OFSEP – Observatoire Français de la Sclérose en Plaques

L'OFSEP fait partie des 10 cohortes sélectionnées en réponse à l'appel à projets "Cohortes 2010" du programme "Investissements d'Avenir". Il bénéficie ainsi d'un soutien de l'Agence Nationale pour la Recherche (ANR) d'environ 10 millions d'euros pour les 10 ans à venir.

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L'OFSEP a été fondé par le Professeur Christian CONFAVREUX et est coordonné à Lyon par le Service de Neurologie A à l'Hôpital Neurologique Pierre Wertheimer (Pr Sandra VUKUSIC). Il est porté par un consortium associant la Fondation Eugène Devic EDMUS contre la sclérose en plaques (Fondation EDMUS), l'Université Claude Bernard Lyon 1 (UCBL1) et les Hospices Civils de Lyon (HCL).
Il repose sur un réseau de neurologues répartis sur l’ensemble du territoire français et rattachés à 61 centres utilisateurs d'EDMUS (European Database for MUltiple Sclerosis). La cohorte OFSEP est nationale et ouverte. Elle comporte plus de 35.000 personnes atteintes de SEP, soit environ la moitié des malades résidant en France. Par la généralisation du suivi longitudinal et l'association systématique des données cliniques à des prélèvements biologiques et à la neuro-imagerie, le projet OFSEP a pour double objectif d'améliorer la qualité, l'efficacité et la sécurité des soins et de favoriser les recherches cliniques, fondamentales et translationnelles dans la SEP.

 

Fiche technique du Projet

Programme : "Cohortes 2010" dans le cadre du programme "Investissements d'Avenir"
Coordinateur: Université Claude Bernard Lyon 1, Prof. Sandra VUKUSIC
Partenaires :
o 31 Hôpitaux et Centres Experts français
o 16 Réseaux de Santé Ville-Hôpital
o Fondation Eugène Devic EDMUS
o Hospices Civils de Lyon
o Lyon Ingénierie Projets (FR)

• Coût Total: € 9.479.142
• Durée : 2011-2019 • Site web : www.ofsep.org

Context

Multiple Sclerosis (MS) is a chronic disease of the central nervous system. It is the most common cause of neurological disability in young adults, around 1 person in 1000 being affected in Western countries. It begins on the average by age 30, i.e. at a crucial moment in the personal, family, professional and social structuring of the individual. It leads to permanent disability for decades with marginal effect on life expectancy. The burden of MS is huge for the society, circa 8.9 M€ per year in the EU. It is rapidly increasing with the approval and diffusion of new Disease Modifying Treatments (DMTs).

Objectives

The general objectives of the present application are threefold:
1- to maintain and expand the nationwide cohort of PwMS, providing a “photograph” of MS in France which might lead to a unique source of information on the epidemiology of the disease, on its personal, familial, professional, and social consequences, and on the effect of DMTs;
2- to maintain and develop existing nested cohorts and to implement new ones, addressing specific issues such as the pharmaco-epidemiology of recently introduced DMTs and their cost-effectiveness;
3- to enrich currently available clinical data with biological samples, imaging material and medico-socio-economic data.

Concretely, the operational objectives are to:
1- Maintain and develop the nationwide French cohort of PwMS by: agreeing on the minimum amount of standardized data for the clinical, medico-socio-economic, biological, imaging, and therapeutic assessments of each patient included in the cohort; agreeing on the biological, genetic included, and imaging material to be stored for each patient; promoting systematic multimodal assessments and prospective longitudinal follow-up; implementing quality control procedures for each type of material.
2- Maintain and/or develop the centralizing facilities: the EDMUS software and Coordinating Center; a nationwide network of BRCs dedicated to MS; a nationwide network of Imaging Resource Centres (IRCs) dedicated to MS.
3- Maintain and develop existing studies: - assessing the efficacy of DMTs on the accumulation of disability in the long-term; - assessing the incidence/prevalence of cancers in PwMS relatively to the French general population and its possible variation with DMTs use; - updating the ‘historical’ Lyon natural history MS cohort to allow a final assessment of the prognosis of the disease in the very long term; - developing the childhood MS onset cohort for assessing its specific traits and effect of DMTs in this population; - developing the Devic’s neuromyelitis optica cohort for assessing disease course, prognostic factors, biological markers, pathophysiological pathways and therapeutic issues which could be paradigmatic for MS.
4- Implement new nested cohorts: - surveillance of safety and efficacy of new DMTs to come in the near future, within the frame of RMPs to be implemented by AFSSAPS; - setting up of a cohort of patients enrolled prospectively from their first episode (clinically isolated syndromes, CIS) and followed longitudinally with systematic multimodal assessments, to develop suitable and reliable predictive tools of the individual prognosis.
5- Set up a link between each OFSEP patient file and the Caisse Nationale d’Assurance Maladie des Travailleurs Salariés (CNAMTS), the Régime Social des Indépendants (RSI) or the Mutualité Sociale Agricole (MSA) file for following in parallel, longitudinally and prospectively, the evolution of the disease and of the medical costs related to the patient, and assessing the influence of the treatment status.
6- Develop a collaboration with the Haute Autorité de Santé (HAS), namely its ‘Commission de Transparence’ in the assessment of DMTs efficacy.
7- Open access to the data/samples of this cohort to research institutions, public or private, and to the pharmaceutical industry for promoting translational and basic research.
• A randomized preoperative radiotherapy trial in retroperitoneal sarcomas (N=1 trial)
• A randomized neoadjuvant cytotoxic chemotherapy trial in localized tumours (N=2 trial)
• 6 trials exploring targeted therapies in rare sarcoma subtypes in prospective randomized trials and in phase II proof of concept studies Biological and clinical material that will be collected in this trial will then be used to perform translational research on these tumours, and to characterize in depth their molecular alterations as well as the effects of drug interventions within the tumours.

Impact/Expected results

The OFSEP Project has a high potential and promises huge dividends. Making this large homogeneous cohort available and this organization implementable with a guarantee of strong, continuous and protracted human and material support for such a chronic disease as MS will offer PwMS, their relatives, physicians, researchers, pharmaceutical industry, public health services, and economists a nationwide and comprehensive “grand instrument épidémiologique” unique in the world. This will place France in an ideal position for translational research and development of innovative therapies in MS. This instrument is so relevant that it has drawn the attention of political decision-makers, national (AFSEP, APF, LFSEP, UNISEP) and international (EMSP) PwMS associations, and the international MS scientific society (ECTRIMS) who see in it a unique opportunity to improve the quality of life of persons suffering from this devastating and widespread disease.

Rôle de LIP

LIP a accompagné le porteur de projet dans toute la phase de montage : recherche de partenaires, définition des contours du projet, coordination du montage administratif et financier du projet, conseil à la rédaction, proposition d’un modèle de gouvernance, etc. LIP est également partenaire du projet, en charge de la direction opérationnelle et travaille activement à la pérennisation de l’observatoire.