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

NCT ID: NCT04028232

Last Updated: 2020-01-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-10

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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C10.114.375.500

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ecole des Hautes Etudes en Santé Publique

OTHER

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Center of CAEN

Caen, Normandy, France

Site Status RECRUITING

University Hospital of Besancon

Besançon, , France

Site Status RECRUITING

University Hospital of Bordeaux

Bordeaux, , France

Site Status RECRUITING

University Hospital Centre of Caen

Caen, , France

Site Status RECRUITING

University Hospital of Clermont Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

University Hospital of Dijon

Dijon, , France

Site Status RECRUITING

University Hospital of Lille

Lille, , France

Site Status RECRUITING

University Hospital of Lyon

Lyon, , France

Site Status RECRUITING

University Hospital of Marseille

Marseille, , France

Site Status RECRUITING

University Hospital of Montpellier

Montpellier, , France

Site Status RECRUITING

University Hospital of Nancy

Nancy, , France

Site Status RECRUITING

University Hospital of Nantes

Nantes, , France

Site Status RECRUITING

University Hospital of Nice

Nice, , France

Site Status RECRUITING

University hospital Centre of Nîmes

Nîmes, , France

Site Status RECRUITING

University Hospital of Rennes

Rennes, , France

Site Status RECRUITING

University Hospital Centre of Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

University Hospital of Strasbourg

Strasbourg, , France

Site Status RECRUITING

University Hospital Centre of Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles-Louis DEFER, Professor

Role: CONTACT

0033231064617

Floriane CALOCER, PharmD/PhD Student

Role: CONTACT

0033231064617

Facility Contacts

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Gilles-Louis DEFER, Professor

Role: primary

0033231064617

Floriane CALOCER, PharmD/PhD

Role: backup

0033231064617

Eric BERGER, Professor

Role: primary

Bruno BROCHET, Professor

Role: primary

Gilles-Louis DEFER, Professor

Role: primary

0033231064617

Floriane CALOCER, PharmD/PhD Student

Role: backup

0033231064617

Pierre CLAVELOU, Professor

Role: primary

Thibault MOREAU, Professor

Role: primary

Patrick VERMERSCH, Professor

Role: primary

Sandra VUKUSIC

Role: primary

Jean PELLETIER, Professor

Role: primary

LABAUGE Pierre, Professor

Role: primary

Marc DEBOUVERIE, Professor

Role: primary

David LAPLAUD, Professor

Role: primary

Christine LEBRUN-FRENAY, Professor

Role: primary

Giovanni CASTELNOVO, Professor

Role: primary

Gilles EDAN, Professor

Role: primary

Jean-phillipe CAMDESSANCHE, Professor

Role: primary

Jérôme DE SEZE, Professor

Role: primary

David BRASSAT, Professor

Role: primary

Other Identifiers

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18512

Identifier Type: -

Identifier Source: org_study_id

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