Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— TRAP-Myéline  

Official title:

Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01723631
• Other study ID #: BRD/10/06-S
• Secondary ID: 2010-A00892-37
• Status: Terminated
• Phase: N/A
• First received: November 6, 2012
• Last updated: May 15, 2017
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 189
• Est. completion date: October 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Trap Myelin Test

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated		2 years