Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723631

Acronym

TRAP-Myéline

Enrollment

189

Registered

2012-11-08

Start date

2012-04-30

Completion date

2015-10-31

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, TRAP, TRAP-Myéline

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,

Interventions

DEVICETrap Myelin Test

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis	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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026