{"doc_desc":{"title":"Cohorte de femmes atteintes d'un cancer du sein localis\u00e9 : \u00e9tude des toxicit\u00e9s chroniques des traitements anticanc\u00e9reux","idno":"FRESH-PEF3082-fr","producers":[{"name":"Fabrice ANDRE","affiliation":"INSTITUT GUSTAVE ROUSSY (IGR)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3082-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3082"},{"agency":"FReSH","code":"FRESH-PEF3082"}]},"title":"Cohorte de femmes atteintes d'un cancer du sein localis\u00e9 : \u00e9tude des toxicit\u00e9s chroniques des traitements anticanc\u00e9reux","alternate_title":"CANTO"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Fabrice;ANDRE","PILabo":"Institut Gustave Roussy \/ Inserm U981","affiliationName":"INSTITUT GUSTAVE ROUSSY (IGR)","extlink":[{"title":"ORCID","uri":"0000-0002-6272-6048","role":"pi id"},{"title":"IdRef","uri":"157634345","role":"pi id"},{"title":"SIREN","uri":"775741101","role":"organisation id"},{"title":"RNSR","uri":"201019142T","role":"labo id"}],"email":"fabrice.andre@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT GUSTAVE ROUSSY (IGR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0321g0743","role":"sponsor id"},{"title":"SIREN","uri":"775741101","role":"sponsor id"}],"role":"sponsor"},{"name":"UniCancer Group","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04vhgtv41","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":"BIOMERIEUX","extlink":[{"title":"SIREN","uri":"479090979"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"Fabrice;ANDRE","email":"fabrice.andre@inserm.fr","type":"contact","affiliationName":"INSTITUT GUSTAVE ROUSSY (IGR)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0321g0743","role":"organisation id","title":"ROR"},{"uri":"775741101","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Effets ind\u00e9sirables"},{"keyword":"Toxicit\u00e9 \u00e0 long terme"},{"keyword":"impact social"},{"keyword":"impact \u00e9conomique"},{"keyword":"mod\u00e8le de pr\u00e9diction"},{"keyword":"caract\u00e9ristiques cliniques"},{"keyword":"toxicit\u00e9"},{"keyword":"impact psychologique"},{"keyword":"biomarqueurs"}],"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":"Tumeurs malignes du sein","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","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 li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Cette cohorte a pour objectifs l'\u00e9tude des toxicit\u00e9s chroniques des traitements anticanc\u00e9reux chez des patientes atteintes d'un cancer du sein localis\u00e9. Le projet pr\u00e9sente quatre objectifs sp\u00e9cifiques: - R\u00e9pertorier les \u00e9v\u00e8nements ind\u00e9sirables survenus chez ces femmes et potentiellement li\u00e9s \u00e0 la toxicit\u00e9 chronique des traitements anti-canc\u00e9reux. - Description de la toxicit\u00e9 chronique de ces traitements (incidence, tableau clinique et biologique,..) - Description de l'impact psycho-social et \u00e9conomique des toxicit\u00e9s chroniques - D\u00e9veloppement de mod\u00e8les pr\u00e9dictifs de la toxicit\u00e9 chronique, \u00e0 partir de l'\u00e9tude des polymorphismes g\u00e9n\u00e9tiques (SNP arrays, variants genetiques) que des biomarqueurs s\u00e9riques (prot\u00e9ines, anticorps).","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\": \"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\": \"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            \"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\": \"Femmes atteintes de cancer du sein localis\u00e9 (stade I \u00e0 III) suivies dans l'un des 10 centres de traitements participant \u00e0 l'\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle']","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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"20 000"},"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":"Toute \u00e9quipe de recherche qui d\u00e9sire obtenir des donn\u00e9es devra soumettre sa demande au comit\u00e9 de collaboration. La demande sera \u00e9valu\u00e9e, si elle est consid\u00e9r\u00e9e comme de bonne qualit\u00e9 et approuv\u00e9e par le comit\u00e9 de pilotage, les donn\u00e9es demand\u00e9es seront extraites et envoy\u00e9es.","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":"31-01-2012","lastUpdatedAuto":null,"lastUpdatedManual":"18-01-2013","isContributorPI":"Non","contributorName":"Fabrice ANDRE","contributorAffiliation":"INSTITUT GUSTAVE ROUSSY (IGR)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif","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":"A l'inclusion: chaque femme remplira un premier questionnaire pour recueillir les informations d\u00e9mographiques, conditions de vie, aspects psychologiques, qualit\u00e9 de vie (QoL). Le m\u00e9decin traitant remplit un questionnaire consacr\u00e9 aux aspects m\u00e9dicaux: description clinique et biologiques, caract\u00e9ristiques du traitement. Au cours du suivi: - Report des \u00e9v\u00e8nements ind\u00e9sirables potentiellement li\u00e9s \u00e0 la toxicit\u00e9 des traitements mis en \u0153uvre: tout \u00e9v\u00e8nement toxique survenant pendant le traitement ou apr\u00e8s un d\u00e9lai de 3 mois suivant une chimioth\u00e9rapie, un acte de chirurgie ou de radioth\u00e9rapie. Le patient reportera lui m\u00eame tout trouble de sant\u00e9 constat\u00e9 sur un notebook d\u00e9di\u00e9. Les donn\u00e9es not\u00e9es seront retranscrites par les m\u00e9decins et infirmi\u00e8res participant \u00e0 l'\u00e9tude. Chaque patient pour lequel il est suspect\u00e9 une toxicit\u00e9 sera adress\u00e9 aux experts du centre hospitalier local pour une documentation d\u00e9taill\u00e9e de celle-ci - questionnaire \"baseline\" annuel au minimum, ou \u00e0 chaque visite - questionnaires ponctuels (radioth\u00e9rapie,...) - Les examens paracliniques seront r\u00e9alis\u00e9s sur n\u00e9cessit\u00e9 pour \u00e9tayer les \u00e9v\u00e8nements ind\u00e9sirables survenant ou lors d'une exposition \u00e0 un m\u00e9dicament particulier - Les \u00e9chantillons de sang seront collect\u00e9s \u00e0 l'inclusion et chaque ann\u00e9e.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France M\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}