Systemic SclerodermaSCLERONCT07343115
Familial Systemic Scleroderma
An observational study of Systemic Scleroderma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Studying familial forms of systemic scleroderma offers several advantages: 1. To better understand the pathophysiology of a complex autoimmune disease based on "extreme" cases (familial forms); 2. To identify potential molecular markers predictive of disease progression; 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Scleroderma
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2025to 2 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects diagnosed with systemic scleroderma by a clinician
Who may be able to join
- Adult subjects (≥ 18 years of age)
- Subjects diagnosed with systemic scleroderma by a clinician (including limited, diffuse, and sine scleroderma SSc, as well as overlap syndromes with myositis) and meeting at least the VEDOSS criteria: Raynaud's phenomenon + 1 other criterion from among: sausage fingers, antinuclear antibodies, scleroderma-specific antibodies (anti-centromere, anti-RNApolIII, anti-ScL70), capillaroscopic abnormalities
- At least one first-degree relative with systemic scleroderma meeting the same criteria
Who cannot join
- Subject who has expressed opposition to participating in the study
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
Service de Médecine interne et Immunologie clinique - CHU de Strasbourg - France
Strasbourg, 67091
Aurélien GUFFROY, MD, 33 3 69 5512 23, aurelien.guffroy@chru-strasbourg.fr
Aurélien GUFFROY, MD
About this study
Studying familial forms of systemic scleroderma offers several advantages:
- To better understand the pathophysiology of a complex autoimmune disease based on "extreme" cases (familial forms);
- To identify potential molecular markers predictive of disease progression;
- To identify potential pathophysiological targets for developing new therapies, particularly relevant in severe and refractory forms of the disease.
- Conditions
- Systemic Scleroderma
- Keywords
- Systemic Scleroderma, Familial Systemic Scleroderma, Autoimmune disease
- Medical subject headings
- Scleroderma, Systemic, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical characteristics of patients with familial systemic scleroderma
The clinical presentation describes how the disease manifests in patients:
the symptoms, their severity, and their progression.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343115
- Sponsor's protocol ID
- 9820
- Acronym
- SCLERO
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT07343115
- Acronym / sponsor ID
- SCLERO / 9820
- Conditions
- Systemic Scleroderma
- Keywords
- Systemic Scleroderma, Familial Systemic Scleroderma, Autoimmune disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
Studying familial forms of systemic scleroderma offers several advantages:
- To better understand the pathophysiology of a complex autoimmune disease based on "extreme" cases (familial forms);
- To identify potential molecular markers predictive of disease progression;
- To identify potential pathophysiological targets for developing new therapies, particularly relevant in severe and refractory forms of the disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects diagnosed with systemic scleroderma by a clinician
Key inclusion criteria (3 listed)
- Adult subjects (≥ 18 years of age)
- Subjects diagnosed with systemic scleroderma by a clinician (including limited, diffuse, and sine scleroderma SSc, as well as overlap syndromes with myositis) and meeting at least the VEDOSS criteria: Raynaud's phenomenon + 1 other criterion from among: sausage fingers, antinuclear antibodies, scleroderma-specific antibodies (anti-centromere, anti-RNApolIII, anti-ScL70), capillaroscopic abnormalities
- At least one first-degree relative with systemic scleroderma meeting the same criteria
Key exclusion criteria (1 listed)
- Subject who has expressed opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the clinical characteristics of patients with familial systemic scleroderma
Time frame: Up to 12 months
The clinical presentation describes how the disease manifests in patients: the symptoms, their severity, and their progression.
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 15 Jan 2026.
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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.
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 Systemic Scleroderma, run by University Hospital, Strasbourg, France 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 3 inclusion and 1 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 15 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 Aurélien GUFFROY, MD (33 3 69 5512 23, aurelien.guffroy@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the clinical characteristics of patients with familial systemic scleroderma (time frame: Up to 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 15 Jan 2026.