Overview

This trial is active, not recruiting.

Conditions scleroderma (limited and diffuse), undifferentiated connective tissue disease, raynaud disease, vascular disease, healthy control subjects
Treatment - skin biopsy - urine sample - blood sample
Sponsor University Hospital, Strasbourg, France
Start date October 2014
End date October 2019
Trial size 140 participants
Trial identifier NCT02298777, 5723

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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)
- 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
- 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
- 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
- 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
- skin biopsy - urine sample - blood sample

Primary Outcomes

Measure
change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
time frame: 1 point at patient's inclusion visit

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Metabolomic Analysis of Systemic Sclerosis
Principal investigator Chatelus Emmanuel, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.