Metabolomic Analysis of Systemic Sclerosis (SCLEROMICS)

University Hospital, Strasbourg, France

Status: Terminated

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

Treatments: Procedure: - Skin biopsy - Urine sample - Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02298777

5723

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

121 participants in 5 patient groups

Scleroderma (SSc) patients (beginners and established forms).

Description:

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)

Treatment:

Procedure: - Skin biopsy - Urine sample - Blood sample

Undifferentiated Connective Tissue Disease (UCDT) patients

Description:

Patients with criteria proposed by Mosca et al. (1998) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit

Treatment:

Procedure: - Skin biopsy - Urine sample - Blood sample

Raynaud disease patients

Description:

Patients with primary and isolated Raynaud disease Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit

Treatment:

Procedure: - Skin biopsy - Urine sample - Blood sample

Vascular disease patients

Description:

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

Treatment:

Procedure: - Skin biopsy - Urine sample - Blood sample

Healthy control subjects

Description:

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

Treatment:

Procedure: - Skin biopsy - Urine sample - Blood sample