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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02298777
Other study ID # 5723
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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