Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion

N/ACompletedNCT02043964

Lille Catholic University165 enrolled

Overview

This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

165

Conditions

Clinically Isolated Syndrome Multiple Sclerosis

Interventions

All patients recruited in this study will undergo a cerebrospinal fluid sampling which is an invasive procedure included in the actual routine practice. In addition a sampling from eyes will be obtain using the Schirmer test to get tears from the lacrimal gland.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old or more * Clinically isolated syndrome of less than 3 months of onset * Informed consent to participate Exclusion Criteria: * Progressive primary multiple sclerosis * Relapsing remitting multiple sclerosis * Persons wearing contact lenses * Ocular Infection * Corticoid treatment at least 30 days before sampling * Immunosuppressive or immunomodulatory treatment at least 3 months before sampling * Pregnancy or breast feeding * No coverage by the Social Insurance

Locations (15)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

Centre Hospitalier Universitaire Caen

Caen, France

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Centre Hospitalier Universitaire de Dijon

Dijon, France

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Groupe Hospitalier de l'Institut Catholique de Lille

Lomme, France

Centre Hospitalier Universitaire de Lyon

Lyon, France

Hopital de la Timone

Marseille, France

Universitaire de Nancy

Nancy, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

...and 5 more locations

Outcomes

Primary Outcomes

Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid

Time frame: two years after

Secondary Outcomes

Diagnostic performance of isoelectric focusing of tears

Identification of the number of patients with a typical electrophoretic profile in tears allowing the early diagnosis of a SEP-RR

Time frame: inclusion, two years after

Concordance between visual and automatic reading of electrophoretic profiles

Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles

Time frame: two years

Calculation of sensitivity/specificity

Time frame: two years

Calculation of positive/negative predictive value

Time frame: two years

Calculation of efficiency odds ratio

Time frame: two years