Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

NCT ID: NCT01723631

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-10-31

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,

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Relapsing Multiple Sclerosis- group 1

Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

Relapsing Multiple Sclerosis- group 2

Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

secondary progressive multiple sclerosis- Group 3

Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

primary progressive multiple sclerosis- group 4

Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

control 1

healthy volunteers

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

Control 2

Patients with central or peripheral neurological non-inflammatory, non-autoimmune.

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

Control 3

Patients having an autoimmune pathology

Group Type OTHER

Trap Myelin Test

Intervention Type DEVICE

Interventions

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Trap Myelin Test

Intervention Type DEVICE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Bordeaux

Bordeaux, , France

Site Status

Hopital neurologigue Pierre Wertheimer

Bron, , France

Site Status

University Hospital of clermont Ferrand

Clermont-Ferrand, , France

Site Status

University Hospital of Lille

Lille, , France

Site Status

University Hospital of Marseille

Marseille, , France

Site Status

University Hospital of Montpellier

Montpellier, , France

Site Status

University Hospital of Nantes

Nantes, , France

Site Status

University Hospital of Nice

Nice, , France

Site Status

University Hospital of Rennes

Rennes, , France

Site Status

University Hospital of Strasbourg

Strasbourg, , France

Site Status

University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2010-A00892-37

Identifier Type: OTHER

Identifier Source: secondary_id

BRD/10/06-S

Identifier Type: -

Identifier Source: org_study_id

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