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

Primary Purpose

Clinically Isolated Syndrome, Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

tears and cerebrospinal fluid sampling

About this trial

This is an interventional diagnostic trial for Clinically Isolated Syndrome focused on measuring Multiple Sclerosis, Clinically Isolated Syndrome, Tears, Isoelectric focusing, Oligoclonal profile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tears and cerebro-spinal fluid sampling

Arm Description

Outcomes

Primary Outcome Measures

Concordance between the quantification of oligoclonal IgG bands in tears and in cerebrospinal fluid by isoelectric focusing in patients with clinically isolated syndrome

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02043964

First Posted

November 22, 2013

Last Updated

September 12, 2023

Sponsor

Lille Catholic University

1. Study Identification

Unique Protocol Identification Number

NCT02043964

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lille Catholic University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinically Isolated Syndrome, Multiple Sclerosis

Keywords

Multiple Sclerosis, Clinically Isolated Syndrome, Tears, Isoelectric focusing, Oligoclonal profile

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tears and cerebro-spinal fluid sampling

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

tears and cerebrospinal fluid sampling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Concordance between the quantification of oligoclonal IgG bands in tears and in cerebrospinal fluid by isoelectric focusing in patients with clinically isolated syndrome

Time Frame

two years after

Secondary Outcome Measure Information:

Title

Diagnostic performance of isoelectric focusing of tears

Description

Identification of the number of patients with a typical electrophoretic profile in tears allowing the early diagnosis of a SEP-RR

Time Frame

inclusion, two years after

Title

Concordance between visual and automatic reading of electrophoretic profiles

Description

Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: