{"doc_desc":{"title":"Cohorte Fran\u00e7aise de 3 maladies mentales majeures: Troubles bipolaires, Schizophr\u00e9nie, et Asperger","idno":"FRESH-PEF3145-fr","producers":[{"name":"Marion LEBOYER","affiliation":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3145-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3145"},{"agency":"FReSH","code":"FRESH-PEF3145"}]},"title":"Cohorte Fran\u00e7aise de 3 maladies mentales majeures: Troubles bipolaires, Schizophr\u00e9nie, et Asperger","alternate_title":"Psy-COH"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Marion;LEBOYER","PILabo":"Fondation FondaMental - UPEC - Inserm","affiliationName":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","extlink":[{"title":"ORCID","uri":"0000-0001-5473-3697","role":"pi id"},{"title":"IdRef","uri":"089352475","role":"pi id"},{"title":"SIREN","uri":"199411117","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"marion.leboyer@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE SORBONNE PARIS NORD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0199hds37","role":"sponsor id"},{"title":"SIREN","uri":"199312380","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05ggc9x40","role":"sponsor id"},{"title":"SIREN","uri":"199411117","role":"sponsor id"}],"role":"sponsor"},{"name":"FONDATION FONDAMENTAL","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rrhf939","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]}]},"distribution_statement":{"contact":[{"name":"Marion;LEBOYER","email":"marion.leboyer@inserm.fr","type":"contact","affiliationName":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05ggc9x40","role":"organisation id","title":"ROR"},{"uri":"199411117","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Addictologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"Schizophr\u00e9nie","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","title":"CIM-11"}]},{"topic":"Troubles bipolaires ou apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/613065957","title":"CIM-11"}]},{"topic":"Troubles du spectre de l'autisme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/437815624","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"Le projet PSY-COH a pour objectifs principaux : 1. L'identification des formes cliniques (\u00e2ge de d\u00e9but, d\u00e9clin cognitif, comorbidit\u00e9s somatiques,..) des maladies et validation des diff\u00e9rentes \u00e9tapes d'\u00e9volution de la pathologie (staging). 2. La caract\u00e9risation des trajectoires des patients et de leurs \u00e9volutions dans les diff\u00e9rents stades de la maladie et au travers des indicateurs de comportements, biomarqueurs pr\u00e9dictifs et pronostics. 3. L'estimation de l'utilisation de services et soins de sant\u00e9, du co\u00fbt soci\u00e9tal, ainsi que de la qualit\u00e9 de vie des patients atteints de ces maladies. 4. L'am\u00e9lioration du diagnostic pr\u00e9coce et de la pr\u00e9vention des troubles mentaux \u00e9tudi\u00e9s en identifiant des biomarqueurs et biosignatures valides (construction de bio-banques permettant la mise en place des projets de recherche ancillaires). 5. Permettre aux collaborateurs acad\u00e9miques nationaux ou internationaux ou aux partenaires industriels d'acc\u00e9der \u00e0 la cohorte ou aux donn\u00e9es collect\u00e9es, et permettre d'acc\u00e9l\u00e9rer le progr\u00e8s scientifique dans l'\u00e9tude de ces pathologies. La phase de pr\u00e9paration de ce projet a d\u00e9but\u00e9 en 2011, et il est pr\u00e9vu que l'inclusion des patients d\u00e9butera en 2012. Les premiers r\u00e9sultats de l'\u00e9tude sont planifi\u00e9s pour 2015. La premi\u00e8re \u00e9tape du projet se focalisera sur la cohorte des troubles bipolaires.","abstract":"","coll_dates":[{"start":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients pr\u00e9sentant des troubles psychotiques (troubles bipolaires, et schizophr\u00e9nie) ou pr\u00e9sentant des troubles du d\u00e9veloppement (autisme sans retard mental, ou syndr\u00f4me d'Aspeger)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Tests psychologiques\/\u00e9chelles cliniques (d\u00e9pression, cognition, qualit\u00e9 de vie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"We aim to recruit 1000 bipolar, 800 schizophrenic, and 200 Asperger patients."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"L'acc\u00e8s aux donn\u00e9es de la cohorte Psy-COH sera possible pour des collaborateurs acad\u00e9miques et pour des partenaires industriels, de fa\u00e7on directe ou indirecte, pour donner naissance \u00e0 de nombreuses initiatives de projets.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"01-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"10-02-2014","isContributorPI":"Non","contributorName":"Marion LEBOYER","contributorAffiliation":"UNIVERSITE PARIS EST CRETEIL VAL DE MARNE (UPEC)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.fondation-fondamental.org\/"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":["","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Un dossier m\u00e9dical informatis\u00e9 a \u00e9t\u00e9 cr\u00e9\u00e9 et mis en place dans les Centres Experts. Il permet d'enregistrer et de partager entre les centres les donn\u00e9es cliniques. Trois variants de dossiers m\u00e9dicaux informatis\u00e9s existent (e-FondaMental) pour favoriser une psychiatrie \"extensive\" (?), pour valider des mesures cognitives et somatiques r\u00e9alis\u00e9es par des psychiatres, psychologues, et infirmi\u00e8res entrain\u00e9es. Ces trois variants de dossiers m\u00e9dicaux informatis\u00e9s (e-bipolaire, e-schizo, e-asperger) ont d\u00e9j\u00e0 \u00e9t\u00e9 construits pour favoriser l'appr\u00e9ciation et le suivi de chacun de ces troubles, et pour permettre l'impl\u00e9mentation d'une approche personnalis\u00e9e des soins et du traitement de chaque patient, partag\u00e9e avec les cliniciens r\u00e9f\u00e9rents (m\u00e9decin g\u00e9n\u00e9raliste, psychiatre). Un base de donn\u00e9es nationale, pathologie sp\u00e9cifique, concentre les donn\u00e9es cliniques anonymis\u00e9es issues de tous les Centres Experts et permet le suivi de cohorte. En plus de cette approche clinique, le r\u00e9seau d\u00e9veloppe un lien entre cette base de donn\u00e9es de grande \u00e9chelle et les biobanques ainsi que les plateformes de g\u00e9notypage et d'imagerie c\u00e9r\u00e9brale.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Les patients seront recrut\u00e9s dans les Centres Experts au niveau national. Ce r\u00e9seau est compos\u00e9 de 8 Centres Experts sur les troubles bipolaires (Bordeaux, Cr\u00e9teil, Grenoble, Marseille, Montpellier, Paris, Strasbourg, Versailles), de 10 Centres Experts pour la schizophr\u00e9nie (Bordeaux, Clermont-Ferrand, Colombes, Cr\u00e9teil, Grenoble, Lyon, Marseille, Montpellier, Strasbourg, Versailles), et de 4 Centres Experts pour le syndr\u00f4me d'Asperger (Bordeaux, Cr\u00e9teil, Grenoble, Paris)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"NFS, gaz du sang, \u00e9lectrolytes, glyc\u00e9mie, bilan lipidique, bilan h\u00e9patique, bilan thyro\u00efdien, albumine, prot\u00e9ines totales, ur\u00e9e, acide urique, cr\u00e9atinine, phosphore, fer, calc\u00e9mie, dosages psychotropes, ...","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}