Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis (TRAP-Myéline)

May 15, 2017 updated by: Nantes University Hospital

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • University Hospital of Bordeaux
      • Bron, France
        • Hopital neurologigue Pierre Wertheimer
      • Clermont Ferrand, France
        • University Hospital of Clermont Ferrand
      • Lille, France
        • University Hospital of Lille
      • Marseille, France
        • University Hospital of Marseille
      • Montpellier, France
        • University Hospital of Montpellier
      • Nantes, France
        • University Hospital of Nantes
      • Nice, France
        • University Hospital of Nice
      • Rennes, France
        • University Hospital of Rennes
      • Strasbourg, France
        • University Hospital of Strasbourg
      • Toulouse, France
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/06-S
  • 2010-A00892-37 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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