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Metabolomic Analysis of Systemic Sclerosis

Key facts

Where
Dijon, Metz, Reims és Strasbourg, FranciaországSee the 4 sites

Where in Franciaország

  • CHUDijon, FranciaországNo longer taking part
  • Hopitaux Prives De MetzMetz, FranciaországNo longer taking part
  • CHUReims, FranciaországNo longer taking part
  • Hopitaux Universitaires de StrasbourgStrasbourg, FranciaországNo longer taking part

Trial details

Who runs it
University Hospital, Strasbourg, France
Trial code
NCT02298777
Record updated
2025. augusztus 8.
Original description
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.Read full original descriptionShow less

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

Inclusion: 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: Group 1 (scleroderma) : Patients not fulfilling ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001), or with another auto-immune disease; 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); Group 2 (UCDT) : Patients not fulfilling criteria proposed by Mosca et al. (1998).

ClinicalTrials.gov NCT02298777