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

NCT ID: NCT02043964

Last Updated: 2024-03-26

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

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Clinically Isolated Syndrome 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 and cerebro-spinal fluid sampling

Group Type EXPERIMENTAL

tears and cerebrospinal fluid sampling

Intervention Type PROCEDURE

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.

Interventions

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tears and cerebrospinal fluid sampling

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gérard Forzy, MD

Role: STUDY_DIRECTOR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Patrick Hautecoeur, MD

Role: PRINCIPAL_INVESTIGATOR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Patrick Vermersch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional, Universitaire de Lille

Gilles Defer, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Caen

Christine Lebrun-Fresnay, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Jérôme de Seze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional Universitaire de Strasbourg

Thibault Moreau, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Dijon

Pierre Clavelou, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Olivier Heinzlef, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Intercommunal Poissy-St-Germain

Christian Confavreux, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Lyon

Marc Debouverie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Jean Pelletier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital de la Timone, Marseille

Bruno Brochet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Sandrine Wiertlewski, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Albert Verier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Valenciennes

Bertrand Bourre, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Site Status

Centre Hospitalier Universitaire Caen

Caen, , France

Site Status

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Universitaire de Dijon

Dijon, , France

Site Status

Centre Hospitalier Régional Universitaire de Lille

Lille, , France

Site Status

Groupe Hospitalier de l'Institut Catholique de Lille

Lomme, , France

Site Status

Centre Hospitalier Universitaire de Lyon

Lyon, , France

Site Status

Hopital de la Timone

Marseille, , France

Site Status

Universitaire de Nancy

Nancy, , France

Site Status

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status

Centre Hospitalier Universitaire de Nice

Nice, , France

Site Status

Centre Hospitalier Intercommunal Poissy-St-Germain

Poissy, , France

Site Status

Centre Hospitalier Univetrsitaire de Rouen

Rouen, , France

Site Status

Centre Hospitalier Régional Universitaire de Strasbourg

Strasbourg, , France

Site Status

Centre Hospitalier de Valenciennes

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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RC-P0021

Identifier Type: -

Identifier Source: org_study_id

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