{"doc_desc":{"title":"Etude r\u00e9trospective fran\u00e7aise d\u00e9crivant l'\u00e9pid\u00e9miologie et la prise en charge th\u00e9rapeutique des patientes trait\u00e9es par Herceptin\u00ae en n\u00e9oadjuvant pour un cancer du sein pr\u00e9coce HER2-positif","idno":"FRESH-PEF74138-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74138-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74138"},{"agency":"FReSH","code":"FRESH-PEF74138"}]},"title":"Etude r\u00e9trospective fran\u00e7aise d\u00e9crivant l'\u00e9pid\u00e9miologie et la prise en charge th\u00e9rapeutique des patientes trait\u00e9es par Herceptin\u00ae en n\u00e9oadjuvant pour un cancer du sein pr\u00e9coce HER2-positif","alternate_title":"KADOR"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Herceptin"}],"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":"Carcinome in situ du sein","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1264360394","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":"Objectif principal : D\u00e9crire la prise en charge th\u00e9rapeutique des patientes adultes atteintes d'un cancer du sein pr\u00e9coce HER2-positif ayant re\u00e7u un traitement adjuvant apr\u00e8s une th\u00e9rapie n\u00e9oadjuvante \u00e0 base d'Herceptin\u00ae et une chirurgie mammaire. Objectifs secondaires : Les 2 principaux objectifs secondaires sont : 1. D\u00e9crire les caract\u00e9ristiques cliniques des patientes incluses dans la cohorte, globalement et par statut de r\u00e9ponse pathologique ; 2. Mesurer la survie sans maladie invasive (IDFS) et la survie globale (OS), en fonction du statut de r\u00e9ponse pathologique. Autres objectifs : 3. Caract\u00e9riser les r\u00e9sultats de l'\u00e9chec du traitement adjuvant, y compris le d\u00e9c\u00e8s, la progression de la maladie et les rechutes ; 4. D\u00e9crire l'utilisation des ressources de soins de sant\u00e9 par les patientes cibl\u00e9es ; 5. Estimer le nombre de patientes atteintes d'un cancer du sein pr\u00e9coce HER2-positif ayant subi une chirurgie mammaire apr\u00e8s un traitement n\u00e9oadjuvant \u00e0 base d'Herceptin\u00ae en France sur une p\u00e9riode d'un an (gr\u00e2ce \u00e0 la constitution d'un registre de ces patientes), ainsi que le nombre de patientes atteintes d'un cancer du sein pr\u00e9coce HER2-positif n'ayant pas obtenu une r\u00e9ponse pathologique compl\u00e8te (pCR).","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2018-01-01"}],"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 (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            \"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\": \"Crit\u00e8res d'inclusion : - Diagnostic confirm\u00e9 de cancer du sein pr\u00e9coce HER2-positif ; - Traitement n\u00e9oadjuvant \u00e0 base d'Herceptin\u00ae initi\u00e9 en 2014 (p\u00e9riode d'inclusion) suivi d'une chirurgie mammaire ; - Une visite chez l'un des oncologues participant \u00e0 l'\u00e9tude au cours de la p\u00e9riode d'inclusion d'un an.  \",\n    \"clusion_E\": \"Les patientes atteintes d'un cancer du sein bilat\u00e9ral, ou participant \u00e0 un essai clinique de traitement n\u00e9oadjuvant ou adjuvant, ou d\u00e9j\u00e0 incluses dans le registre d'un autre site participant \u00e0 l'\u00e9tude, ou ayant exprim\u00e9 un d\u00e9saccord sur l'utilisation de leurs donn\u00e9es m\u00e9dicales seront exclues du registre du site.\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"301"},"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":"23-06-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Strat\u00e9gie de traitement n\u00e9oadjuvant et traitements non m\u00e9dicamenteux (chirurgie et radioth\u00e9rapie) - Strat\u00e9gie de traitement adjuvant et modification - Variables des crit\u00e8res d'inclusion, caract\u00e9ristiques d\u00e9mographiques, anthropom\u00e9triques, cliniques et canc\u00e9reuses - Poids, comorbidit\u00e9s d'int\u00e9r\u00eat au moment de l'initiation du traitement adjuvant - Date de la derni\u00e8re visite du patient au cours de la p\u00e9riode de suivi, progression de la maladie et raison de la fin pr\u00e9matur\u00e9e de l'observation ou du suivi - utilisation des ressources de soins de sant\u00e9 - date de d\u00e9but et de fin de l'inclusion du patient dans le registre - date d'inclusion du premier patient inclus et du dernier patient inclus dans le registre - nombre de consultations dans le site au cours de l'ann\u00e9e d'inclusion - traitement adjuvant par trastuzumab (oui\/non) - type de chirurgie et statut de la r\u00e9ponse anatomopathologique.","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}