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

Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome
• Intervention / Treatment: Procedure: tears and cerebrospinal fluid sampling

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33300
    • Centre hospitalier Universitaire de Bordeaux
  • Caen, France, 14000
    • Centre Hospitalier Universitaire Caen
  • Clermont-Ferrand, France, 63000
    • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Dijon, France, 21000
    • Centre Hospitalier Universitaire De Dijon
  • Lille, France, 59000
    • Centre Hospitalier Régional Universitaire de Lille
  • Lomme, France, 59 462
    • Groupe Hospitalier de l'Institut Catholique de Lille
  • Lyon, France, 69000
    • Centre Hospitalier Universitaire de Lyon
  • Marseille, France, 13000
    • Hopital de la Timone
  • Nancy, France, 54100
    • Universitaire de Nancy
  • Nantes, France, 44200
    • Centre Hospitalier Universitaire de Nantes
  • Nice, France, 6200
    • Centre Hospitalier Universitaire de Nice
  • Poissy, France, 78300
    • Centre Hospitalier Intercommunal Poissy-St-Germain
  • Rouen, France, 76100
    • Centre Hospitalier Univetrsitaire de Rouen
  • Strasbourg, France, 67100
    • Centre Hospitalier Régional Universitaire de Strasbourg
  • Valenciennes, France, 59300
    • Centre hospitalier de valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tears and cerebro-spinal fluid sampling	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid	Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid	two years after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	two years
Calculation of sensitivity/specificity	Calculation of sensitivity/specificity	two years
Calculation of positive/negative predictive value	Calculation of positive/negative predictive value	two years
Calculation of efficiency odds ratio	Calculation of efficiency odds ratio	two years

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Patrick Vermersch, MD, PhD, Centre Hospitalier Régional, Universitaire de Lille; Principal Investigator: Jérôme de Seze, MD, PhD, Centre Hospitalier Régional Universitaire de Strasbourg; Principal Investigator: Marc Debouverie, MD, PhD, Central Hospital, Nancy, France; Principal Investigator: Bruno Brochet, MD, PhD, University Hospital, Bordeaux; Study Director: Gérard Forzy, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille; Principal Investigator: Patrick Hautecoeur, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille; Principal Investigator: Gilles Defer, MD, Centre Hospitalier Universitaire Caen; Principal Investigator: Christine Lebrun-Fresnay, MD, PhD, Centre Hospitalier Universitaire de Nice; Principal Investigator: Thibault Moreau, MD, Centre Hospitalier Universitaire Dijon; Principal Investigator: Pierre Clavelou, MD, University Hospital, Clermont-Ferrand; Principal Investigator: Olivier Heinzlef, MD, Centre Hospitalier Intercommunal Poissy-St-Germain; Principal Investigator: Christian Confavreux, MD, Centre Hospitalier Universitaire de Lyon; Principal Investigator: Jean Pelletier, MD, PhD, Hopital de la Timone, Marseille; Principal Investigator: Sandrine Wiertlewski, MD, Nantes University Hospital; Principal Investigator: Albert Verier, MD, Centre hospitalier de valenciennes; Principal Investigator: Bertrand Bourre, MD, Centre Hospitalier Universitaire de Rouen

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimated): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Clinically Isolated Syndrome; Tears; Isoelectric focusing; Oligoclonal profile
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease; Multiple Sclerosis; Sclerosis; Syndrome
• Other Study ID Numbers: RC-P0021