Study Stopped
The number of patients achieved is sufficient to evaluate the diagnostic performance of the test TRAP-myelin
Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
TRAP-Myéline
Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
2 other identifiers
interventional
189
1 country
11
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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Apr 2012
Longer than P75 for not_applicable multiple-sclerosis
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
November 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 16, 2017
December 1, 2014
2.7 years
November 6, 2012
May 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Secondary Outcomes (1)
Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated
2 years
Study Arms (7)
Relapsing Multiple Sclerosis- group 1
OTHERDefinite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.
Relapsing Multiple Sclerosis- group 2
OTHERMultiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.
secondary progressive multiple sclerosis- Group 3
OTHERMultiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis
primary progressive multiple sclerosis- group 4
OTHERMultiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis
control 1
OTHERhealthy volunteers
Control 2
OTHERPatients with central or peripheral neurological non-inflammatory, non-autoimmune.
Control 3
OTHERPatients having an autoimmune pathology
Interventions
Eligibility Criteria
You may qualify if:
- These criteria depend on the subgroup belongs to the patient.
- Signed consent
- Membership of a social security system
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University Hospital of Bordeaux
Bordeaux, France
Hopital neurologigue Pierre Wertheimer
Bron, France
University Hospital of clermont Ferrand
Clermont-Ferrand, France
University Hospital of Lille
Lille, France
University Hospital of Marseille
Marseille, France
University Hospital of Montpellier
Montpellier, France
University Hospital of Nantes
Nantes, France
University Hospital of Nice
Nice, France
University Hospital of Rennes
Rennes, France
University Hospital of Strasbourg
Strasbourg, France
University Hospital of Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2012
First Posted
November 8, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2014
Study Completion
October 1, 2015
Last Updated
May 16, 2017
Record last verified: 2014-12