Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome
• Interventions: Procedure: tears and cerebrospinal fluid sampling

• Registration Number: NCT02043964
• Lead Sponsor: Lille Catholic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tears and cerebro-spinal fluid sampling	tears and cerebrospinal fluid sampling	-

Primary Outcome Measures

Name	Time	Method
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid	two years after	Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid

Secondary Outcome Measures

Name	Time	Method
Calculation of positive/negative predictive value	two years	Calculation of positive/negative predictive value
Diagnostic performance of isoelectric focusing of tears	inclusion, two years after	Identification of the number of patients with a typical electrophoretic profile in tears allowing the early diagnosis of a SEP-RR
Calculation of sensitivity/specificity	two years	Calculation of sensitivity/specificity
Concordance between visual and automatic reading of electrophoretic profiles	two years	Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles
Calculation of efficiency odds ratio	two years	Calculation of efficiency odds ratio

Trial Locations

Locations (15)

Centre Hospitalier Universitaire de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Centre Hospitalier Univetrsitaire de Rouen; 🇫🇷 Rouen, France

Centre Hospitalier Régional Universitaire de Strasbourg; 🇫🇷 Strasbourg, France

Centre Hospitalier Universitaire de Dijon; 🇫🇷 Dijon, France

Hopital de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Centre Hospitalier Universitaire Caen; 🇫🇷 Caen, France

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Universitaire de Nancy; 🇫🇷 Nancy, France

Groupe Hospitalier de l'Institut Catholique de Lille; 🇫🇷 Lomme, France

Centre Hospitalier Intercommunal Poissy-St-Germain; 🇫🇷 Poissy, France

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France

Centre Hospitalier de Valenciennes; 🇫🇷 Valenciennes, France