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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2030
  • participants needed
    500
  • sponsor
    University Hospital, Bordeaux
Updated on 16 May 2021
fibrosis
rheumatism
scleroderma
progressive systemic sclerosis
raynaud's phenomenon
raynaud's syndrome

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.

Description

Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. Its prevalence and incidence are difficult to assess, however, in France, a population survey conducted in Seine-St-Denis calculated a prevalence of 161 cases per million inhabitants.

The pathophysiology of SSc, the exact etiology of which remains unknown, involves an interaction between genetic and environmental factors. Its evolution can impact the aesthetic, functional and even vital prognosis of the affected patient.Within the analysis of SSc pathophysiology, a " very early systemic sclerosis " form of disease has been defined according to 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).

At present, no treatment to control this disease is available. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to research remains the development of well-documented patient cohorts with quality biological samples. The investigators had the opportunity to start a major work on this plan with the VISS study (Vasculopathy and Inflammation in Systemic Scleroderma study) in 2012 as part of a project promoted by the University Hospital of Bordeaux (NCT02562079). This project has paved the way for many local, national and international collaborations. It has made it possible to structure and federate various partners of the Bordeaux University Hospital around translational research on SSc.

The investigators wish to continue our research and collaborations by further strengthening our expertise in the collection of rare and valuable biological samples for this disease.

Details
Condition CONNECTIVE TISSUE DISEASE, Scleroderma, Systemic sclerosis, Dermatosis, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Skin Conditions, Connective Tissue Diseases, progressive systemic sclerosis
Treatment biopsy, blood samples, Bronchoalveolar samples
Clinical Study IdentifierNCT04265144
SponsorUniversity Hospital, Bordeaux
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

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
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