Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion
POLAR
1 other identifier
interventional
165
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 26, 2024
March 1, 2024
5.7 years
November 22, 2013
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
two years after
Secondary Outcomes (5)
Diagnostic performance of isoelectric focusing of tears
inclusion, two years after
Concordance between visual and automatic reading of electrophoretic profiles
two years
Calculation of sensitivity/specificity
two years
Calculation of positive/negative predictive value
two years
Calculation of efficiency odds ratio
two years
Study Arms (1)
tears and cerebro-spinal fluid sampling
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- years old or more
- Clinically isolated syndrome of less than 3 months of onset
- Informed consent to participate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33300, France
Centre Hospitalier Universitaire Caen
Caen, 14000, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Centre Hospitalier Universitaire de Dijon
Dijon, 21000, France
Centre Hospitalier Régional Universitaire de Lille
Lille, 59000, France
Groupe Hospitalier de l'Institut Catholique de Lille
Lomme, 59 462, France
Centre Hospitalier Universitaire de Lyon
Lyon, 69000, France
Hopital de la Timone
Marseille, 13000, France
Universitaire de Nancy
Nancy, 54100, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44200, France
Centre Hospitalier Universitaire de Nice
Nice, 6200, France
Centre Hospitalier Intercommunal Poissy-St-Germain
Poissy, 78300, France
Centre Hospitalier Univetrsitaire de Rouen
Rouen, 76100, France
Centre Hospitalier Régional Universitaire de Strasbourg
Strasbourg, 67100, France
Centre Hospitalier de Valenciennes
Valenciennes, 59300, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Patrick Vermersch, MD, PhD
Centre Hospitalier Régional, Universitaire 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
Jérôme de Seze, MD, PhD
Centre Hospitalier Régional Universitaire de Strasbourg
- 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
Marc Debouverie, MD, PhD
Central Hospital, Nancy, France
- PRINCIPAL INVESTIGATOR
Jean Pelletier, MD, PhD
Hopital de la Timone, Marseille
- PRINCIPAL INVESTIGATOR
Bruno Brochet, MD, PhD
University Hospital, Bordeaux
- PRINCIPAL INVESTIGATOR
Sandrine Wiertlewski, MD
Nantes University Hospital
- PRINCIPAL INVESTIGATOR
Albert Verier, MD
Centre Hospitalier de Valenciennes
- PRINCIPAL INVESTIGATOR
Bertrand Bourre, MD
University Hospital, Rouen
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
January 23, 2014
Study Start
October 1, 2012
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
March 26, 2024
Record last verified: 2024-03