Tear Analysis in the Diagnosis of Multiple Sclerosis

NCT ID: NCT02016222

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-03-31

Brief Summary

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In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.

Detailed Description

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The objective of the present study is to assess concordance between oligoclonal bands detection in tears and in cerebrospinal fluid. We will include patients with primary progressive multiple sclerosis and we will compare results of oligoclonal bands detection by isoelectric focusing in cerebrospinal fluid and tears. Tears will be collected using a Schirmer strip. This would circumvent the practice of invasive lumbar punctures currently used in multiple sclerosis diagnosis.

Conditions

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Primary Progressive Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tears sampling

Group Type EXPERIMENTAL

tears sampling

Intervention Type PROCEDURE

Interventions

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tears sampling

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years old or more
* Progressive neurological deficit after 12 months
* At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions)

Exclusion Criteria

* Asiatic persons
* recurrent forms of the disease
* Persons wearing contact lenses
* Ocular Infection
* Corticoid treatment at least 30 days before sampling
* immunosuppressive or immunomodulatory treatment 3 months before sampling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Hautecoeur, MD

Role: PRINCIPAL_INVESTIGATOR

Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

Elisabeth Baumelou, MD

Role: STUDY_CHAIR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Patrick Vermersch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional, Universitaire de Lille

Christine Lebrun-Frenay, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Jérome De Sèze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional Universitaire de Strasbourg

Thibaut Moreau, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Dijon

Pierre Clavelou, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional Universitaire de Clermont-Ferrand

Olivier Heinzlef, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier intercommunal de Poissy

Christian Confavreux, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Marc Debouverie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Jean Pelletier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

L'assistance Publique des Hôpitaux de Marseille

Bruno Brochet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Gilles Defer, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Caen

Eric Thouvenot, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre hospitalier universitaire (CHU), Nice

Nice, Alpes Maritimes, France

Site Status

Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

Lille, Nord, France

Site Status

Centre hospitaliere universitaire

Bordeaux, , France

Site Status

Centre hospitalier universitaire

Caen, , France

Site Status

Centre hospitalier régional universitaire

Clermont-Ferrand, , France

Site Status

Centre hospitalier universitaire

Dijon, , France

Site Status

Centre hospitalier régional universitaire

Lille, , France

Site Status

Hospices civils de Lyon

Lyon, , France

Site Status

Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Site Status

Centre hospitalier universitaire

Nancy, , France

Site Status

Centre hospitalier universitaire

Nîmes, , France

Site Status

Centre hospitalier intercommunal

Poissy, , France

Site Status

Centre hospitalier régional universtaire

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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RC-P0006

Identifier Type: -

Identifier Source: org_study_id

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