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| Name | Class |
|---|---|
| Région Nord-Pas de Calais, France | OTHER |
| Amiens University Hospital | OTHER |
| Boulogne sur Mer Hospital Center | OTHER |
| Centre Hospitalier VALENCIENNES |
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Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients will part of the same follow-up study. | Experimental | All patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optic nerve MRI sequence | Other | Systematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal |
| Measure | Description | Time Frame |
|---|---|---|
| Optic nerve involvement defined by occurrence of a recent clinical episode of ON | assessed at baseline | |
| Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal) | assessed at baseline | |
| Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse | assessed every 6 months during 24 months | |
| Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm) | assessed at baseline | |
| Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS | assessed every 6 months during 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic optic nerve involvement will be defined by: - asymptomatic optic nerve T2 hypersignal detected on one or both optic nerve(s) - or by GCIPL-IETD,3pm measured by OCT - or by GCIPL-IETD≥3µm measured by OCT | Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination (M0, M6, M12, M18, M24) | assessed at baseline every 6 months during 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliette Bochu | Contact | 0320444145 | juliette.bochu@chu-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro | Recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| OTHER |
| Centre Hospitalier de Roubaix | OTHER |
| Centre Hospitalier de Lens | OTHER |
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| Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination | assessed at Month 0, Month 6, Month 12, Month 18, Month 24 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |