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2024-11-20 -
EDMUS Foundation / OFSEP Call for research proposals
The EDMUS Foundation, in partnership with the France Sclérose en Plaques Foundation, launches its 10th call for research proposals. It aims at fostering research with relevance to multiple sclerosis and related disorders, provided the studies are using data collected / or to be collected by the Observatoire Français de la Sclérose en Plaques (OFSEP). More details on the EDMUS Foundation website.
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2023-11-27 -
EDMUS Foundation / OFSEP Call for research proposals
The EDMUS Foundation, in partnership with the ARSEP Foundation, launches its ninth call for research proposals. It aims at fostering research with relevance to multiple sclerosis and related disorders, provided the studies are using data collected / or to be collected by the Observatoire Français de la Sclérose en Plaques (OFSEP). More details on the EDMUS Foundation website.
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2023-10-04 -
39th ECTRIMS Congress
39th ECTRIMS Congress (European Committee for Treatment and Research in Multiple Sclerosis) will be held in Milan from 11 to 13 October 2023. Our coordination team will welcome you at stand E44.
EDMUS Centers
| Localisation | Début du recueil | Spécificité du recueil | |
| Alsace Champagne-Ardenne Lorraine | |||
| Nancy - CHU de Nancy, Hôpital Central | 1996 | Registre populationnel lorrain de la SEP3 | |
| Reims - CHU de Reims, Hôpital Maison Blanche | 2011 | CHU | |
| Strasbourg - CHU de Strasbourg, Hôpital Civil | 2005 | CHU et réseau hospitalier régional3 | |
| Aquitaine Limousin Poitou-Charentes | |||
| Bordeaux - CHU de Bordeaux, Hôpital Pellegrin | 1993 | CHU | |
| Limoges - CHU de Limoges, Hôpital Dupuytren | 2008 | CHU | |
| Poitiers - CHU de Poitiers | 2014 | CHU | |
| Auvergne Rhône-Alpes | |||
| Clermont-Ferrand - CHU de Clermont-Ferrand, Hôpital Gabriel Montpied | 2001 | CHU | |
| Grenoble - CHU de Grenoble, Hôpital de la Tronche | 2015 | CHU | |
| Lyon - Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer | 1976 | CHU | |
| Saint-Etienne - CHU de Saint-Etienne, Hôpital Nord | 2007 | CHU | |
| Bourgogne Franche-Comté | |||
| Dijon - CHU de Dijon, Hôpital Général | 2001 | CHU et réseau hospitalier régional partiel et réseau régional de soins1 | |
| Besançon - CHU de Besançon, Hôpital Jean Minjoz | 2001 | CHU | |
| Bretagne | |||
| Brest - CHRU de Brest, Hôpital de la Cavale Blanche | 2014 | CHU | |
| Rennes - CHU de Rennes, Hôpital Pontchaillou | 1990 | CHU et réseau régional de soins1,5 | |
| Centre-Val de Loire | |||
| Tours - CHU de Tours, Hôpital Bretonneau | 2008 | CHU | |
| Île-de-France | |||
| Créteil - APHP, Hôpital Henri Mondor | 2011 | CHU | |
| Corbeil-Essonnes - CH de Corbeil-Essonnes | 2015 | CH | |
| Paris - Assistance Publique des Hôpitaux de Paris (APHP), Hôpital Bicêtre – Enfants | 2004 | CHU (données transmises une fois les patients majeurs) | |
| Paris - APHP, Hôpital Bicêtre – Adultes | 2012 | CHU | |
| Paris - APHP, Hôpital de la Salpêtrière | 2000 | CHU | |
| Paris - APHP, Hôpital Saint-Antoine | 2010 | CHU | |
| Paris - Fondation Rothschild | 2013 | Fondation et correspondants neurologues libéraux | |
| Poissy Saint-Germain - CH de Poissy | 2005 | CH | |
| Pontoise - CH de Pontoise | 2015 | CH | |
| Saint-Denis - CH de Saint-Denis, Hôpital Delafontaine | 2010 | CHG | |
| Versailles - CH de Versailles, Hôpital André-Mignot | 2015 | CHG | |
| Languedoc-Roussillon Midi-Pyrénées | |||
| Montpellier - CHU de Montpellier, Hôpital Gui de Chauliac | 2007 | CHU | |
| Nîmes - CHU de Nîmes, Hôpital Caremeau | 2001 | CHU et réseau régional de soins1 | |
| Toulouse - CHU de Toulouse, Hôpital Purpan | 1993 | CHU | |
| Martinique | |||
| Fort-de-France - CHU La Meynard | 2003 | CHU et réseau régional de soins2 | |
| Nord-Pas-de-Calais Picardie | |||
| Amiens - CHU d’Amiens Hôpital Nord | 2012 | CHU | |
| Lille - CHU de Lille, Hôpital Roger Salengro | 2004 | CHU et réseau régional de soins1 | |
| Normandie | |||
| Caen - CHU de Caen, Hôpital Côte de Nacre | 2004 | CHU et réseau régional de soins1 | |
| Rouen - CHU de Rouen, Hôpital Charles-Nicolle | 2011 | CHU | |
| Pays-de-la-Loire | |||
| Nantes - CHU de Nantes, Hôpital Nord-Laennec | 2005 | CHU | |
| Provence-Alpes-Côte d'Azur | |||
| Marseille - Assistance Publique des Hôpitaux de Marseille, Hôpital de la Timone | 2004 | CHU | |
| Nice - CHU de Nice, Hôpital Pasteur | 1996 | CHU et réseau hospitalier régional4 | |
1 Réseau régional de soins ville-hôpital
2 En Martinique, le réseau inclut l’ensemble des neurologues libéraux et hospitalier
3 Registre recensant tous les cas (incidents et prévalents) de SEP des personnes résidant en région Lorraine. Le recueil s’appuie sur l’ensemble des neurologues de la région (hospitaliers, réseau de soins régionaux ville-hôpital, libéraux)
4 Inclut les Centre Hospitaliers généraux (CHG) de la région
5 En Bretagne, le réseau régional de soins ville-hôpital inclut tous les neurologues libéraux, les rééducateurs, quelques centaines de paramédicaux libéraux et 22 établissements hospitaliers de Bretagne
Biological Resource Centers (BRC)
| Localisation | Neurologue responsable | |
| Alsace Champagne-Ardenne Lorraine | ||
| Nancy - CRB Lorrain | Marc DEBOUVERIE | |
| Strasbourg - CRB du CHU de Strasbourg | Jérôme DE SÈZE | |
| Aquitaine Limousin Poitou-Charentes | ||
| Bordeaux - CRB plurithématique du CHU de Bordeaux | Bruno BROCHET | |
| Auvergne Rhône-Alpes | ||
| Clermont-Ferrand | ||
| Grenoble | ||
| Lyon - CRB HCL NeuroBioTec | Romain MARIGNIER | |
| Bourgogne Franche-Comté | ||
| Besançon | ||
| Dijon - CRB Ferdinand Cabanne du CHU de Dijon | Thibault MOREAU | |
| Bretagne | ||
| Rennes - CRB Santé du CHU de Rennes | Gilles EDAN | |
| Centre-Val de Loire | ||
| Tours - CRB de Touraine | Anne-Marie GUENNOC | |
| Île-de-France | ||
| Créteil - PRB Henri Mondor | Alain CREANGE | |
| Paris - REFGENSEP | Bertrand FONTAINE [Hôpital de la Salpêtrière] Bruno STANKOFF [Hôpital Saint-Antoine] |
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| Languedoc-Roussillon Midi-Pyrénées | ||
| Montpellier - CRB du CHRU de Montpellier | Pierre LABAUGE | |
| Nîmes - CRB du CHU de Nîmes | Eric THOUVENOT | |
| Toulouse | ||
| Nord-Pas-de-Calais Picardie | ||
| Amiens - Biobanque de Picardie | Abdullatif AL KHEDR | |
| Lille - CRB du CHRU de Lille | Helene ZEPHIR | |
| Normandie | ||
| Caen | ||
| Pays-de-la-Loire | ||
| Nantes - CRB du CHU de Nantes | David LAPLAUD | |
| Provence-Alpes-Côte d'Azur | ||
| Marseille - CRB de l'AP-HM | Jean PELLETIER | |
| Nice | Christine LEBRUN-FRENAY | |
Imaging Resource Centers (IRC)
EDMUS Centers, BRC & IRC
The Scientific Coordinator is responsible for the general coordination of OFSEP. He or she is in charge of collaborative relations with health care authorities, learned societies, the French National Research Agency (ANR) and industrials partners, representing the Project in face of third parties. The Scientific Coordinator might request the assistance of a member(s) of the Steering Committee or the National Coordination Center for this mission.
The Assistant Scientific Coordinator is appointed by the Steering Committee to co-chair the Strategic Scientific Board. He or she provides a complementary expertise to the Scientific Coordinator to define, implement and monitor the scientific objectives of the OFSEP Project.
The Executive Office of the Steering Committee prepares the files to be discussed during committee meetings, initiating discussions on the strategic orientations of OFSEP.
Missions:
- Expertise and work on files with a strategic orientation for the project
- Follow-up of questions raised in Steering Committee meetings requiring more detailed investigation
- Discussion of ethical, legal and technical matters, as necessary
- Elaboration and advanced proof-reading of reference documents
- Miscellaneous proposals and recommendations
The Steering Committee has both decision-making and operational responsibilities: it defines the strategic orientations of OFSEP and appoints the people charged with monitoring their implementation.
The Steering Committee meets once a month. It may request the opinions of internal experts (particularly the members of the National Coordination Center) or external experts before coming to a decision.
Missions:
- Routine project management
- Communication and publication of the decisions made and chosen orientations
- Appointment of work group managers
- Appointment of co-chairmen of the Scientific Board
- Coordination with OFSEP's EDMUS centers, BRCs (biological resource centers) and imaging centers
- Distribution of financial resources
- Analysis of recommendations from the Scientific Board and the work groups
- Relations with the health insurance fund, health care authorities and industrial players
The mission of the Strategic Scientific Board is to define the OFSEP scientific strategy as well as operational scientific objectives pertaining to this strategy (definition of inclusion criteria, data to collect, statistical analysis to carry out) in order to respond to major scientific orientations.
The Committee is composed of a maximum of twelve scientists (methodologists, epidemiologists, statisticians, etc.) and neurologists upon the proposal of the Steering Committee validated by the Scientific Coordinator and the Assistant Scientific Coordinator. It is co-chaired by the Scientific Coordinator and the Assistant Scientific Coordinator.
The Scientific Board is a consultative body.
It offers an opinion on the orientation proposals from the work groups (particularly on the type of minimal data and the minimal biological samples) as well as on the research projects and data access requests submitted to OFSEP.
The National Coordination Center (NCC) is responsible for the operational organization of the project. As such, National Coordination Center members participate in Steering Committee sessions to provide operational and technical opinions.
Main missions:
- Cohort operation
- Daily assistance for the centers in the collection of data (definition of collection and entry instructions, support, training, information, audits, etc.)
- Organization of the anonymization, centralization and management processes for the databases.
- Evaluation of OFSEP data quality, in collaboration with the work groups and the Scientific Board. Definition and publication of tools to improve data quality.
For these missions, the NCC has a project manager for each collection area (clinical, biology, imaging), who reports to the OFSEP Data and Tools Manager.
- Management of research projects (internal and external, academic and industrial)
- Evaluation of the feasibility and methodology of new research projects submitted to OFSEP.
- Assistance with project preparation: the Coordination Center can offer expert advice on the availability of data, data circuit and collection, statistical analysis plan, budgets, contracts, etc.
- Analysis of data and drafting of reports.
- Provision of raw data (in certain specific situations).
For these missions, the NCC has partnership managers (academic and industrial) who are main contact for project leaders. For each project, they are assisted by skilled team members (project managers, epidemiologists, statisticians, etc.).
- General coordination of OFSEP infrastructures
- Relationship management with participating centers in data collection
- Contracts and agreements management for industrial and academic collaborations
- Implementation and follow-up of quality procedures
- Development of human and financial resources of the project
- Communication and public relations
For these missions, the NCC has a Contract Manager, Coordination Technician and a Quality Advisor who report to the Resources Manager.
Pr Sandra VUKUSIC
OFSEP Scientific Coordinator
Lucie BELLON-TABART
Resources Manager
Amalle ABDELALI
Collaborations Assistant
Guillaume BROCARD
Biology Project Manager
Romain CASEY
Cohort Manager
Jean-Christophe CHABERT
Financial Director
Carine CHEVAL
Computer Scientist
Floriane DAZEUR
Clinical Research Technician
Anne-Cécile DE GIACOMONI
Contract Manager
Nadine DEBARD
Clinical Project Manager
Illiasse EL BAHI
Biostatistician
Baptiste GEORGES
Computer Scientist
Céline HOMO
Imaging Project Manager
Taïssia LELEKOV-BOISSARD
Clinical Research Associate
Véronique MILLOT
Coordination Technician
Fama NDIAYE
Computer Scientist
Selva ODEESH
Data Manager
Ludivine ORER
Quality & Risk Management Policy Officer
Fabien ROLLOT
Biostatistician Manager
Félix SANDJO
Data Manager
Kpoti-Kpobada TETEGAN
Data Manager
Irena VUKUSIC
Collaborations Manager
Work groups
Three operational and scientific work groups provide expert advice on the collection of data and the operational aspects of what can be done with these data. These are the clinical, biology and imaging groups, each corresponding to the types of data collected.
The clinical group is coordinated by Prof. Jérôme DE SEZE (Strasbourg). The operational project manager of this group is Nadine DEBARD (Lyon).
Objectives:
- To define basic clinical data for all MS patients in the overall OFSEP cohort
- To define strategies to prioritize certain projects of interest
- To define strategies to implement monitoring of the quality of the data collected ("quality" sub-group)
IT tool: EDMUS software.
Minimal collection:
- To collect the data from the OFSEP form for each patient consultation or hospitalization, to ensure exhaustive, quality collection of the minimal data
- Collection of the following data: socio-demographic data, neurological episodes, clinical evaluations, irreversible disability, MRI and basic treatments
The biology group is coordinated by Prof. David LAPLAUD (Nantes). The operational project manager of this group is Guillaume BROCARD (Lyon).
Objectives:
- To define the basic biological samples of MS patients in the OFSEP cohort
- To define strategies to prioritize certain specific sub-populations
- To coordinate the actions of the participating BRCs (biological resource centers)
IT tool: Centralized base TK®.
Minimal collection:
- Mandatory biological samples (blood and urine) and optional biological samples (CSF, stools).
- Samples for the specific patient sub-groups (radiologically isolated syndrome, clinically isolated syndrome, Devic's syndrome, PPMS, PML and ADEM)
- Collection only in centers with an OFSEP BRC
The imaging group is coordinated by Prof. François COTTON (Lyon) and Prof. Vincent DOUSSET (Bordeaux). The operational project manager of this group is Céline HOMO (Lyon).
Objectives:
- Main objective: to integrate the MRI scans of all patients in the parent cohort (patients with minimal clinical data) and to collect more detailed MRI data for the nested cohorts
- To establish a common OFSEP imaging protocol (minimal sequences)
- To acquire, process and integrate the imaging data and their derivatives on a centralized imaging platform (Shanoir) to ensure interoperability with the EDMUS clinical database
- To run systematic quality checks on centralized MRI data
IT tool: Shanoir web platform and ShanoirUploader software.
Minimal collection:
- Minimal sequences installed directly on the machines by the leading MRI machine manufacturers, additional sequences proposed.
- At least one cerebral MRI every three years and one medulla MRI every six years, in the minimal format.
Alongside the work groups, two other transversal groups provide support services: legal group and communication group.
The legal group meets whenever a specific need is identified. It defines and drafts the legal documents for OFSEP (consent forms, charters, agreements, etc.).
The communication group was created in order to propose communication initiatives and to implement them in collaboration with the National Coordination Center.
The annual OFSEP convention brings together the various parties involved in OFSEP to review the previous year and decide upon the actions to be taken for the year to come. It offers an opportunity for work groups to get together physically for long periods, before reporting their progress proposals to all participants during the plenary session and enable their discussion. It also enables training of the clinical research associates (CRAs) working in the participating centers.
Attendance is by invitation from OFSEP. Registration is mandatory.
The dates of the next conventions are:
- Thursday 20 - Friday 21 March 2025, LYON
The international Advisory Committee (IAC) provides an external point of view and offers scientific, ethical and strategic opinions on the actions and orientations of OFSEP.
It meets upon request from the Steering Committee when specific issues arise requiring its opinion, once a year, on average.
The Consortium Committee is composed of a representative of EDMUS Foundation, a representative of Lyon University Hospital and a representative of Claude Bernard Lyon 1 University. It is in charge of coordinating the perpetuation of the OFSEP, under the control of the Eugène Devic Edmus Foundation and to ensure the budget distribution.
It meets upon request from the Scientific Coordinator as needed.
To find out more about progression of the disease
Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system, causing the immune system to destroy the sheath of the nerve fibers (myelin) of the brain, spinal cord and the optical nerves.
MS can be characterized by two different events:
- Relapse (or attack): the appearance, generally over a few hours or days, of neurological symptoms (difficulties with walking and balance, tingling and numbness, vision problems, etc.) lasting between a few days and a few weeks (but always longer than 24 hours), then suddenly disappearing, either completely or leaving certain after-effects.
- Progression: the slow, insidious appearance of neurological disorders similar to those described for the relapses but over a period of at least six months, with no regression.
Depending on the occurrence of these two events during a patient's life, disease courses are defined:
- Clinically isolated syndrome (CIS): patients who have had just one attack;
- Relapsing-remitting MS: the patients suffer relapses with partial or full recovery, and symptoms are stable between two relapses;
- Secondary progressive MS: after a phase of relapsing-remitting MS, symptoms start to get progressively worse;
- Primary progressive MS: the symptoms gradually worsen from the start.
MS epidemiology
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MS starts at the age of 30 on average, i.e. a time in life when people are in the middle of building their personal, family, professional and social lives. The cause of the disease is not yet known and it is likely that a combination of several factors leads to onset of the disease, including genetic, environmental and infectious factors. |
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Women are three times more affected than men.|
In France, MS strikes 1 in 650 people, i.e. between 80,000 and 120,000 people, with 5,000 new cases being diagnosed each year. |
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MS has little impact on life expectancy. However, historically, it could cause serious disability, heavily altering the lives of those affected. On average, it caused definitive walking difficulties after 10 years, the need for a cane after 20 years and the use of wheelchair after 30 years. The recent developments of high-effective therapies allow to reduce the frequency of relapses and significantly delay the disability onset. A much better long-term prognosis can be anticipated amongst recently diagnosed and early-treated patients. However, no treatment has yet been found to cure MS or improve its effects.
The EDMUS computerized medical file
The EDMUS (European Database for MUltiple Sclerosis) software is a computerized medical file to enable the clinician to record and use the clinical data of his MS patients for medical purposes. It is designed to facilitate the routine work of the neurologist, who can enter only essential data or full details of his patients' medical follow-up, as he wishes. Each center in the OFSEP project has an EDMUS database.
The EDMUS software belongs to the Eugène Devic EDMUS foundation.
Find out more about the clinical work group
Find out more about the collection of clinical data (Professionals)
The Shanoir platform for collecting MRI (magnetic resonance imaging) data
The platform Shanoir (Sharing NeurOImaging Resources) is an open source software solution offering secure web access to structure, manage, archive and share neuroimaging data. The ShanoirUploader application enables communication, within a hospital, with the Picture Archiving and Communication System (PACS) to facilitate the transfer of anonymized MRI examinations to the Shanoir platform.
Shanoir was developed by the VisAGeS research team (manager: Christian Barillot), belonging to IRISA (IT and random systems research institute), affiliated to Inria Rennes – Bretagne Atlantique and INSERM.
Find out more about the imaging work group
Find out more about the collection of imaging data (Professionals)
The virtual biological resource center, TumoroteK (TK), to collect and manage biological samples
The TK® open source, biological sample management software is used by many French BRCs (biological resource centers).
The biological samples (serum, plasma, urine, etc.) in the OFSEP biological collection are kept in one of the OFSEP participant centers, but the anonymized data concerning these samples are compiled in a single TumoroteK database, thus representing a virtual BRC.
TK® is developed by Saint-Louis hospital in Paris.
Find out more about the biology work group
Find out more about the collection of biological data (Professionals)
OFSEP's common database
Twice a year, data respecting patient confidentiality rules are exported from the EDMUS databases to the OFSEP National Coordination Center. Similarly, data from the Shanoir platform and from the TumoroteK database are also exported to the OFSEP coordination center.
The compilation of all these data represents the OFSEP common database. This database offers the following possibilities:
- Evaluation of the feasibility of research projects by identifying patient groups according to specific characteristics
- Internal data extraction and statistical analysis for OFSEP or external project holders in order to answer research questions
- In some particular cases, data extraction to be provided to research teams
Extraction and analysis of data are possible only after approval by the Scientific Board and Steering Committee.
The future national platform
A secure national platform will, in the future, enable real time association of the clinical data collected via EDMUS, the MRIs stored in Shanoir and monitoring data of the centralized sample stocks in TK®. This platform aims to facilitate clinical research (better management of double entries, easier multi-criteria searches, etc.) and to improve the routine follow-up of patients by offering neurologists easy access to their patients' information no matter where or when the data were collected. This platform is currently in the design stage.
