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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TERMINATED
121 participants
OBSERVATIONAL
2014-12-31
2025-04-24
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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):
* 1st point at patient's inclusion visit
* 2nd point (optional) at SSc patient's visceral complication (assessed during 3 years)
- Skin biopsy - Urine sample - Blood sample
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
- Skin biopsy - Urine sample - Blood sample
Raynaud disease patients
Patients with primary and isolated Raynaud disease
Biological samples (skin, urine and blood):
\- 1single point at patient's inclusion visit
- Skin biopsy - Urine sample - Blood sample
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
- Skin biopsy - Urine sample - Blood sample
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
- Skin biopsy - Urine sample - Blood sample
Interventions
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- Skin biopsy - Urine sample - Blood sample
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
Yes
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Chatelus Emmanuel, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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CHU
Dijon, , France
Hôpitaux privés de Metz
Metz, , France
CHU
Reims, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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Other Identifiers
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5723
Identifier Type: -
Identifier Source: org_study_id
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