RecruitingNCT05532865

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

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


Sponsor

University Hospital, Brest

Enrollment

100 participants

Start Date

Oct 13, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

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

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Interventions

OTHERBlood samples

80 ml of blood samples collected at inclusion and at 18 months

OTHERStool samples

A stool sample for collection of digestive microbiota at inclusion

OTHERSkin swab samples

A skin swab sample for collection of skin microbiota at inclusion and at 18 months

OTHERQuestionnaires on quality of life, pain and disability

At inclusion and each year for 5 years

OTHERSkin biopsies

At inclusion and 18 months


Locations(1)

CHRU de Brest

Brest, France

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NCT05532865


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