Metabolomic Analysis of Systemic Sclerosis

NCT02298777 | Terminated

• 1 other identifier: 5723
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 4

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.

  Metabolomic profiles will be classified in a database and compared.

  1 point at patient's inclusion visit

Secondary Outcomes (1)

• 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

Study Arms (5)

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)

Procedure: - 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

Procedure: - 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

Procedure: - 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

Procedure: - 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

Procedure: - Skin biopsy - Urine sample - Blood sample

Interventions

- Skin biopsy - Urine sample - Blood sample PROCEDURE

Healthy control subjects; Raynaud disease patients; Scleroderma (SSc) patients (beginners and established forms).; Undifferentiated Connective Tissue Disease (UCDT) patients; Vascular disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with systemic sclerosis (SSc),

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (4)

CHU

Dijon, 21079, France

Location

Hôpitaux privés de Metz

Metz, 57045, France

Location

CHU

Reims, 51092, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Undifferentiated Connective Tissue Diseases; Raynaud Disease; Vascular Diseases

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Study Officials

• Chatelus Emmanuel, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2014
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (4)