NCT04917705Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Dec 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 22 Apr 2021
- Start date
- 25 Nov 2021
- Primary completion date
- Jun 2023
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04917705
What you commit to
- Study type: Interventional
- Planned participants: 55
- From 25 Nov 2021 to the primary completion date, Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking an immunosuppressant / immunomodulator treatment within 3 months before inclusion
- Immunosuppressive treatment (corticosteroids\> 15 mg, methotrexate, mycophenolate mofetil) introduced for more than 1 month
Other illness
- Diagnosed for another neuromuscular disease
Age
- Active or recent cancer \<3 years (apart from non-melanoma skin cancer).
- For all
- \- Pregnancy or breast feeding
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.