Metabolomic Analysis of Systemic Sclerosis

Study Overview
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Brief Summary
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Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years. The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years). Secondary purposes: Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients

Official Title
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Metabolomic Analysis of Systemic Sclerosis

Conditions
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Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease, Raynaud Disease, Vascular Disease, Healthy Control Subjects

Intervention / Treatment
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* Procedure: - Skin biopsy - Urine sample - Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Group 1 (scleroderma) : Patients with ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001) Group 2 (UCDT) : Patients with criteria proposed by Mosca et al. (1998) Group 3 (Raynaud) : Patients with primary and isolated Raynaud disease Group 4 (vascular disease) : Patients with type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke Group 5 (healthy control) : healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease) Exclusion criteria: Group 1 (scleroderma) : Patients not fulfilling ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001), or with another auto-immune disease Group 2 (UCDT) : Patients not fulfilling criteria proposed by Mosca et al. (1998) Group 3 (Raynaud) : Patients with no Raynaud disease Group 4 (vascular disease) : Patients with no vascular disease Group 5 (healthy control) : Patients with sign of connective tissue disease, Raynaud, or vascular disease)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scleroderma (SSc) patients (beginners and established forms).<br>Patients with the ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001) Biological samples (skin, urine and blood): 1st point at patient's inclusion visit 2nd point (optional) at SSc patient's visceral complication (assessed during 3 years) | Procedure: - Skin biopsy - Urine sample - Blood sample<br> <br> |
| Undifferentiated Connective Tissue Disease (UCDT) patients<br>Patients with criteria proposed by Mosca et al. (1998) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit | Procedure: - Skin biopsy - Urine sample - Blood sample<br> <br> |
| Raynaud disease patients<br>Patients with primary and isolated Raynaud disease Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit | Procedure: - Skin biopsy - Urine sample - Blood sample<br> <br> |
| Vascular disease patients<br>Patients with vascular disease (type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit | Procedure: - Skin biopsy - Urine sample - Blood sample<br> <br> |
| Healthy control subjects<br>Healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit | Procedure: - Skin biopsy - Urine sample - Blood sample<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion. | Metabolomic profiles will be classified in a database and compared. | 1 point at patient's inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc. | Metabolomic profiles will be classified in a database and compared between each other's (SSc, UCDT, RD, VD and healthy control arms) We will look for a correlation between these profiles and the evolution of clinical and biological characteristics of SSc (SSc arm) | 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years |