Searching for Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Studies blood and skin or muscle samples from adults with systemic sclerosis or inflammatory myopathies.
Plain-language title generated from the registry record
Registry title: Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Key facts
- Where
- Strasbourg, FranceSee the site
Where in France
- University Hospital of HautepierreStrasbourg, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Strasbourg, France
- Trial code
- NCT04917705
- Record updated
- 15 December 2021
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Taking an immunosuppressant / immunomodulator treatment within 3 months before inclusion; Immunosuppressive treatment (corticosteroids> 15 mg, methotrexate, mycophenolate mofetil) introduced for more than 1 month; Diagnosed for another neuromuscular disease; Active or recent cancer <3 years (apart from non-melanoma skin cancer); For all; Populations 1 \& 2; Contraindication to muscle biopsy; 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; Pregnancy or breast feeding.