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Tear Analysis in the Diagnosis of Multiple Sclerosis (LARMES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT02016222
First received: November 22, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Primary Progressive Multiple Sclerosis
Procedure: tears sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Lille Catholic University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isoelectrophoretic profile of tears [ Time Frame: Baseline and two years after inclusion ] [ Designated as safety issue: No ]
    Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.

  • Isoelectrophoretic profiles of tears by digital recording and analysis of images [ Time Frame: Baseline and two years after ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tears sampling Procedure: tears sampling

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016222

Locations
France
Centre hospitalier universitaire (CHU), Nice
Nice, Alpes Maritimes, France, 06003
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Lille, Nord, France, 59000
Centre hospitaliere universitaire
Bordeaux, France, 33404
Centre hospitalier universitaire
Caen, France, 14033
Centre hospitalier régional universitaire
Clermont-Ferrand, France, 63003
Centre hospitalier universitaire
Dijon, France, 21079
Centre hospitalier régional universitaire
Lille, France, 59037
Hospices civils de Lyon
Lyon, France, 69229
Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13354
Centre hospitalier universitaire
Nancy, France, 54035
Centre hospitalier universitaire
Nimes, France, 30029
Centre hospitalier intercommunal
Poissy, France, 78303
Centre hospitalier régional universtaire
Strasbourg, France, 67091
Sponsors and Collaborators
Lille Catholic University
Bayer
Investigators
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: Jérome De Sèze, MD, PhD Centre Hospitalier Régional Universitaire de Strasbourg
Principal Investigator: Thibaut Moreau, MD Centre Hospitalier Universitaire de 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: Christian Confavreux, MD Hospices Civils de Lyon
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 Centre Hospitalier Universitaire de Bordeaux
Principal Investigator: Gilles Defer, MD Centre Hospitalier Universitaire de Caen
Principal Investigator: Eric Thouvenot, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02016222     History of Changes
Other Study ID Numbers: RC-P0006
Study First Received: November 22, 2013
Last Updated: August 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by Lille Catholic University:
primary progressive multiple sclerosis
diagnosis
tears
isoelectric focusing
oligoclonal bands

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014