Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

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,

Full Title of Study: “Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

Interventions

  • Device: Trap Myelin Test

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Other: secondary progressive multiple sclerosis- Group 3
    • Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis
  • Other: primary progressive multiple sclerosis- group 4
    • Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis
  • Other: control 1
    • healthy volunteers
  • Other: Control 2
    • Patients with central or peripheral neurological non-inflammatory, non-autoimmune.
  • Other: Control 3
    • Patients having an autoimmune pathology

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Collaborator
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.