Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04265144

Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases

Led by University Hospital, Bordeaux · Updated on 2025-09-04

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying systemic sclerosis (SSc), a rare connective tissue disease marked by blood vessel problems and severe fibrosis. This disease's cause is not fully understood, and there are no current treatments. The study aims to observe the natural progression of SSc over five years by following a group of patients carefully documented with biological samples to support research. Participants with systemic sclerosis or very early signs of the disease will be part of the cohort. Researchers will collect blood samples from all patients and may collect skin biopsies, bronchoalveolar samples if lung flare-ups occur, and digestive biopsies if needed during standard care. These biological samples help understand the disease better and develop collaborations for future research. During the study, patients will be evaluated at the start and after 60 months to track changes in their clinical condition, including lung and kidney health, and disease activity scores. The study will monitor the development of lung hypertension, interstitial lung disease, and kidney crises, as well as treatment strategies. Participation involves providing samples and attending assessments over five years to help researchers learn about SSc progression and its effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old
  • Diagnosis of systemic scleroderma according to ACR/EULAR 2013 criteria or very early systemic sclerosis defined by Raynaud's phenomenon and positive auto-antibodies
  • Affiliated with or benefiting from a social security scheme
  • Signed free, informed, and written consent before any research procedures
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients under guardianship, curatorship, or any other legal protection regime

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 60 months

Participants diagnosed with systemic sclerosis are observed and biological samples such as blood and biopsies may be collected depending on medical needs and volunteer agreement.

Assessments at baseline and at 60 months

Trial Site Locations

Total: 1 location

1

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Actively Recruiting

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Research Team

M

Marie-Elise TRUCHETET, MD, PhD

T

Thomas BARNETCHE, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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