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Recruiting NCT05532865

Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking

— Observational Systemic Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples, Stool samples, Skin swab samples, Questionnaires on quality of life, pain and disability.
Who it may be relevant to
Registry conditions: Systemic Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank

Overview

This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis. It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.

Interventions

  • Other Blood samples
    80 ml of blood samples collected at inclusion and at 18 months
  • Other Stool samples
    A stool sample for collection of digestive microbiota at inclusion
  • Other Skin swab samples
    A skin swab sample for collection of skin microbiota at inclusion and at 18 months
  • Other Questionnaires on quality of life, pain and disability
    At inclusion and each year for 5 years
  • Other Skin biopsies
    At inclusion and 18 months

Primary outcome measures

  • Age [Time frame: 5 years]
  • Sex [Time frame: 5 years]
  • Weight [Time frame: 5 years]
  • Medical history [Time frame: 5 years]
  • Family history [Time frame: 5 years]
  • Rodnan score [Time frame: 5 years]
  • active digital ulcers [Time frame: 5 years]
  • dyspnea [Time frame: 5 years]
  • Free Carbon Monoxide Diffusion (DLCO) [Time frame: 5 years]
  • 6-minute walk test [Time frame: 5 years]
Secondary outcome measures (3)
  • SF-36 (Short-Form 36) [Time frame: 5 years]
  • BPI : Pain scale [Time frame: 5 years]
  • HAQ- Health Assessment Questionnaire - Disability Index [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
  • Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
  • Patient affiliated to the social security system
  • Patient having signed a written informed consent.

Exclusion criteria

  • Minor
  • Patient under legal protection (guardianship, curatorship)
  • Refusal to participate
  • Patient unable to consent
  • Pregnant or breastfeeding woman
  • Hemoglobin (Hb) level < 7g/dl

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHRU de Brest — Brest

Identifiers

NCT: NCT05532865 · 29BRC21.0258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗