Identifying biomarkers in systemic sclerosis and inflammatory myopathies
Search for Diagnostic and Prognostic Biomarkers (Molecular Signatures) in Systemic Sclerosis and Inflammatory Myopathies by a Multi-OMIC Strategy Integrating a Single Cell Analysis Approach
NA · University Hospital, Strasbourg, France · NCT04917705
This study is trying to find specific markers in the blood and tissues of people with systemic sclerosis and inflammatory myopathies to better understand their diseases and how they progress over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Strasbourg, Bas-Rhin) |
| Trial ID | NCT04917705 on ClinicalTrials.gov |
What this trial studies
This study aims to identify diagnostic and prognostic biomarkers in patients with systemic sclerosis and inflammatory myopathies through a cohort approach. Participants will be classified into four populations based on their clinical and biological characteristics, and will undergo multiple sampling points over a five-year follow-up period. The study will utilize multi-omics analyses, including single-cell RNA sequencing, proteomics, and genomics, to characterize blood and tissue samples. The goal is to discover molecular signatures that correlate with disease characteristics and progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed inflammatory myopathy, early diffuse systemic cutaneous scleroderma, or those without these conditions but requiring diagnostic evaluation.
Not a fit: Patients with contraindications to muscle or skin biopsies, or those currently on immunosuppressive treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and personalized treatment strategies for patients with systemic sclerosis and inflammatory myopathies.
How similar studies have performed: While the approach of using multi-omics to identify biomarkers is gaining traction, this specific study's focus on systemic sclerosis and inflammatory myopathies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Control population without inflammatory myopathy (population 1), suspected myopathy for whom a blood test and muscle biopsy are required to confirm the diagnosis * Confirmed inflammatory myopathy (population 2) * Control population without systemic sclerosis (population 3), with primary Raynaud's phenomenon * Early diffuse systemic cutaneous scleroderma (population 4) * Male or female (age ≥ 18, no upper age limit) Exclusion Criteria: Populations 1 \& 2 * Contraindication to muscle biopsy * Diagnosed for another neuromuscular disease * Taking an immunosuppressant / immunomodulator treatment within 3 months before inclusion * Unbalanced cardiovascular pathology Population 3 \& 4 * Contraindication to skin biopsy * Capillaroscopic and / or immunological anomaly suggesting scleroderma * Suspicion of scleroderma but diagnosed for another connectivitis * Immunosuppressive treatment (corticosteroids\> 15 mg, methotrexate, mycophenolate mofetil) introduced for more than 1 month * Active or recent cancer \<3 years (apart from non-melanoma skin cancer). For all \- Pregnancy or breast feeding
Where this trial is running
Strasbourg, Bas-Rhin
- University Hospital of Hautepierre — Strasbourg, Bas-Rhin, France (RECRUITING)
Study contacts
- Study coordinator: Alain MEYER, MD
- Email: alain.meyer1@chru-strasbourg.fr
- Phone: + 33 3 88 12 79 55
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.
Conditions: Systemic Sclerosis, Inflammatory Myopathies, Scleroderma, Myopathy, Multi-OMICS, Biomarkers, Single-cell