Metabolomic Analysis of Systemic Sclerosis
This trial is active, not recruiting.
|Conditions||scleroderma (limited and diffuse), undifferentiated connective tissue disease, raynaud disease, vascular disease, healthy control subjects|
|Treatment||- skin biopsy - urine sample - blood sample|
|Sponsor||University Hospital, Strasbourg, France|
|Start date||October 2014|
|End date||October 2019|
|Trial size||140 participants|
|Trial identifier||NCT02298777, 5723|
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).
- 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
|Observational model||case control|
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
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
Male or female participants at least 18 years old.
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)
|Official title||Metabolomic Analysis of Systemic Sclerosis|
|Principal investigator||Chatelus Emmanuel, MD|
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