{"doc_desc":{"title":"Cohorte de patientes atteintes d'un cancer du sein. Identification de d\u00e9terminants g\u00e9n\u00e9tiques de r\u00e9sistance\/sensibilit\u00e9 et\/ou de toxicit\u00e9 aux traitements en situation adjuvante et de d\u00e9terminants g\u00e9n\u00e9tiques pr\u00e9disposant au cancer du sein","idno":"FRESH-PEF73302-fr","producers":[{"name":"Jacques ROPERS","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73302-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73302"},{"agency":"FReSH","code":"FRESH-PEF73302"}]},"title":"Cohorte de patientes atteintes d'un cancer du sein. Identification de d\u00e9terminants g\u00e9n\u00e9tiques de r\u00e9sistance\/sensibilit\u00e9 et\/ou de toxicit\u00e9 aux traitements en situation adjuvante et de d\u00e9terminants g\u00e9n\u00e9tiques pr\u00e9disposant au cancer du sein","alternate_title":"SIGNAL"},"study_authorization":{"agency":[{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"H\u00e9l\u00e8ne;BLANCHE-KOCH","PILabo":"Fondation Jean Dausset-CEPH","affiliationName":"CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"333466407","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"blanche@cephb.fr","isContact":"Oui"},{"type":"investigator","name":"Jean-Fran\u00e7ois;DELEUZE","PILabo":"Fondation Jean Dausset-CEPH","affiliationName":"CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)","extlink":[{"title":"ORCID","uri":"0000-0002-5358-4463","role":"pi 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(INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"H\u00e9l\u00e8ne;BLANCHE-KOCH","email":"blanche@cephb.fr","type":"contact","affiliationName":"CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01rje3r53","role":"organisation id","title":"ROR"},{"uri":"333466407","role":"organisation id","title":"SIREN"}]},{"name":"Jean-Fran\u00e7ois;DELEUZE","email":"deleuze@cng.fr","type":"contact","affiliationName":"CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01rje3r53","role":"organisation id","title":"ROR"},{"uri":"333466407","role":"organisation id","title":"SIREN"}]},{"name":"Xavier;PIVOT","email":"xpivot@strasbourg.unicancer.fr","type":"contact","affiliationName":"CHU BESANCON (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0084te143","role":"organisation id","title":"ROR"},{"uri":"262501760","role":"organisation id","title":"SIREN"}]},{"name":"C\u00e9line;FAURE-MERCIER","email":"cfaure@institutcancer.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DU CANCER (INCA)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03m8vkq32","role":"organisation id","title":"ROR"},{"uri":"187512777","role":"organisation id","title":"SIREN"}]},{"name":"David;COX","email":"david.cox@inserm.fr","type":"contact","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"determinant g\u00e9n\u00e9tique"},{"keyword":"cancer"},{"keyword":"sein"},{"keyword":"traitement"}],"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 biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux 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":"Cette \u00e9tude comporte les objectifs suivants : - identifier des d\u00e9terminants de r\u00e9sistance ou sensibilit\u00e9 apr\u00e8s un traitement adjuvantincluant l\u2019Herceptin\u00ae ; - identifier des d\u00e9terminants de toxicit\u00e9 cardiaque apr\u00e8s un traitement adjuvant incluantl\u2019Herceptin\u00ae ; - identifier des d\u00e9terminants g\u00e9n\u00e9tiques pr\u00e9disposant \u00e0 diff\u00e9rents types du cancer dusein : HER2+, triple n\u00e9gatif, RH+ ; - identifier des d\u00e9terminants g\u00e9n\u00e9tiques pr\u00e9disposant au cancer du sein","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2017-01-01"}],"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\": \"1. Femme de plus de 18 ans. 2. Ad\u00e9nocarcinome du sein confirm\u00e9 histologiquement, non m\u00e9tastatique et op\u00e9rable. 3. Tumeur HER2+ : toutes les patientes trait\u00e9es en adjuvant par trastuzumab. 4. Consentement \u00e9clair\u00e9 sign\u00e9.\",\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":"['saisie par des op\u00e9rateurs ind\u00e9pendants']"}},"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 libre","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"9600"},"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":"Les donn\u00e9es cliniques enti\u00e8rement anonymis\u00e9es (pas d\u2019initiale, pas de num\u00e9ro d\u2019ordre renvoyant \u00e0 une table de correspondance, pas de date de naissance, aucune mention relative au centre de soins ou investigateur ayant inclus la patiente)","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Les donn\u00e9es pourront \u00eatre mises \u00e0 disposition de tiers rapidement, merci de prendre contact avec les responsables de l'\u00e9tude.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":"Les demandeurs s'engagent \u00e0 mentionner l'\u00e9tude et son promoteur dans toute publication issue de l'exploitation de ces donn\u00e9es"},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"13-01-2016","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2016","isContributorPI":"Non","contributorName":"Jacques ROPERS","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"Par les m\u00e9decins participants et les investigateurs de l'\u00e9tude","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Type de traitement re\u00e7u, sous-type cancer du sein, \u00e9v\u00e9nements cliniques (rechute, d\u00e9c\u00e8s), suivi cardiaque.","biologicalDataDetails":"Sang, pr\u00e9l\u00e8vement tumoral","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}