Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking
NCT ID: NCT05532865
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-10-13
2032-10-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Adults with systemic sclerosis
It is a descriptive cohort of systemic sclerosis patients
Blood samples
80 ml of blood samples collected at inclusion and at 18 months
Stool samples
A stool sample for collection of digestive microbiota at inclusion
Skin swab samples
A skin swab sample for collection of skin microbiota at inclusion and at 18 months
Questionnaires on quality of life, pain and disability
At inclusion and each year for 5 years
Skin biopsies
At inclusion and 18 months
Interventions
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Blood samples
80 ml of blood samples collected at inclusion and at 18 months
Stool samples
A stool sample for collection of digestive microbiota at inclusion
Skin swab samples
A skin swab sample for collection of skin microbiota at inclusion and at 18 months
Questionnaires on quality of life, pain and disability
At inclusion and each year for 5 years
Skin biopsies
At inclusion and 18 months
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient under legal protection (guardianship, curatorship)
* Refusal to participate
* Patient unable to consent
* Pregnant or breastfeeding woman
* Hemoglobin (Hb) level \< 7g/dl
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU de Brest
Brest, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC21.0258
Identifier Type: -
Identifier Source: org_study_id
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