{"doc_desc":{"title":"Cohorte Personnes Ag\u00e9es Multimorbidit\u00e9s pour le cancer du Sein","idno":"FRESH-PEF8125-fr","producers":[{"name":"Laure DE DECKER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8125-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8125"},{"agency":"FReSH","code":"FRESH-PEF8125"}]},"title":"Cohorte Personnes Ag\u00e9es Multimorbidit\u00e9s pour le cancer du Sein","alternate_title":"PAMS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Laure;DE DECKER","PILabo":"CHU de \/ Unit\u00e9 d\u2019Investigation clinique 19 \u2013 G\u00e9rontologie Clinique","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ORCID","uri":"0000-0002-9388-8824","role":"pi id"},{"title":"IdRef","uri":"08955762X","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"201223354M","role":"labo id"}],"email":"laure.dedecker@chu-nantes.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Laure;DE DECKER","email":"laure.dedecker@chu-nantes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"toxicit\u00e9s th\u00e9rapeutiques carcinologiques"},{"keyword":"comorbidit\u00e9"},{"keyword":"g\u00e9riatrie"}],"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":"G\u00e9riatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]},{"topic":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"Tumeurs malignes du sein","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L\u2019objectif principal de l\u2019\u00e9tude PAMS est de d\u00e9velopper un score pronostic de la survie \u00e0 5 ans des patientes \u00e2g\u00e9es de 65 ans et plus ayant un cancer du sein. Ce score sera constitu\u00e9 \u00e0 partir de variables caract\u00e9risant le cancer du sein, les caract\u00e9ristiques m\u00e9dico-psycho-sociales, le fardeau de morbidit\u00e9s, la fragilit\u00e9 et la qualit\u00e9 de vie. Les objectifs secondaires de l\u2019\u00e9tude PAMS seront: - Evaluer l\u2019influence du score pronostic dans les choix th\u00e9rapeutiques carcinologiques \u00e0 5 ans. - Evaluer l\u2019influence des param\u00e8tres g\u00e9riatriques analys\u00e9s individuellement dans les choix th\u00e9rapeutiques carcinologiques \u00e0 3 mois. Evaluer l\u2019influence de la qualit\u00e9 de vie sur la survie et l\u2019apparition de toxicit\u00e9s \u00e0 3 mois, 1 an et 5 ans.Evaluer l\u2019\u00e9volution de la qualit\u00e9 de vie des patientes \u00e0 3 mois (post th\u00e9rapeutique imm\u00e9diat) \u00e0 1 an (lors du traitement chronique et du suivi) et 5 ans. -Etudier les modifications de la perception (Response Shift) des questionnaires de qualit\u00e9 de vie au cours du temps, de mani\u00e8re \u00e0 distinguer dans l'analyse de l'\u00e9volution des scores de qualit\u00e9 de vie ce qui rel\u00e8ve d'un changement de perception et ce qui rel\u00e8ve d'une modification de la qualit\u00e9 de vie -Etudier les liens entre les modifications de la perception des questionnaires de qualit\u00e9 de vie au cours du temps et les scores au questionnaire d'impact du cancer (IOC). -Evaluer l\u2019\u00e9volution des performances physiques et de l\u2019autonomie des patientes \u00e0 3, 12 mois et 5 ans. -Evaluer la validit\u00e9 dans cette population du score de survie de Lee \u00e0 5 ans. -Evaluer les param\u00e8tres g\u00e9riatriques et carcinologiques associ\u00e9s \u00e0 un recours aux soins d\u00e9fini par une hospitalisation, non programm\u00e9, dans l\u2019ann\u00e9e suivant l\u2019inclusion, 3 mois, 1 an et 5 ans. -Evaluer l\u2019association entre l\u2019auto-questionnaire de sant\u00e9 et les param\u00e8tres d\u2019\u00e9valuation g\u00e9riatriques dans cette population. -D\u00e9terminer les associations entre le score pronostic, et la survenue de toxicit\u00e9s des th\u00e9rapeutiques carcinologiques \u00e0 5 ans. -D\u00e9terminer les associations entre les param\u00e8tres g\u00e9riatriques et la survenue de toxicit\u00e9s des th\u00e9rapeutiques carcinologiques, \u00e0 3 mois et 1 an. -D\u00e9terminer quelle est l\u2019\u00e9chelle de comorbidit\u00e9 la plus performante pour l'estimation de la tol\u00e9rance des th\u00e9rapeutiques propos\u00e9es aux patientes \u00e2g\u00e9es atteintes d\u2019un cancer du sein en stratifiant sur le type et le grade initial de la tumeur, ainsi que sur le choix th\u00e9rapeutique \u00e0 1 an.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\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\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Sujets \u00e2g\u00e9s de 65 ans et plus -Sujets ayant un cancer du sein confirm\u00e9 anatomopathologiquement -Sujets ayant donn\u00e9 et sign\u00e9 un consentement \u00e9clair\u00e9 de participation \u00e0 l\u2019\u00e9tude ou consentement \u00e9clair\u00e9 de son responsable l\u00e9gal. -Sujets affili\u00e9s \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale. -Sujets suivis par un centre de lutte contre le cancer ou un service de canc\u00e9rologie participant \u00e0 l\u2019\u00e9tude\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es 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sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"800"},"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":"Contacter le responsable scientifique","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":"19-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"Non","contributorName":"Laure DE DECKER","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"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 eCRF sera con\u00e7u par un data-manager, en conformit\u00e9 avec le 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g\u00e9nomiques.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}