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

NCT02043964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-03-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Gérard Forzy, MD · Groupement des Hôpitaux de l'Institut Catholique de Lille

  • Patrick Hautecoeur, MD · Groupement des Hôpitaux de l'Institut Catholique de Lille

  • Patrick Vermersch, MD, PhD · Centre Hospitalier Régional, Universitaire de Lille

  • Gilles Defer, MD · Centre Hospitalier Universitaire Caen

  • Christine Lebrun-Fresnay, MD, PhD · Centre Hospitalier Universitaire de Nice

  • Jérôme de Seze, MD, PhD · Centre Hospitalier Régional Universitaire de Strasbourg

  • Thibault Moreau, MD · Centre Hospitalier Universitaire Dijon

  • Pierre Clavelou, MD · University Hospital, Clermont-Ferrand

  • Olivier Heinzlef, MD · Centre Hospitalier Intercommunal Poissy-St-Germain

  • Christian Confavreux, MD · Centre Hospitalier Universitaire de Lyon

  • Marc Debouverie, MD, PhD · Central Hospital, Nancy, France

  • Jean Pelletier, MD, PhD · Hopital de la Timone, Marseille

  • Bruno Brochet, MD, PhD · University Hospital, Bordeaux

  • Sandrine Wiertlewski, MD · Nantes University Hospital

  • Albert Verier, MD · Centre Hospitalier de Valenciennes

  • Bertrand Bourre, MD · University Hospital, Rouen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02043964 on ClinicalTrials.gov