Cohort of patients with systemic sclerosis at Brest University Hospital
Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank
This study is collecting health information and samples from adults with systemic sclerosis to see how the disease affects their quality of life, pain, and disability over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT05532865 on ClinicalTrials.gov |
What this trial studies
This observational study involves a prospective cohort of adult patients diagnosed with systemic sclerosis. It aims to collect longitudinal clinical data and biological samples, including blood, stool, and skin swabs for microbiota analysis. Participants will also complete questionnaires assessing their quality of life, pain, and disability. The study is conducted at the reference center for rare autoimmune diseases at Brest University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with systemic sclerosis according to EULAR 2013 criteria.
Not a fit: Patients who are minors, under legal protection, or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of systemic sclerosis and improve patient management through better data and biological insights.
How similar studies have performed: While similar cohort studies have been conducted, this specific approach focusing on systemic sclerosis and microbiota analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1) * Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest. * Patient affiliated to the social security system * Patient having signed a written informed consent. Exclusion Criteria: * Minor * Patient under legal protection (guardianship, curatorship) * Refusal to participate * Patient unable to consent * Pregnant or breastfeeding woman * Hemoglobin (Hb) level \< 7g/dl
Where this trial is running
Brest
- CHRU de Brest — Brest, France (Recruiting)
Study contacts
- Study coordinator: Claire DE MOREUIL
- Email: claire.demoreuil@chu-brest.fr
- Phone: 0033298145303
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.