Cohort of patients with systemic sclerosis
Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT04265144 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with systemic sclerosis or very early systemic sclerosis.
Not a fit: Patients who are pregnant, breastfeeding, or under legal protection will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bordeaux
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.