{"doc_desc":{"title":"\u00c9tude r\u00e9trospective visant \u00e0 caract\u00e9riser les patientes atteintes d'un cancer du sein m\u00e9tastatique ou localement avanc\u00e9 HER2-positif, trait\u00e9es par Herceptin\u00ae en 1\u00e8re ligne et sans progression depuis au moins 3 ans, suivie d'une \u00e9tude prospective d'un an pour les patientes encore en vie.","idno":"FRESH-PEF74136-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74136-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74136"},{"agency":"FReSH","code":"FRESH-PEF74136"},{"agency":"NCT","code":"NCT01480674"}]},"title":"\u00c9tude r\u00e9trospective visant \u00e0 caract\u00e9riser les patientes atteintes d'un cancer du sein m\u00e9tastatique ou localement avanc\u00e9 HER2-positif, trait\u00e9es par Herceptin\u00ae en 1\u00e8re ligne et sans progression depuis au moins 3 ans, suivie d'une \u00e9tude prospective d'un an pour les patientes encore en vie.","alternate_title":"LORHA"},"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 : Cette \u00e9tude observationnelle caract\u00e9risera r\u00e9trospectivement les patientes atteintes d'un cancer du sein m\u00e9tastatique ou localement avanc\u00e9 HER2-positif qui ont re\u00e7u un traitement par Herceptin (trastuzumab) en 1\u00e8re ligne et qui n'ont pas connu de progression pendant au moins trois ans. Objectifs secondaires : Les objectifs secondaires de cette \u00e9tude \u00e9taient de d\u00e9crire : - La survie sans progression, le temps jusqu'\u00e0 la progression et la survie globale des patients ; - Les modalit\u00e9s d'utilisation du trastuzumab, la dur\u00e9e du traitement et les raisons conduisant \u00e0 l'arr\u00eat du traitement ; - Les traitements antin\u00e9oplasiques en association avec le trastuzumab et apr\u00e8s l'arr\u00eat du traitement au trastuzumab ; - les marqueurs biologiques tumoraux pertinents ; - La s\u00e9curit\u00e9 du traitement par le trastuzumab.","abstract":"","coll_dates":[{"start":"2011-01-01","end":"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 (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 : - Femme >= 18 ans ; - Atteinte d'un cancer du sein m\u00e9tastatique HER2-positif ou d'un cancer du sein localement avanc\u00e9 ; - Trait\u00e9e par trastuzumab en premi\u00e8re intention ; - Sans progression pendant au moins 3 ans apr\u00e8s le d\u00e9but du traitement au trastuzumab ; - Vivantes ou non, et trait\u00e9es ou non par trastuzumab au moment de l'inclusion ; Pour les patients en vie au moment de l'inclusion : - Ayant \u00e9t\u00e9 inform\u00e9es oralement et par \u00e9crit de l'\u00e9tude et ayant donn\u00e9 leur consentement \u00e9crit au traitement automatis\u00e9 de leurs donn\u00e9es personnelles et \u00e0 leur consultation par un tiers d\u00fbment autoris\u00e9 ; - Pour les patients ayant accept\u00e9 l'analyse histologique centralis\u00e9e de leur tumeur primitive, un consentement \u00e9crit.  \",\n    \"clusion_E\": \"Progression de la maladie <3 ans apr\u00e8s le d\u00e9but du traitement de 1\u00e8re ligne par Herceptin\"\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":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation 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":"160"},"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":"crit\u00e8res d'\u00e9valuation\/d'inclusion - diagnostic initial du cancer du sein - traitements n\u00e9o-adjuvants - traitements adjuvants - entr\u00e9e en phase m\u00e9tastatique ou localement avanc\u00e9e - effets ind\u00e9sirables depuis l'initiation du traitement par Herceptin\u00ae - Progression de la maladie - Evaluation \u00e0 M6 et M12 - chimioth\u00e9rapie en 1\u00e8re, 2\u00e8me et 3\u00e8me lignes - hormonoth\u00e9rapie en 1\u00e8re, 2\u00e8me et 3\u00e8me lignes - Progression apr\u00e8s 1 et 2\u00e8me lignes - traitement par Herceptin\u00ae en n\u00e9o-adjuvant\/adjuvant - traitement par Herceptin\u00ae en phase m\u00e9tastatique","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"}