Multiple Sclerosis Clinical Trial
— POLAROfficial 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)
NCT number | NCT02043964 |
Other study ID # | RC-P0021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | December 2018 |
Verified date | March 2024 |
Source | Lille Catholic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University |
France,
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 |
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