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Completed

NCT Number: NCT02043964

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

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.

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Key information

Conditions

Clinically Isolated Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Lacerations Multiple Sclerosis Nervous System Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tears and cerebrospinal fluid sampling

Procedure

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 outcomes

  1. Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid

    Time frame: two years after

    Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid

Secondary outcomes

  1. Diagnostic performance of isoelectric focusing of tears

    Time frame: 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

  2. Concordance between visual and automatic reading of electrophoretic profiles

    Time frame: two years

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

  3. Calculation of sensitivity/specificity

    Time frame: two years

    Calculation of sensitivity/specificity

  4. Calculation of positive/negative predictive value

    Time frame: two years

    Calculation of positive/negative predictive value

  5. Calculation of efficiency odds ratio

    Time frame: two years

    Calculation of efficiency odds ratio

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study 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)

Acronym: POLAR

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2014
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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