{"doc_desc":{"title":"Cohorte Prospective Multicentrique des Leuc\u00e9mies de l'Enfant et Adolescent","idno":"FRESH-PEF3269-fr","producers":[{"name":"Fran\u00e7oise VION-DURY","affiliation":"UNIVERSITE D'AIX MARSEILLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3269-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3269"},{"agency":"FReSH","code":"FRESH-PEF3269"}]},"title":"Cohorte Prospective Multicentrique des Leuc\u00e9mies de l'Enfant et Adolescent","alternate_title":"L.E.A."},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"ANSM"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Pascal;AUQUIER","PILabo":"Assistance Publique-H\u00f4pitaux de Marseille (APHM), Aix-Marseille \/ EA 3279 - Sant\u00e9 Publique et Maladies Chroniques : Qualit\u00e9 de vie, Concepts, Usages et limites, D\u00e9terminants.","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"","uri":"","role":"pi 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Chroniques : Qualit\u00e9 de vie, Concepts, Usages et limites, D\u00e9terminants.","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059817941","role":"pi id"},{"title":"SIREN","uri":"261300081","role":"organisation id"},{"title":"RNSR","uri":"200014577Z","role":"labo id"}],"email":"marie-claude.simeoni@univ-amu.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/002cp4060","role":"sponsor id"},{"title":"SIREN","uri":"261300081","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE REGIONALE D'HOSPITALISATION (ARH)","extlink":[{"title":"SIREN","uri":"182500199"}]},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE 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(LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]},{"name":"REGION PACA","extlink":[{"title":"SIREN","uri":"231300021"}]},{"name":"","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Pascal;AUQUIER","email":"pascal.auquier@univ-amu.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]},{"name":"G\u00e9rard;MICHEL","email":"gmichel@ap-hm.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]},{"name":"Marie-Claude;SIMEONI","email":"marie-claude.simeoni@univ-amu.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"leuc\u00e9mies"},{"keyword":"s\u00e9quelles tardives"},{"keyword":"effets ind\u00e9sirables m\u00e9dicamenteux \u00e0 long terme"},{"keyword":"enfants"},{"keyword":"adolescents"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Maladies du sang ou des organes h\u00e9matopo\u00ef\u00e9tiques","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1766440644","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectifs g\u00e9n\u00e9raux du projet: D\u00e9crire le devenir \u00e0 court et moyen terme d'une cohorte de patients trait\u00e9s pour leuc\u00e9mie aigu\u00eb au cours de leur enfance en terme de : - qualit\u00e9 de vie du patient et de son entourage - Insertion socio-\u00e9conomique - \u00e9tat de sant\u00e9 - relation au syst\u00e8me de soins \u00c9tudier les d\u00e9terminants (m\u00e9dicaux, socio\u00e9conomiques, comportementaux ou environnementaux) du devenir (\u00e9tat de sant\u00e9 et qualit\u00e9 de vie) \u00e0 moyen et long terme d'une cohorte de patients trait\u00e9s pour leuc\u00e9mie aig\u00fce au cours de leur enfance. \u00c9tudier les facteurs pr\u00e9dictifs de la survenue de s\u00e9quelles \u00e0 long terme sur la croissance saturo-pond\u00e9rale, la pubert\u00e9, la fertilit\u00e9, la fonction thyro\u00efdienne, la fonction visuelle, la fonction cardiaque, les contaminations virales, la fonction pulmonaire, le m\u00e9tabolisme osseux, le m\u00e9tabolisme du fer, le syndrome m\u00e9tabolique, les autres s\u00e9quelles. Explorer la mortalit\u00e9\/survie de cette cohorte de patients \u00e0 distance du traitement de la leuc\u00e9mie de l'enfance. Comparer les niveaux de qualit\u00e9 de vie de la cohorte de patients gu\u00e9ris de leuc\u00e9mie aig\u00fce \u00e0 ceux de sujets du m\u00eame sexe et \u00e2ge issus d'abaques, t\u00e9moins en bonne sant\u00e9 ou souffrant de pathologies chroniques. Perspectives du projet: Au regard de la litt\u00e9rature, la connaissance sur les d\u00e9terminants de l'\u00e9tat de sant\u00e9 et de la qualit\u00e9 de vie des patients apr\u00e8s traitement d'une leuc\u00e9mie aigu\u00eb de l'enfance reste aujourd'hui tr\u00e8s parcellaire pour proposer des strat\u00e9gies de prise en charge susceptibles d'am\u00e9liorer le devenir de ces enfants. Prenant en compte les limites de la Chilhood Cancer Survivor Study intrins\u00e8ques \u00e0 sa constitution, la cohorte LEA a montr\u00e9 sa faisabilit\u00e9 sur la p\u00e9riode 2004-2011. Cependant, il convient aujourd'hui d'\u00e9largir la base de repr\u00e9sentativit\u00e9 de cette cohorte tant en associant au projet les grands centres de prise en charge de la leuc\u00e9mie de l'enfant en France, qu'en instituant un consortium de recherche plus largement disciplinaire (HOPE-EPI). Les financements sollicit\u00e9s dans le cadre de l'ANR (Grand emprunt) visent \u00e0 poursuivre le travail r\u00e9alis\u00e9 et \u00e0 am\u00e9liorer le programme sur les principaux points suivants: augmentation du nombre de patients inclus, prise en compte d'un panel plus large de d\u00e9terminants, association \u00e0 de nouvelles \u00e9quipes cliniques de recherches. Un partenariat sera mis en place avec le registre national des h\u00e9mopathies malignes de l'enfant (dirig\u00e9 par J. Clavel) permettant d'optimiser l'exhaustivit\u00e9 de la file active. Par ailleurs, les grands protocoles multicentriques fran\u00e7ais actuels de traitement des leuc\u00e9mies aigu\u00ebs lymphoblastiques et my\u00e9loblastiques de l'enfant (EORTC, FRALLE, ELAM) sont repr\u00e9sent\u00e9s dans le projet par l'inclusion de nouveaux centres.","abstract":"","coll_dates":[{"start":"2004-01-01"}],"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\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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 atteints de leuc\u00e9mie aigu\u00eb lymphoblastique ou my\u00e9loblastique, \u00e2g\u00e9s de moins de 18 ans au moment du diagnostic, et qui ont \u00e9t\u00e9 diagnostiqu\u00e9s \u00e0 partir de janvier 1980. Les patients sont en r\u00e9mission h\u00e9matologique, et le traitement de la leuc\u00e9mie aig\u00fce a \u00e9t\u00e9 initi\u00e9 dans l'un des centres investigateurs. Autres crit\u00e8res: r\u00e9sidant en France, ayant donn\u00e9 son accord pour participer, ou une autorisation \u00e0 participer pour les mineurs\",\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\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":"plus de 5400 individus en 2020, avec environ 350 nouveaus individus par an et une moyenne de 1300 suivis r\u00e9alis\u00e9s chaque ann\u00e9e."},"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":"","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":"28-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":"Non","contributorName":"Fran\u00e7oise VION-DURY","contributorAffiliation":"UNIVERSITE D'AIX MARSEILLE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Publi-HAL-LEA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif","Industrie","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Industrie","Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)"],"otherFundingAgentType":["","","","","","","","","","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"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":"Pour les cas incidents, le recueil d'information est organis\u00e9 de fa\u00e7on prospective \u00e0 \u00e9ch\u00e9ance fixe \u00e0 partir de la date initiale de diagnostic. Pour les cas pr\u00e9valents, les donn\u00e9es recueillies sont similaires \u00e0 celles collect\u00e9es pour les cas incidents. Seul diff\u00e8re le mode de recueil qui est r\u00e9trospectif pour les \u00e9v\u00e8nements concernant la p\u00e9riode pr\u00e9c\u00e9dant la participation du centre au programme LEA (information concernant le diagnostic, traitements mis en place, survenue d'\u00e9v\u00e8nements de sant\u00e9 comprenant d\u00e9c\u00e8s, rechutes, s\u00e9quelles organiques des traitements) alors qu'il se fait de fa\u00e7on prospective pour les cas incidents.Les donn\u00e9es recueillies concernent d'une part les variables explicatives caract\u00e9risant l'\u00e9tat de sant\u00e9 et la qualit\u00e9 de vie des patients, d'autre parts des variables d\u00e9crivant les facteurs consid\u00e9r\u00e9s comme potentiels d\u00e9terminants. Parmi ces d\u00e9terminants potentiels, seront envisag\u00e9s des facteurs d\u00e9finis au niveau individuel (clinique, d\u00e9mographique...) mais aussi des facteurs populationnels (environnement...). Sont recueillies des donn\u00e9es:- socio-d\u00e9mographiques et socio-\u00e9conomiques relatives au patient et \u00e0 sa famille;- cliniques et th\u00e9rapeutiques relatives \u00e0 la maladie (LA): nature, \u00e2ge au moment du diagnostic, s\u00e9v\u00e9rit\u00e9, traitements, recul par rapport \u00e0 la gu\u00e9rison...;- concernant l'examen clinique et les s\u00e9quelles organiques \u00e9ventuelles: croissance saturo-pond\u00e9rale, pubert\u00e9 et fertilit\u00e9, thyro\u00efde, fonction cardiaque, fonction visuelle, tumeurs secondaires, contamination virales, fonction pulmonaire, m\u00e9tabolisme osseux, m\u00e9tabolisme du fer, syndrome m\u00e9tabolique, autres s\u00e9quelles (diab\u00e8te, ost\u00e9on\u00e9crose, Insuffisance r\u00e9nale chronique, alop\u00e9cie, Syst\u00e8me nerveux central...);- psycho-comportementales et cognitives- concernant la qualit\u00e9 de vie des sujets et de leurs proches;- concernant les relations du patient avec le syst\u00e8me de soins (acc\u00e8s aux soins et satisfaction)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Aujourd'hui l'ensemble du projet est pr\u00e9sent sur l'ensemble du territoire, repr\u00e9sent\u00e9 dans 18 centres d'h\u00e9matologie et oncologie p\u00e9diatriques, permettant de proposer le projet \u00e0 plus de 65% de la population concern\u00e9e."},"dataTypes":{"clinicalDataDetails":"relatives \u00e0 la maladie (LA) : nature, \u00e2ge au moment du diagnostic, s\u00e9v\u00e9rit\u00e9, traitements, recul par rapport \u00e0 la gu\u00e9rison. A la consultation de suivi: croissance staturo-pond\u00e9rale, pubert\u00e9 et fertilit\u00e9, thyro\u00efde, fonction cardiaque, fonction visuelle, tumeurs secondaires, contaminations virales, fonction pulmonaire, m\u00e9tabolisme osseux, m\u00e9tabolisme du fer, syndrome m\u00e9tabolique, autres s\u00e9quelles (diab\u00e8te, ost\u00e9on\u00e9crose, IRC, alop\u00e9cie, SNC\u2026) ;","biologicalDataDetails":"Dans le cadre du suivi m\u00e9dical des patients, des pr\u00e9l\u00e8vements sanguins sont r\u00e9alis\u00e9s et les donn\u00e9es concernant les param\u00e8tres biologiques usuels sont recueillies","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}