Metabolomic Analysis of Systemic Sclerosis

  • STATUS
    Recruiting
  • End date
    Jul 11, 2024
  • participants needed
    140
  • sponsor
    University Hospital, Strasbourg, France
Updated on 11 September 2021
diabetes
early diagnosis
stroke
myocardial infarction
infarct
vascular disease
rheumatism
scleroderma
vascular disorder
systemic sclerosis
raynaud's phenomenon
raynaud's syndrome
raynaud phenomenon

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

Details
Condition Raynaud's Disease, Vascular Diseases, Scleroderma, Systemic sclerosis, Peripheral vascular disease, Circulation Disorders, Undifferentiated Connective Tissue Disease, Healthy Control Subjects, vascular disorder, raynaud, raynaud's syndrome, raynaud's phenomenon, raynaud phenomenon, vascular disease, vasculopathy, vasc, progressive systemic sclerosis
Treatment - Skin biopsy - Urine sample - Blood sample
Clinical Study IdentifierNCT02298777
SponsorUniversity Hospital, Strasbourg, France
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

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)
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