Metabolomic Analysis of Systemic Sclerosis (SCLEROMICS)

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

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Chatelus Emmanuel, MD; Phone Number: 0033 03 88 12 81 15; Email: emmanuel.chatelus@chru-strasbourg.fr
• Study Contact Backup: Name: Kleinmann Jean-François; Phone Number: 03 88 12 79 62; Email: jean-francois.kleinmann@chru-strasbourg.fr

Study Locations

• France
  • Dijon, France, 21079
    • Completed
    • CHU
  • Metz, France, 57045
    • Completed
    • Hopitaux Prives de Metz
  • Nancy, France, 54511
    • Withdrawn
    • CHU
  • Reims, France, 51092
    • Active, not recruiting
    • CHU
  • Strasbourg, France, 67000
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
    • Contact: Emmanuel CHATELUS, MD; Phone Number: 0033 03 88 12 81 15; Email: emmanuel.chatelus@chru-strasbourg.fr
    • Principal Investigator: Emmanuel CHATELUS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with systemic sclerosis (SSc),

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc.	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)	1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Chatelus Emmanuel, MD, Hopitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimated): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases; Embolism and Thrombosis; Skin Diseases, Vascular; Thrombosis; Peripheral Vascular Diseases; Livedoid Vasculopathy; Vascular Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Connective Tissue Diseases; Raynaud Disease; Undifferentiated Connective Tissue Diseases
• Other Study ID Numbers: 5723