RecruitingNot ApplicableNCT04917705

Search for Diagnostic and Prognostic 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

Sponsor

University Hospital, Strasbourg, France

Enrollment

55 participants

Start Date

Nov 25, 2021

Study Type

INTERVENTIONAL

Conditions

Systemic Sclerosis Inflammatory Myopathies

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is searching for new blood and tissue markers that could help diagnose and predict the course of two autoimmune conditions: inflammatory muscle diseases (myopathies) and systemic sclerosis (scleroderma, a disease where the immune system attacks connective tissue). **You may be eligible if:** - You are 18 or older - You have suspected or confirmed inflammatory muscle disease (myopathy), OR - You have primary Raynaud's phenomenon (fingers turning white or blue in the cold), OR - You have early widespread scleroderma (systemic sclerosis) **You may NOT be eligible if:** - You have a contraindication to a muscle or skin biopsy - You have been taking immunosuppressant medications recently - You have another diagnosed neuromuscular or connective tissue disease - You have an active or recent cancer (within 3 years) - You have an uncontrolled cardiovascular condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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