Tear Analysis in the Diagnosis of Multiple Sclerosis

NCT02016222 | Completed

• 1 other identifier: RC-P0006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Primary Progressive Multiple Sclerosis

Keywords

primary progressive multiple sclerosis; diagnosis; tears; isoelectric focusing; oligoclonal bands

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline and two years after (+/- 2 months)

Secondary Outcomes (2)

• Isoelectrophoretic profile of tears

  Baseline and two years after inclusion

• Isoelectrophoretic profiles of tears by digital recording and analysis of images

  Baseline and two years after

Study Arms (1)

Tears sampling

EXPERIMENTAL

Procedure: tears sampling

Interventions

tears sampling PROCEDURE

Tears sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• Bayer: collaborator

Study Sites (13)

Centre hospitalier universitaire (CHU), Nice

Nice, Alpes Maritimes, 06003, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

Lille, Nord, 59000, France

Location

Centre hospitaliere universitaire

Bordeaux, 33404, France

Location

Centre hospitalier universitaire

Caen, 14033, France

Location

Centre hospitalier régional universitaire

Clermont-Ferrand, 63003, France

Location

Centre hospitalier universitaire

Dijon, 21079, France

Location

Centre hospitalier régional universitaire

Lille, 59037, France

Location

Hospices civils de Lyon

Lyon, 69229, France

Location

Assistance Publique - Hôpitaux de Marseille

Marseille, 13354, France

Location

Centre hospitalier universitaire

Nancy, 54035, France

Location

Centre hospitalier universitaire

Nîmes, 30029, France

Location

Centre hospitalier intercommunal

Poissy, 78303, France

Location

Centre hospitalier régional universtaire

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Disease; Lacerations

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Patrick Hautecoeur, MD

  Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

  PRINCIPAL INVESTIGATOR

• Elisabeth Baumelou, MD

  Groupement des Hôpitaux de l'Institut Catholique de Lille

  STUDY CHAIR

• 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 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

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Gilles Defer, MD

  Centre Hospitalier Universitaire de Caen

  PRINCIPAL INVESTIGATOR

• Eric Thouvenot, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 19, 2013
• Study Start: April 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

FR (13)