NCT04265144 Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre
| NCT ID | NCT04265144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Scleroderma |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-06-08 |
| Primary Completion | 2034-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2020-06-08 with a primary completion date of 2034-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to conducting quality research on this disease remains the development of well-documented patient cohorts with reliable biological samples. The main objective of this cohort is to study the natural progression of SSc in a cohort of patients followed over 5 years.
Eligibility 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
Contact & Investigator
Marie-Elise TRUCHETET, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT04265144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scleroderma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04265144 currently recruiting?
Yes, NCT04265144 is actively recruiting participants. Contact the research team at marie-elise.truchetet@chu-bordeaux.fr for enrollment information.
Where is the NCT04265144 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT04265144 clinical trial?
NCT04265144 is sponsored by University Hospital, Bordeaux. The principal investigator is Marie-Elise TRUCHETET, MD, PhD at University Hospital, Bordeaux. The trial plans to enroll 500 participants.