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

January 22, 2020 updated by: University Hospital, Caen

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14033
        • Recruiting
        • University hospital center of Caen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric BERGER, Pr
        • Principal Investigator:
          • Claudine LEBRUN-FRENAY, Pr
        • Principal Investigator:
          • David BRASSAT, Pr
        • Principal Investigator:
          • David LAPLAUD, Pr
        • Principal Investigator:
          • Jérôme DE SEZE, Pr
        • Principal Investigator:
          • Bruno BROCHET, Pr
        • Principal Investigator:
          • Gilles DEFER, Pr
        • Principal Investigator:
          • Gilles EDAN, Pr
        • Principal Investigator:
          • Giovanni CASTELNOVO, Pr
        • Principal Investigator:
          • Jean PELLETIER, Pr
        • Principal Investigator:
          • Jean-Philippe CAMDESSANCHE, Pr
        • Principal Investigator:
          • Pierre CLAVELOU, Pr
        • Principal Investigator:
          • Pierre LABAUGE, Pr
        • Principal Investigator:
          • Sandra VUKUSIC, Pr
        • Principal Investigator:
          • Thilbault MOREAU, Pr
        • Principal Investigator:
          • Marc DEBOUVERIE, Pr
        • Principal Investigator:
          • Patrick VERMERSH, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include all patients registered in 17 selected French OFSEP centres with core dataset with a sufficient level of data (Besançon, Bordeaux, Caen, Clermont-Ferrand, Dijon, Lille, Lyon, Marseille, Nancy, Nice, Rennes, Saint-Etienne, Strasbourg, Toulouse, Montpellier, Nantes, Nîmes). The minimum required data includes: 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.

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excess mortality survival
Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Net survival is defined as the probability of death in a hypothetical setting where the cause of interest (in our case MS) would be the only possible cause of death. It is directly linked to the concept of the "excess mortality due to the studied disease". Net survival can be calculated according to two settings, either the estimator of survival can be calculated from death due to MS while cause of death are known, either it can be calculated from the excess of mortality due to MS compared to the mortality of the general population obtained from mortality table of the generable population.
From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Deprivation Index (EDI) proxy of Socio-Economic Status
Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.

The EDI Score is a combination of weighted ecological variates and is available for each 'IRIS area' (Ilots regroupés pour l'Information Statistique). An IRIS area represents the smallest geographical entity for which census data are available in France.

The geolocation of each individual address, according to latitude and longitude coordinates, is performed with the system of geographical information (SGI) ARGIS® 10.5. This point of geolocation is correlated to the IRIS area and then an EDI score can be attributed to patients registered in the database. The EDI score can be categorized into quintiles.
From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Distance to MS expert care center
Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Distance in kilometer by road transport from residence place to MS expert care center
From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Hospices Civils de Lyon
Ecole des Hautes Etudes en Santé Publique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2019

Primary Completion (ANTICIPATED)

April 30, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (ACTUAL)

July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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