Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Recruiting now · Not applicable
Conditions studied: Systemic Sclerosis, Inflammatory Myopathies
In brief
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.
Key facts
- Study ID
- NCT04917705
- Run by
- University Hospital, Strasbourg, France
- People needed
- 55
- Starts
- 2021-11-25
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2021-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 it is running
- University Hospital of Hautepierre — Strasbourg, Bas-Rhin, France (enrolling)
Full record on ClinicalTrials.gov
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