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Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Strasbourg, France
NCT04917705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 discri

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📋 Eligibility rules (as published)
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
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What it tests

  • Collection of biological samples
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Where

1 site
University Hospital of Hautepierre
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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