Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

Nantes University Hospital189 enrolled

Overview

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,

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

189

Conditions

Multiple Sclerosis

Interventions

Trap Myelin TestDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (11)

University Hospital of Bordeaux

Bordeaux, France

Hopital neurologigue Pierre Wertheimer

Bron, France

University Hospital of clermont Ferrand

Clermont-Ferrand, France

University Hospital of Lille

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated

Time frame: 2 years

Data from ClinicalTrials.gov

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