Actively Recruiting
Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Led by University Hospital, Strasbourg, France · Updated on 2021-12-15
55
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Systemic sclerosis and inflammatory myopathies, which sometimes combine (scleromyositis), have shared pathophysiological elements. In both diseases, many cell subtypes are involved in damage to organs such as T lymphocytes, B lymphocytes, and unconventional (non-B, non-T) lymphocytes called innate lymphoid cell (ILC). The increasing complexity of our understanding of the immune system (multiplication of recognized cell subtypes) also makes the strategies for analyzing pathophysiological mechanisms more complex. Currently, no biomarker perfectly predicts the phenotype and evolution of patients. Multi-OMIC analyzes will be performed (identification of cell populations as well as genomic, transcriptomic and proteomic characterization) in blood and tissue samples (skin and muscle biopsy) in patients with systemic sclerosis and inflammatory myopathies, with the objective of identifying discriminating molecular signatures (biomarkers) according to the characteristics of the disease and its evolution.
CONDITIONS
Official Title
Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Control population without inflammatory myopathy, suspected myopathy needing blood test and muscle biopsy for diagnosis
- Confirmed inflammatory myopathy
- Control population without systemic sclerosis, with primary Raynaud's phenomenon
- Early diffuse systemic cutaneous scleroderma
- Male or female aged 18 years or older, no upper age limit
You will not qualify if you...
- Contraindication to muscle biopsy (populations 1 and 2)
- Diagnosed with another neuromuscular disease (populations 1 and 2)
- Taking immunosuppressant or immunomodulator treatment within 3 months before inclusion (populations 1 and 2)
- Unbalanced cardiovascular disease (populations 1 and 2)
- Contraindication to skin biopsy (populations 3 and 4)
- Capillaroscopic or immunological anomaly suggesting scleroderma (populations 3 and 4)
- Suspicion of scleroderma but diagnosed with another connective tissue disease (populations 3 and 4)
- Immunosuppressive treatment including corticosteroids over 15 mg, methotrexate, or mycophenolate mofetil started for more than 1 month (populations 3 and 4)
- Active or recent cancer within past 3 years except non-melanoma skin cancer (populations 3 and 4)
- Pregnancy or breastfeeding (all populations)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital of Hautepierre
Strasbourg, Bas-Rhin, France, 67000
Actively Recruiting
Research Team
A
Alain MEYER, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
0
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