Healthy Control Subjects, Raynaud Disease, Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease, Vascular Disease
Conditions
Brief summary
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
Interventions
PROCEDURE- Skin biopsy - Urine sample - Blood sample
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion. | 1 point at patient's inclusion visit | Metabolomic profiles will be classified in a database and compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc. | 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years | 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) |
Countries
France
Outcome results
None listed