Analyzing Metabolites in Scleroderma and Related Conditions
Metabolomic Analysis of Systemic Sclerosis
This study is trying to find unique metabolic patterns in people with scleroderma and related conditions to help with early diagnosis and understanding the disease better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 5 sites (Dijon and 4 other locations) |
| Trial ID | NCT02298777 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify distinct metabolic profiles associated with systemic sclerosis (SSc) and related conditions, focusing on early diagnosis and prognosis. By comparing metabolomic data from patients with early-stage SSc to those with established disease, as well as to individuals with undifferentiated connective tissue disease, Raynaud's disease, vascular disease, and healthy controls, the study seeks to uncover potential biomarkers. Participants will provide blood, urine, and skin samples for comprehensive analysis of their metabolomic profiles.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with systemic sclerosis, undifferentiated connective tissue disease, primary Raynaud's disease, vascular disease, or healthy controls without any connective tissue disease.
Not a fit: Patients with other autoimmune diseases or those not meeting the specific diagnostic criteria for the included conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of systemic sclerosis and related conditions.
How similar studies have performed: While the approach of using metabolomic analysis is gaining traction, this specific study's focus on early-stage systemic sclerosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Dijon and 4 other locations
- Chu — Dijon, France (Completed)
- Hôpitaux privés de Metz — Metz, France (Completed)
- Chu — Nancy, France (Withdrawn)
- Chu — Reims, France (Active_not_recruiting)
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Chatelus Emmanuel, MD — Hôpitaux Universitaires de Strasbourg
- Study coordinator: Chatelus Emmanuel, MD
- Email: emmanuel.chatelus@chru-strasbourg.fr
- Phone: 03 88 12 81 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.