Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Device: Trap Myelin Test
- Registration Number
- NCT01723631
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 189
- These criteria depend on the subgroup belongs to the patient.
- Signed consent
- Membership of a social security system
- Whatever the patient group or control:
- Processing immunosuppressive.
- Processing by a monoclonal antibody.
- Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
- Carcinomatous pathology known evolving.
- People under guardianship.
- Pregnant women.
- Patients not motivated to study. Known patients with anemia (hemoglobin <10g/100ml)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Relapsing Multiple Sclerosis- group 1 Trap Myelin Test Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months. primary progressive multiple sclerosis- group 4 Trap Myelin Test Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis Control 3 Trap Myelin Test Patients having an autoimmune pathology secondary progressive multiple sclerosis- Group 3 Trap Myelin Test Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis Control 2 Trap Myelin Test Patients with central or peripheral neurological non-inflammatory, non-autoimmune. Relapsing Multiple Sclerosis- group 2 Trap Myelin Test Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months. control 1 Trap Myelin Test healthy volunteers
- Primary Outcome Measures
Name Time Method Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis 2 years The main criterion corresponds to the area under the curve ROC (Receiver operating characteristic). The curve ROC is a graphic representation of the existing relation between the sensibility and the specificity of a test, calculated for all the values possible thresholds. The performance of the test TRAP-myΓ©line will thus be estimated by means of the area calculated under this curve
- Secondary Outcome Measures
Name Time Method Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated 2 years
Trial Locations
- Locations (11)
University Hospital of Strasbourg
π«π·Strasbourg, France
University Hospital of Bordeaux
π«π·Bordeaux, France
Hopital neurologigue Pierre Wertheimer
π«π·Bron, France
University Hospital of clermont Ferrand
π«π·Clermont Ferrand, France
University Hospital of Lille
π«π·Lille, France
University Hospital of Marseille
π«π·Marseille, France
University Hospital of Nantes
π«π·Nantes, France
University Hospital of Nice
π«π·Nice, France
University Hospital of Montpellier
π«π·Montpellier, France
University Hospital of Rennes
π«π·Rennes, France
University Hospital of Toulouse
π«π·Toulouse, France