C10.114.375.500ECOVIMUSNCT04028232
Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).
An observational study of C10.114.375.500, run by University Hospital, Caen at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- C10.114.375.500
- How many people
- 30,000 participants
- Where
- 18 sitesFrance
- Study dates
- 10 Jul 2019to 31 Dec 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- MS patients with less than one year's disease duration by the study end will be excluded.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites, 18 recruiting
- Recruiting
University Hospital of Besancon
Besançon
Eric BERGER, Professor, eberger@chu-besancon.fr
- Recruiting
University Hospital of Bordeaux
Bordeaux
Bruno BROCHET, Professor, bruno.brochet@chu-bordeaux.fr
- Recruiting
University Hospital Center of CAEN
Caen, Normandy, 14033
Gilles-Louis DEFER, Professor, 0033231064617, defer-gi@chu-caen.fr
Floriane CALOCER, PharmD/PhD, 0033231064617, calocer-fl@chu-caen.fr
- Recruiting
University Hospital Centre of Caen
Caen
Gilles-Louis DEFER, Professor, 0033231064617, defer-gi@chu-caen.fr
Floriane CALOCER, PharmD/PhD Student, 0033231064617, calocer-fl@chu-caen.fr
- Recruiting
University Hospital of Clermont Ferrand
Clermont-Ferrand
Pierre CLAVELOU, Professor, pclavelou@chu-clermontferrand.fr
- Recruiting
University Hospital of Dijon
Dijon
Thibault MOREAU, Professor, thibault.moreau@chu-dijon.fr
- Recruiting
University Hospital of Lille
Lille
Patrick VERMERSCH, Professor, patrick.vermersch@univ-lille2.fr
- Recruiting
University Hospital of Lyon
Lyon
Sandra VUKUSIC, sandra.vukusic@chu-lyon.fr
- Recruiting
University Hospital of Marseille
Marseille
Jean PELLETIER, Professor, jean.pelletier@ap-hm.fr
- Recruiting
University Hospital of Montpellier
Montpellier
LABAUGE Pierre, Professor, p-labauge@chu-montpellier.fr
- Recruiting
University Hospital of Nancy
Nancy
Marc DEBOUVERIE, Professor, m.debouverie@chu-nancy.fr
- Recruiting
University Hospital of Nantes
Nantes
David LAPLAUD, Professor, david.laplaud@univ-nantes.fr
- Recruiting
University Hospital of Nice
Nice
Christine LEBRUN-FRENAY, Professor, lebrun-frenay.c@chu-nice.fr
- Recruiting
University hospital Centre of Nîmes
Nîmes
Giovanni CASTELNOVO, Professor, giovanni.castelnovo@chu-nimes.fr
- Recruiting
University Hospital of Rennes
Rennes
Gilles EDAN, Professor, gilles.edan@chu-rennes.fr
- Recruiting
University Hospital Centre of Saint-Etienne
Saint-Etienne
Jean-phillipe CAMDESSANCHE, Professor, j.philippe.camdessanche@chu-st-etienne.fr
- Recruiting
University Hospital of Strasbourg
Strasbourg
Jérôme DE SEZE, Professor, jerome.de.seze@chru-strasbourg.fr
- Recruiting
University Hospital Centre of Toulouse
Toulouse
David BRASSAT, Professor, brassat.d@chu-toulouse.fr
About this study
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).
Read more
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.
- Conditions
- C10.114.375.500
- Keywords
- Multiple Sclerosis, Epidemiology, Socio-Economic Status, Net Survival
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess mortality survival
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.
Measured: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Secondary outcomes (2)
European Deprivation Index (EDI) proxy of Socio-Economic Status
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.
Measured: 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
Distance in kilometer by road transport from residence place to MS expert care center
Measured: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start10 Jul 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C10.114.375.500Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique, Hospices Civils de Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028232
- Sponsor's protocol ID
- 18512
- Acronym
- ECOVIMUS
- Status last verified
- Jan 2020
- First submitted
- 19 Jul 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).
- ClinicalTrials.gov ID
- NCT04028232
- Acronym / sponsor ID
- ECOVIMUS / 18512
- Conditions
- C10.114.375.500
- Keywords
- Multiple Sclerosis, Epidemiology, Socio-Economic Status, Net Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique, Hospices Civils de Lyon
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- MS patients with less than one year's disease duration by the study end will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C10.114.375.500, run by University Hospital, Caen at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles-Louis DEFER, Professor (0033231064617, defer-gi@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.