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

March 25, 2024 updated by: Lille Catholic University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
Time Frame: two years after
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
two years after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic performance of isoelectric focusing of tears
Time Frame: inclusion, two years after
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
Time Frame: two years
Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles
two years
Calculation of sensitivity/specificity
Time Frame: two years
Calculation of sensitivity/specificity
two years
Calculation of positive/negative predictive value
Time Frame: two years
Calculation of positive/negative predictive value
two years
Calculation of efficiency odds ratio
Time Frame: two years
Calculation of efficiency odds ratio
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lille Catholic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC-P0021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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