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

This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01723631
First received: November 6, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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,


Condition Intervention
Multiple Sclerosis
Device: Trap Myelin Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
secondary progressive multiple sclerosis- Group 3
Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis
Device: Trap Myelin Test
primary progressive multiple sclerosis- group 4
Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis
Device: Trap Myelin Test
control 1
healthy volunteers
Device: Trap Myelin Test
Control 2
Patients with central or peripheral neurological non-inflammatory, non-autoimmune.
Device: Trap Myelin Test
Control 3
Patients having an autoimmune pathology
Device: Trap Myelin Test

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723631

Contacts
Contact: David Laplaud, PH david.laplaud@chu-nantes.fr

Locations
France
University Hospital of Bordeaux Recruiting
Bordeaux, France
Principal Investigator: Bruno Brochet, PU-PH         
Hopital neurologigue Pierre Wertheimer Recruiting
Bron, France
Principal Investigator: Christian Confavreux, Pu-PH         
University Hospital of clermont Ferrand Not yet recruiting
Clermont Ferrand, France
Principal Investigator: Pierre Clavelou, PU-PH         
University Hospital of Lille Recruiting
Lille, France
Principal Investigator: Patrick Vermersch, PU-PH         
University Hospital of Marseille Recruiting
Marseille, France
Principal Investigator: Jean Pelletier, PU-PH         
University Hospital of Montpellier Recruiting
Montpellier, France
Principal Investigator: William Camu, PU-PH         
University Hospital of Nantes Recruiting
Nantes, France
Principal Investigator: David Laplaud, PH         
Sub-Investigator: Mohamed Hamidou, PU-PH         
University Hospital of Nice Recruiting
Nice, France
Principal Investigator: Christine Lebrun, PH         
University Hospital of Rennes Recruiting
Rennes, France
Principal Investigator: Gilles Edan, PU-PH         
University Hospital of Strasbourg Recruiting
Strasbourg, France
Principal Investigator: Jerôme de Seze, Pu-PH         
University Hospital of Toulouse Recruiting
Toulouse, France
Principal Investigator: Didier Brassat, PH         
Sponsors and Collaborators
Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01723631     History of Changes
Other Study ID Numbers: 10/06-S, 2010-A00892-37
Study First Received: November 6, 2012
Last Updated: November 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Multiple sclerosis
TRAP
TRAP-Myéline

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014