About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Minor
Patient under legal protection (guardianship, curatorship)
Refusal to participate
Patient unable to consent
Trial population
Major patient with systemic sclerosis defined according to the EULAR 2013 criteria
Trial design
Case-only
Prospective
Treatments tested in this trial
Blood samples
Other intervention80 ml of blood samples collected at inclusion and at 18 months
Stool samples
Other interventionA stool sample for collection of digestive microbiota at inclusion
Skin swab samples
Other interventionA skin swab sample for collection of skin microbiota at inclusion and at 18 months
Questionnaires on quality of life, pain and disability
Other interventionAt inclusion and each year for 5 years
Skin biopsies
Other interventionAt inclusion and 18 months
Treatment groups
Trial outcomes
Primary outcomes
Age
To assess whether age correlates with disease profile and progression
Sex
To assess whether sex correlates with disease profile and progression
Weight
To assess whether weight correlates with disease profile and progression
Medical history
To assess whether medical history predicts the pattern and course of the disease
Secondary outcomes
SF-36 (Short-Form 36)
The SF-36 is an indicator of health status and quality of life. The SF-36 has eight dimensions; the scores are weighted sums of the questions in each section. This scores range from 0 - 100. Lower scores indicate more disability and higher scores less disability. The eight dimensions of this score are: * Vitality * Physical functioning * Bodily pain * General health perceptions * Physical role functioning * Emotional role functioning * Social role functioning * Mental health
BPI : Pain scale
A quick and easy way to measure the intensity of pain and its impact on daily activities. Patients rate the maximum, minimum, average and current intensity of their pain and the influence of pain on seven aspects of functional ability. 3 scores are obtained between 0 and 10, with 10 corresponding to : * the worst pain experienced in the last 24 hours * the highest pain intensity combining the most intense, the least intense, the average pain and the pain experienced at the time of the questionnaire * the highest interference of the pain on daily activities
HAQ- Health Assessment Questionnaire - Disability Index
Evolution of HAQ-DI (Health Assessment Questionnaire - Disability Index) during follow-up 8 fields questionnaire (DRESSING \& GROOMING, ARISING, EATING, WALKING, HYGIENE, REACH, GRIP, Other activities), scaled from 0 to 3, 3 meaning a worse outcome
Sponsors and contacts
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