Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Jun 1, 2021
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking for specific markers in the blood and tissue of patients with systemic sclerosis and inflammatory myopathies, including a related condition known as scleromyositis. These markers, or biomarkers, can help doctors understand how these diseases affect the body and how they change over time. By studying different types of immune cells and their characteristics in blood and tissue samples, researchers hope to find unique signs that can help predict the disease's course and tailor treatment better for each patient.
To participate in this trial, individuals must be at least 18 years old and meet certain criteria, such as having confirmed inflammatory myopathy or early systemic scleroderma. Participants will undergo blood tests and biopsies (small tissue samples) to gather important information. It's important to know that some people may not be eligible, especially if they have other serious health conditions or are taking certain medications. Overall, this trial aims to improve understanding and treatment of these complex diseases, which could ultimately benefit many patients.
Gender
ALL
Eligibility criteria
- 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
About University Hospital, Strasbourg, France
The University Hospital of Strasbourg, France, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the institution collaborates with a diverse range of healthcare professionals and research teams to explore cutting-edge therapies and treatment modalities. With state-of-the-art facilities and a multidisciplinary approach, the University Hospital of Strasbourg plays a pivotal role in translating scientific discoveries into effective clinical applications, contributing significantly to the advancement of medical knowledge and improved patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Strasbourg, Bas Rhin, France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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