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

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: Blood samples
* Other: Stool samples
* Other: Skin swab samples
* Other: Questionnaires on quality of life, pain and disability


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with systemic sclerosis<br>It is a descriptive cohort of systemic sclerosis patients | Other: Blood samples<br>* 80 ml of blood samples collected at inclusion and at 18 months<br>Other: Stool samples<br>* A stool sample for collection of digestive microbiota at inclusion<br>Other: Skin swab samples<br>* A skin swab sample for collection of skin microbiota at inclusion and at 18 months<br>Other: Questionnaires on quality of life, pain and disability<br>* At inclusion and each year for 5 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | To assess whether age correlates with disease profile and progression | 5 years | 
| Sex | To assess whether sex correlates with disease profile and progression | 5 years | 
| Weight | To assess whether weight correlates with disease profile and progression | 5 years | 
| Medical history | To assess whether medical history predicts the pattern and course of the disease | 5 years | 
| Family history | To assess whether family history predicts the pattern and course of the disease | 5 years | 
| Rodnan score | This score evaluates the thickness of the skin from 0 to 51. 0 meaning the absence of scleroderma (the healthiest score) and 51 completely sclerotic skin (the worst possible score) | 5 years | 
| active digital ulcers | 4 characteristics must be taken into account: the type of ulcer: mechanical/on calcinosis/ischemic the recent/semi-recent/chronic character, the painful character or not, the total number of fingers affected on the 10 fingers. | 5 years | 
| dyspnea | stage I: absence of dyspnea for usual efforts: no discomfort is felt in everyday life, stage II: dyspnoea for usual heavy exertion, such as brisk or hill walking or climbing stairs (≥ 2 floors), stage III: dyspnea for low intensity efforts of everyday life, such as walking on flat ground or climbing stairs (< 2 floors), stage IV: permanent dyspnea at rest or for minimal effort (putting on a garment, for example) | 5 years | 
| Free Carbon Monoxide Diffusion (DLCO) | Free Carbon Monoxide Diffusion (DLCO) in percentage. | 5 years | 
| 6-minute walk test | Distance (in meters) covered in the 6-minute walk test. | 5 years | 
| systemic pulmonary arterial pressures | Measured on cardiac ultrasound. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 years | 
| 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 | 5 years | 
| 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Sclerosis, Patient library