NCT04917705 Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
| NCT ID | NCT04917705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-11-25 |
| Primary Completion | 2023-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 55 participants in total. It began in 2021-11-25 with a primary completion date of 2023-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04917705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04917705 currently recruiting?
Yes, NCT04917705 is actively recruiting participants. Contact the research team at alain.meyer1@chru-strasbourg.fr for enrollment information.
Where is the NCT04917705 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT04917705 clinical trial?
NCT04917705 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 55 participants.