Tear Analysis in the Diagnosis of Multiple Sclerosis (LARMES)

September 19, 2016 updated by: Lille Catholic University

Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

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.

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.

Detailed Description

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.

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.
80

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, 33404
        • Centre hospitaliere universitaire
      • Caen, France, 14033
        • Centre Hospitalier Universitaire
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Régional Universitaire
      • Dijon, France, 21079
        • Centre Hospitalier Universitaire
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire
      • Lyon, France, 69229
        • Hospices Civils de Lyon
      • Marseille, France, 13354
        • Assistance Publique - Hopitaux de Marseille
      • Nancy, France, 54035
        • Centre Hospitalier Universitaire
      • Nimes, France, 30029
        • Centre Hospitalier Universitaire
      • Poissy, France, 78303
        • Centre Hospitalier Intercommunal
      • Strasbourg, France, 67091
        • Centre hospitalier régional universtaire
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06003
        • Centre hospitalier universitaire (CHU), Nice
    • Nord
      • Lille, Nord, France, 59000
        • Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

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

Genders Eligible for Study

All

Description

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

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 sampling
Procedure: tears sampling

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
Time Frame
Concordance between the quantification of oligoclonal IgG bands by isoelectric focusing in tears and in the cerebrospinal fluid in patients with primary progressive multiple sclerosis
Time Frame: at baseline and two years after (+/- 2 months)
at baseline and two years after (+/- 2 months)

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
Isoelectrophoretic profile of tears
Time Frame: Baseline and two years after inclusion
Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.
Baseline and two years after inclusion
Isoelectrophoretic profiles of tears by digital recording and analysis of images
Time Frame: Baseline and two years after
Baseline and two years after

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

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: Christian Confavreux, MD, Hospices Civils de Lyon
  • Principal Investigator: Patrick Hautecoeur, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
  • Study Chair: Elisabeth Baumelou, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille
  • Principal Investigator: Patrick Vermersch, MD, PhD, Centre Hospitalier Régional, Universitaire de Lille
  • Principal Investigator: Christine Lebrun-Frenay, MD, PhD, Centre Hospitalier Universitaire de Nice
  • Principal Investigator: Jérôme de Seze, MD, PhD, Centre Hospitalier Régional Universitaire de Strasbourg
  • Principal Investigator: Thibaut Moreau, MD, Centre Hospitalier Universitaire Dijon
  • Principal Investigator: Pierre Clavelou, MD, Centre Hospitalier Régional Universitaire de Clermont-Ferrand
  • Principal Investigator: Olivier Heinzlef, MD, Centre Hospitalier Intercommunal de Poissy
  • Principal Investigator: Marc Debouverie, MD, PhD, Central Hospital, Nancy, France
  • Principal Investigator: Jean Pelletier, MD, PhD, L'assistance Publique des Hôpitaux de Marseille
  • Principal Investigator: Bruno Brochet, MD, PhD, University Hospital, Bordeaux
  • Principal Investigator: Gilles Defer, MD, Centre Hospitalier Universitaire de Caen
  • Principal Investigator: Eric Thouvenot, MD, Centre Hospitalier Universitaire de Nīmes

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.
April 1, 2011

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.
March 1, 2016

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.
March 1, 2016

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.
December 18, 2013

First Posted (Estimate)

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.
December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
September 20, 2016

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.
September 19, 2016

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.
September 1, 2016

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-P0006

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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