Cohort of patients with systemic sclerosis
Official title: Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases
Run by University Hospital, Bordeaux · NCT04265144 · Data updated 2026-11-12
This study is trying to gather information from patients with systemic sclerosis over five years to better understand how the disease develops and find ways to improve treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Status | Recruiting |
| Started | June 8, 2020 |
| Main results expected | June 2034 |
| Study ends | June 2034 |
| Registry record updated | September 4, 2025 |
| Trial ID | NCT04265144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old diagnosed with systemic sclerosis or very early systemic sclerosis.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or under legal protection will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to create a well-documented cohort of patients with systemic sclerosis (SSc) to better understand the natural progression of the disease over a five-year period. It involves collecting biological samples, including blood and biopsy specimens, to analyze the pathophysiology of SSc, which is characterized by vascular involvement and fibrosis. The study will focus on patients meeting specific criteria for systemic sclerosis, including those with early-stage symptoms. The findings may help to improve the understanding of SSc and potentially lead to future treatment options.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of systemic sclerosis and pave the way for the development of effective treatments.
How similar studies have gone: While this approach is part of ongoing efforts to understand systemic sclerosis, it builds on previous studies like the VISS study, indicating a collaborative effort in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old * Patient with systemic scleroderma according to the ACR/EULAR 2013 criteria, or with a " very early systemic sclerosis " defined by the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity). * Person affiliated or benefiting from a social security scheme. * Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research) Exclusion Criteria: * Pregnant or breastfeeding woman * Patient under guardianship, curatorship or any other legal protection regime
Where it's running
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CHU de Bordeaux - service de rhumatologie
Bordeaux, France Recruiting
Study contacts
- Principal investigator: Marie-Elise TRUCHETET, MD, PhD — University Hospital, Bordeaux
- Study coordinator: Marie-Elise TRUCHETET, MD, PhD
- Email: marie-elise.truchetet@chu-bordeaux.fr
- Phone: 05.56.79.55.56
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.