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:
Nantes University Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
multiple sclerosis
tumor necrosis factor receptor-associated periodic syndrome
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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 June 13, 2013