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

Multiple Sclerosis Clinical Trial

— POLAR  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043964
• Other study ID #: RC-P0021
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2018

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Sclerosis
• Syndrome

Intervention

Procedure:
• tears and cerebrospinal fluid sampling
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Centre Hospitalier Universitaire Caen	Caen
France	Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-Ferrand
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Centre Hospitalier Régional Universitaire de Lille	Lille
France	Groupe Hospitalier de l'Institut Catholique de Lille	Lomme
France	Centre Hospitalier Universitaire de Lyon	Lyon
France	Hopital de la Timone	Marseille
France	Universitaire de Nancy	Nancy
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Centre Hospitalier Universitaire de Nice	Nice
France	Centre Hospitalier Intercommunal Poissy-St-Germain	Poissy
France	Centre Hospitalier Univetrsitaire de Rouen	Rouen
France	Centre Hospitalier Régional Universitaire de Strasbourg	Strasbourg
France	Centre Hospitalier de Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

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