Clinical trial NCT02298777: Metabolomic Analysis of Systemic Sclerosis
Official title: Metabolomic Analysis of Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scleroderma (Limited and Diffuse)
Undifferentiated Connective Tissue Disease
Raynaud Disease
Vascular Disease
Healthy Control Subjects
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic sclerosis (SSc),

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


Eligibility criteria: 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)

Primary outcomes:
measure: change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
timeFrame: 1 point at patient's inclusion visit
Secondary outcomes:
measure: Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc.
timeFrame: 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU
city: Metz
country: France
facility: Hôpitaux privés de Metz
city: Nancy
country: France
facility: CHU
city: Reims
country: France
facility: CHU
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Chatelus Emmanuel, MD
role: PRINCIPAL_INVESTIGATOR
References: