Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).

Last updated: January 22, 2020
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Memory Loss

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT04028232
18512
  • Ages 1-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • all patients registered in 17 selected French OFSEP centres with core dataset with asufficient level of data

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

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

Exclusion

Exclusion Criteria:

  • MS patients with less than one year's disease duration by the study end will beexcluded.

Study Design

Total Participants: 30000
Study Start date:
July 10, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • University Hospital Center of CAEN

    Caen, Normandy 14033
    France

    Active - Recruiting

  • University Hospital of Besancon

    Besançon,
    France

    Active - Recruiting

  • University Hospital of Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • University Hospital Centre of Caen

    Caen,
    France

    Active - Recruiting

  • University Hospital of Clermont Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • University Hospital of Dijon

    Dijon,
    France

    Active - Recruiting

  • University Hospital of Lille

    Lille,
    France

    Active - Recruiting

  • University Hospital of Lyon

    Lyon,
    France

    Active - Recruiting

  • University Hospital of Marseille

    Marseille,
    France

    Active - Recruiting

  • University Hospital of Montpellier

    Montpellier,
    France

    Active - Recruiting

  • University Hospital of Nancy

    Nancy,
    France

    Active - Recruiting

  • University Hospital of Nantes

    Nantes,
    France

    Active - Recruiting

  • University Hospital of Nice

    Nice,
    France

    Active - Recruiting

  • University hospital Centre of Nîmes

    Nîmes,
    France

    Active - Recruiting

  • University Hospital of Rennes

    Rennes,
    France

    Active - Recruiting

  • University Hospital Centre of Saint-Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • University Hospital of Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • University Hospital Centre of Toulouse

    Toulouse,
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.