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Recruiting Not applicable

Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre

NCT04265144 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-06-08
Last updated
2025-09-04

Condition(s) studied

SclerodermaSystemic Sclerosis

Investigational drug(s) / intervention(s)

Blood samples →BiopsyBronchoalveolar samplesBiopsy

Blood samples: 62 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Biopsy: Skin biopsies only for volunteers among patients

Bronchoalveolar samples: 50 ml of bronchoalveolar samples if pulmonary flare requires this type of exploration only for volunteers among patients

Biopsy: Digestives biopsies if requires this type of exploration in the standard of care only for volunteers among patients

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change of the main clinical characteristics of scleroderma patients — At baseline (Day 0) and 60 months after baseline
    Worsening of the SSc according to the onset of a renal crisis (according to arterial hypertension \> 150/85 mm Hg ), a pulmonary arterial hypertension (identified with a right heart catheterization), or an interstitial lung disease (identified with a chest CT-scan).

Trial sites (1)

FacilityCityRegionStatus
CHU de Bordeaux - service de rhumatologie Bordeaux France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04265144 on ClinicalTrials.gov ↗ ← All trials in France