Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

Study Overview
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Brief Summary
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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,

Official Title
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Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Trap Myelin Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: These criteria depend on the subgroup belongs to the patient. Signed consent Membership of a social security system Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Relapsing Multiple Sclerosis- group 1<br>Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months. | Device: Trap Myelin Test<br> <br> |
| Other: Relapsing Multiple Sclerosis- group 2<br>Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months. | Device: Trap Myelin Test<br> <br> |
| Other: secondary progressive multiple sclerosis- Group 3<br>Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis | Device: Trap Myelin Test<br> <br> |
| Other: primary progressive multiple sclerosis- group 4<br>Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis | Device: Trap Myelin Test<br> <br> |
| Other: control 1<br>healthy volunteers | Device: Trap Myelin Test<br> <br> |
| Other: Control 2<br>Patients with central or peripheral neurological non-inflammatory, non-autoimmune. | Device: Trap Myelin Test<br> <br> |
| Other: Control 3<br>Patients having an autoimmune pathology | Device: Trap Myelin Test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis | 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-myéline will thus be estimated by means of the area calculated under this curve | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, TRAP, TRAP-Myéline