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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2024
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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