Metabolomic Analysis of Systemic Sclerosis

Recruiting

• Conditions: Undifferentiated Connective Tissue Disease; Scleroderma (Limited and Diffuse); Healthy Control Subjects; Raynaud Disease; Vascular Disease
• Interventions: Procedure: - Skin biopsy - Urine sample - Blood sample

• Registration Number: NCT02298777
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-24
• Study Start: 2014-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Undifferentiated Connective Tissue Disease (UCDT) patients	- Skin biopsy - Urine sample - Blood sample	Patients with criteria proposed by Mosca et al. (1998) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit
Raynaud disease patients	- Skin biopsy - Urine sample - Blood sample	Patients with primary and isolated Raynaud disease Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit
Vascular disease patients	- Skin biopsy - Urine sample - Blood sample	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
Healthy control subjects	- Skin biopsy - Urine sample - Blood sample	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
Scleroderma (SSc) patients (beginners and established forms).	- Skin biopsy - Urine sample - Blood sample	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU; 🇫🇷 Reims, France

Hôpitaux privés de Metz; 🇫🇷 Metz, France