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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trap Myelin Test
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Multiple sclerosis, TRAP, TRAP-Myéline

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University Hospital of Bordeaux
  • Hopital neurologigue Pierre Wertheimer
  • University Hospital of clermont Ferrand
  • University Hospital of Lille
  • University Hospital of Marseille
  • University Hospital of Montpellier
  • University Hospital of Nantes
  • University Hospital of Nice
  • University Hospital of Rennes
  • University Hospital of Strasbourg
  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Other

Other

Other

Other

Other

Other

Arm Label

Relapsing Multiple Sclerosis- group 1

Relapsing Multiple Sclerosis- group 2

secondary progressive multiple sclerosis- Group 3

primary progressive multiple sclerosis- group 4

control 1

Control 2

Control 3

Arm Description

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

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

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

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

healthy volunteers

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

Patients having an autoimmune pathology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2012
Last Updated
May 15, 2017
Sponsor
Nantes University Hospital
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01723631
Brief Title
Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
Acronym
TRAP-Myéline
Official Title
Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
The number of patients achieved is sufficient to evaluate the diagnostic performance of the test TRAP-myelin
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, TRAP, TRAP-Myéline

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relapsing Multiple Sclerosis- group 1
Arm Type
Other
Arm Description
Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.
Arm Title
Relapsing Multiple Sclerosis- group 2
Arm Type
Other
Arm Description
Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.
Arm Title
secondary progressive multiple sclerosis- Group 3
Arm Type
Other
Arm Description
Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis
Arm Title
primary progressive multiple sclerosis- group 4
Arm Type
Other
Arm Description
Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis
Arm Title
control 1
Arm Type
Other
Arm Description
healthy volunteers
Arm Title
Control 2
Arm Type
Other
Arm Description
Patients with central or peripheral neurological non-inflammatory, non-autoimmune.
Arm Title
Control 3
Arm Type
Other
Arm Description
Patients having an autoimmune pathology
Intervention Type
Device
Intervention Name(s)
Trap Myelin Test
Primary Outcome Measure Information:
Title
Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
Description
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 Outcome Measure Information:
Title
Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
University Hospital of Bordeaux
City
Bordeaux
Country
France
Facility Name
Hopital neurologigue Pierre Wertheimer
City
Bron
Country
France
Facility Name
University Hospital of clermont Ferrand
City
Clermont Ferrand
Country
France
Facility Name
University Hospital of Lille
City
Lille
Country
France
Facility Name
University Hospital of Marseille
City
Marseille
Country
France
Facility Name
University Hospital of Montpellier
City
Montpellier
Country
France
Facility Name
University Hospital of Nantes
City
Nantes
Country
France
Facility Name
University Hospital of Nice
City
Nice
Country
France
Facility Name
University Hospital of Rennes
City
Rennes
Country
France
Facility Name
University Hospital of Strasbourg
City
Strasbourg
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

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