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

NCT ID: NCT04265144

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2034-06-30

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.

Detailed 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.

Conditions

Scleroderma; Systemic Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

subjects SSc diagnosed

Patient with systemic scleroderma according to the American College of Rheumatology (ACR) / EULAR 2013 criteria

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: BIOLOGICAL

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

Biopsy

Intervention Type: OTHER

Skin biopsies only for volunteers among patients

Bronchoalveolar samples

Intervention Type: OTHER

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

Biopsy

Intervention Type: OTHER

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

Interventions

Blood samples

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

Intervention Type: BIOLOGICAL

Biopsy

Skin biopsies only for volunteers among patients

Intervention Type: OTHER

Bronchoalveolar samples

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

Intervention Type: OTHER

Biopsy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Elise TRUCHETET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux - service de rhumatologie

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie-Elise TRUCHETET, MD, PhD

Role: CONTACT

marie-elise.truchetet@chu-bordeaux.fr

05.56.79.55.56 ext. +33

Thomas BARNETCHE, PhD

Role: CONTACT

thomas.barnetche@chu-bordeaux.fr

05.57.82.04.93 ext. +33

Facility Contacts

Marie-Elise TRUCHETET, MD, PhD

Role: primary

marie-elise.truchetet@chu-bordeaux.fr

05.56.79.55.56 ext. +33

Thomas BARNETCHE, PhD

Role: backup

thomas.barnetche@chu-bordeaux.fr

05.57.82.04.93 ext. +33

Other Identifiers

CHUBX 2019/42

Identifier Type: -

Identifier Source: org_study_id