Metabolomic Analysis of Systemic Sclerosis

Vascular Disease Clinical Trial

— SCLEROMICS  

Official title:

Metabolomic Analysis of Systemic Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02298777
• Other study ID #: 5723
• Status: Recruiting
• Start date: December 2014
• Est. completion date: February 2026

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Chatelus Emmanuel, MD
• Phone: 03 88 12 81 15
• Email: emmanuel.chatelus[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Healthy Control Subjects
• Raynaud Disease
• Scleroderma (Limited and Diffuse)
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Undifferentiated Connective Tissue Disease
• Undifferentiated Connective Tissue Diseases
• Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHU	Dijon
France	Hôpitaux privés de Metz	Metz
France	CHU	Nancy
France	CHU	Reims
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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