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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tears and cerebro-spinal fluid sampling | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Concordance between visual and automatic reading of electrophoretic profiles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gérard Forzy, MD | Groupement des Hôpitaux de l'Institut Catholique de Lille | Study Director |
| Patrick Hautecoeur, MD | Groupement des Hôpitaux de l'Institut Catholique de Lille | Principal Investigator |
| Patrick Vermersch, MD, PhD | Centre Hospitalier Régional, Universitaire de Lille | Principal Investigator |
| Gilles Defer, MD | Centre Hospitalier Universitaire de Caen | Principal Investigator |
| Christine Lebrun-Fresnay, MD, PhD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Jérôme de Seze, MD, PhD | Centre Hospitalier Régional Universitaire de Strasbourg | Principal Investigator |
| Thibault Moreau, MD | Centre Hospitalier Universitaire Dijon | Principal Investigator |
| Pierre Clavelou, MD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Olivier Heinzlef, MD | Centre Hospitalier Intercommunal Poissy-St-Germain |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33300 | France | |||
| Centre Hospitalier Universitaire Caen |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2026 | |
| Reset | May 5, 2026 | |
| Release | May 19, 2026 |
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|
Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles |
| two years |
| Calculation of sensitivity/specificity | Calculation of sensitivity/specificity | two years |
| Calculation of positive/negative predictive value | Calculation of positive/negative predictive value | two years |
| Calculation of efficiency odds ratio | Calculation of efficiency odds ratio | two years |
| Principal Investigator |
| Christian Confavreux, MD | Centre Hospitalier Universitaire de Lyon | Principal Investigator |
| Marc Debouverie, MD, PhD | Central Hospital, Nancy, France | Principal Investigator |
| Jean Pelletier, MD, PhD | Hopital de la Timone, Marseille | Principal Investigator |
| Bruno Brochet, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Sandrine Wiertlewski, MD | Nantes University Hospital | Principal Investigator |
| Albert Verier, MD | Centre Hospitalier de Valenciennes | Principal Investigator |
| Bertrand Bourre, MD | University Hospital, Rouen | Principal Investigator |
| Caen |
| 14000 |
| France |
| Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Universitaire de Dijon | Dijon | 21000 | France |
| Centre Hospitalier Régional Universitaire de Lille | Lille | 59000 | France |
| Groupe Hospitalier de l'Institut Catholique de Lille | Lomme | 59 462 | France |
| Centre Hospitalier Universitaire de Lyon | Lyon | 69000 | France |
| Hopital de la Timone | Marseille | 13000 | France |
| Universitaire de Nancy | Nancy | 54100 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44200 | France |
| Centre Hospitalier Universitaire de Nice | Nice | 6200 | France |
| Centre Hospitalier Intercommunal Poissy-St-Germain | Poissy | 78300 | France |
| Centre Hospitalier Univetrsitaire de Rouen | Rouen | 76100 | France |
| Centre Hospitalier Régional Universitaire de Strasbourg | Strasbourg | 67100 | France |
| Centre Hospitalier de Valenciennes | Valenciennes | 59300 | France |
| Reset | Jun 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2026 | May 5, 2026 | |||
| May 19, 2026 | Jun 16, 2026 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |
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