Metabolomic Analysis of Systemic Sclerosis (SCLEROMICS)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21079
- CHU
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Metz, France, 57045
- Hopitaux Prives De Metz
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Reims, France, 51092
- CHU
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Strasbourg, France, 67000
- Hopitaux Universitaires de Strasbourg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Scleroderma (SSc) patients (beginners and established forms).
Patients with the ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001) Biological samples (skin, urine and blood):
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Undifferentiated Connective Tissue Disease (UCDT) patients
Patients with criteria proposed by Mosca et al. (1998) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit |
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Raynaud disease patients
Patients with primary and isolated Raynaud disease Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit |
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Vascular disease patients
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 |
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Healthy control subjects
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
Time Frame: 1 point at patient's inclusion visit
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Metabolomic profiles will be classified in a database and compared.
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1 point at patient's inclusion visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc.
Time Frame: 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years
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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)
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1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Chatelus Emmanuel, MD, Hopitaux Universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Livedoid Vasculopathy
- Cardiovascular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Embolism and Thrombosis
- Skin Diseases
- Skin Diseases, Vascular
- Peripheral Vascular Diseases
- Thrombosis
- Undifferentiated Connective Tissue Diseases
- Vascular Diseases
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Connective Tissue Diseases
- Raynaud Disease
Other Study ID Numbers
- 5723
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