Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
54000 participants
OBSERVATIONAL
2011-01-31
2019-12-31
Brief Summary
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In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are
* To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
* To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
* To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
* To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
* To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
* To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
* To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Radiologically Isolated Syndromes (RIS)
No interventions assigned to this group
Clinically Isolated Syndromes (RIS)
No interventions assigned to this group
Primary progressive MS (PPMS)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* CIS
* MS according to McDonald 2010 criteria
* NMOSD and others as per NOMADMUS criteria
* No age limt
* All clinical courses
* Domiciliated in France
* Signed OFSEP informed consent
Exclusion Criteria
\-
100 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Sandra VUKUSIC
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer
Bron, , France
Countries
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Central Contacts
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References
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Gavoille A, Rollot F, Casey R, Debouverie M, Le Page E, Ciron J, De Seze J, Ruet A, Maillart E, Labauge P, Zephir H, Papeix C, Defer G, Lebrun-Frenay C, Moreau T, Laplaud DA, Berger E, Stankoff B, Clavelou P, Thouvenot E, Heinzlef O, Pelletier J, Al Khedr A, Casez O, Bourre B, Cabre P, Wahab A, Magy L, Camdessanche JP, Maurousset A, Moulin S, Ben NH, Boulos DD, Hankiewicz K, Neau JP, Pottier C, Nifle C, Rabilloud M, Subtil F, Vukusic S; Observatoire Francais de la Sclerose en Plaques (OFSEP) Investigators. Investigating the Long-term Effect of Pregnancy on the Course of Multiple Sclerosis Using Causal Inference. Neurology. 2023 Mar 21;100(12):e1296-e1308. doi: 10.1212/WNL.0000000000206774. Epub 2022 Dec 23.
Signori A, Lorscheider J, Vukusic S, Trojano M, Iaffaldano P, Hillert J, Hyde R, Pellegrini F, Magyari M, Koch-Henriksen N, Sorensen PS, Spelman T, van der Walt A, Horakova D, Havrdova E, Girard M, Eichau S, Grand'Maison F, Gerlach O, Terzi M, Ozakbas S, Skibina O, Van Pesch V, Sa MJ, Prevost J, Alroughani R, McCombe PA, Gouider R, Mrabet S, Castillo-Trivino T, Zhu C, de Gans K, Sanchez-Menoyo JL, Yamout B, Khoury S, Sormani MP, Kalincik T, Butzkueven H; Big MS Data Network. Heterogeneity on long-term disability trajectories in patients with secondary progressive MS: a latent class analysis from Big MS Data network. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):23-30. doi: 10.1136/jnnp-2022-329987. Epub 2022 Sep 28.
Other Identifiers
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69HCL14_0385
Identifier Type: -
Identifier Source: org_study_id
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