Status:
RECRUITING
Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Systemic Sclerosis
Inflammatory Myopathies
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Cohort study, monocentric, comparative, non-randomized, open-label, prospective and longitudinal, quasi-experimental. Participating subjects will be classified according to their clinical, biological...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04917705
Start Date
November 25 2021
End Date
June 1 2028
Last Update
December 15 2021
Active Locations (1)
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1
University Hospital of Hautepierre
Strasbourg, Bas-Rhin, France, 67000