participants with temporary or definitive disabilities to give consent
- Participants unable to sign or read the inform consent form
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 |
|---|---|---|
| cutaneous biospycutaneous biospy | Procedure or surgery | PathSSc |
Primary outcome
Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy)
Time frame: Through the entire study, approximately during 5 years
Genetic analyses in affected skin from patients (Next Generation sequencing, (single cell) RNASeq, real time qPCR)
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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Nisha Limaye, PhD study director
Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A study testing cutaneous biospy in people with Scleroderma (Limited and Diffuse), run by Université Catholique de Louvain.
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 4 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: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Farah Tamirou, Pr (+32 2 674 53 87, farah.tamirou@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy) (time frame: Through the entire study, approximately during 5 years). 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 11 Jun 2025.