Clinical trial NCT02043964: Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinically Isolated Syndrome
Multiple Sclerosis
Keywords: Multiple Sclerosis
Clinically Isolated Syndrome
Tears
Isoelectric focusing
Oligoclonal profile
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
timeFrame: two years after
Secondary outcomes:
measure: Diagnostic performance of isoelectric focusing of tears
timeFrame: inclusion, two years after
measure: Concordance between visual and automatic reading of electrophoretic profiles
timeFrame: two years
measure: Calculation of sensitivity/specificity
timeFrame: two years
measure: Calculation of positive/negative predictive value
timeFrame: two years
measure: Calculation of efficiency odds ratio
timeFrame: two years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Caen
country: France
facility: Centre Hospitalier Universitaire Caen
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Lomme
country: France
facility: Groupe Hospitalier de l'Institut Catholique de Lille
city: Lyon
country: France
facility: Centre Hospitalier Universitaire de Lyon
city: Marseille
country: France
facility: Hopital de la Timone
city: Nancy
country: France
facility: Universitaire de Nancy
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal Poissy-St-Germain
city: Rouen
country: France
facility: Centre Hospitalier Univetrsitaire de Rouen
city: Strasbourg
country: France
facility: Centre Hospitalier Régional Universitaire de Strasbourg
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Gérard Forzy, MD
role: STUDY_DIRECTOR
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Patrick Hautecoeur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Régional, Universitaire de Lille
name: Patrick Vermersch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Caen
name: Gilles Defer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nice
name: Christine Lebrun-Fresnay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Régional Universitaire de Strasbourg
name: Jérôme de Seze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Thibault Moreau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Pierre Clavelou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Intercommunal Poissy-St-Germain
name: Olivier Heinzlef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Lyon
name: Christian Confavreux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Marc Debouverie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de la Timone, Marseille
name: Jean Pelletier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Bruno Brochet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Sandrine Wiertlewski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Valenciennes
name: Albert Verier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Bertrand Bourre, MD
role: PRINCIPAL_INVESTIGATOR
References: