Informations générales (source: ClinicalTrials.gov)

NCT04028232 Statut inconnu
Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS). (ECOVIMUS)
Observational [Patient Registry]
  • Sclérose en plaques
  • Sclérose
University Hospital, Caen (Voir sur ClinicalTrials)
juillet 2019
décembre 2020
29 juin 2024
Background: In comparison to general population, persons with Multiple Sclerosis have a higher risk to premature death with an estimate reduced life expectancy from 7 to 14 years. However, risk factors of mortality in MS are not well identified and well known. Following the example of studies carry on cancers survival, socioeconomic status (SES) may have an influence on survival in MS. Objective: The main objective of ECOVIMUS is to estimate net survival according to SES using the European Deprivation Index as a proxy and other major covariates (gender, initial clinical phase and years of disease onset). Methods: In order to answer to our main objective, we will use a retrospective cohort of MS patients with a medical follow-up in one of the 18 centers included in SURVIMUS II, with a MS onset between 1960 and 2015 and with an informed vital at the date of December 31st, 2015. The ecological score of deprivation EDI will be used as a proxy of the socioeconomic status and will be attributed from the geolocalisation to patient's residence address. Net survival is directly associated to the notion of "mortality in excess". This mortality will be estimated comparing the observed mortality in MS patients to mortality in the general population. The advantage of this methodological approach is that cause of death is not needed. Statistical analysis: The influence of socioeconomic status on the excess of mortality will be estimated thanks to a parametric multivariate model of excess rate mortality. This model will be adjusted on other major covariates (gender, age at disease onset, and initial clinical phase) and will include potential complex effects as non-linearity, non-proportionality and interactions. Expected results: We expect to highlight some differences of net survival in MS patients according to socioeconomic group as it was already shown in cancers. This study will complete information on factors of mortality excess in MS and knowledge on socioeconomic inequalities encountered all along MS disease course.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
University Hospital Centre of Toulouse - Toulouse - France David BRASSAT, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Besancon - Besançon - France Eric BERGER, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Lille - Lille - France Patrick VERMERSCH, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Lyon - Lyon - France Sandra VUKUSIC En recrutement Contact (sur clinicalTrials)
University Hospital of Montpellier - Montpellier - France LABAUGE Pierre, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Nancy - Nancy - France Marc DEBOUVERIE, Professor En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
University Hospital Center of CAEN - 14033 - Caen - Normandy - France Gilles-Louis DEFER, Professor En recrutement Contact (sur clinicalTrials)
University Hospital Centre of Caen - Caen - France Gilles-Louis DEFER, Professor En recrutement Contact (sur clinicalTrials)
University hospital Centre of Nîmes - Nîmes - France Giovanni CASTELNOVO, Professor En recrutement Contact (sur clinicalTrials)
University Hospital Centre of Saint-Etienne - Saint-Étienne - France Jean-phillipe CAMDESSANCHE, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Bordeaux - Bordeaux - France Bruno BROCHET, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Clermont Ferrand - Clermont-Ferrand - France Pierre CLAVELOU, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Dijon - Dijon - France Thibault MOREAU, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Marseille - Marseille - France Jean PELLETIER, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Nantes - Nantes - France David LAPLAUD, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Nice - Nice - France Christine LEBRUN-FRENAY, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Rennes - Rennes - France Gilles EDAN, Professor En recrutement Contact (sur clinicalTrials)
University Hospital of Strasbourg - Strasbourg - France Jérôme DE SEZE, Professor En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- all patients registered in 17 selected French OFSEP centres with core dataset with a
sufficient level of data

- Diagnosis a of definite or probably MS according to Poser or McDonald criteria. With
an MS onset date between January 1st, 1960 and December 31st, 2015.

- With a postal residence address well informed in the OFSEP database.



- MS patients with less than one year's disease duration by the study end will be
excluded.