{"doc_desc":{"title":"Cohort of Breast Cancer Patients. Identification of Genetic Determinants that Influence Resistance\/Sensitivity and\/or Toxicity to Adjuvant Cancer Treatment and Genetic Determinants for Developing Breast Cancer.","idno":"FRESH-PEF73302-en","producers":[{"name":"Jacques ROPERS","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73302-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73302"},{"agency":"FReSH","code":"FRESH-PEF73302"}]},"title":"Cohort of Breast Cancer Patients. Identification of Genetic Determinants that Influence Resistance\/Sensitivity and\/or Toxicity to Adjuvant Cancer Treatment and Genetic Determinants for Developing Breast Cancer.","alternate_title":"SIGNAL"},"study_authorization":{"agency":[]},"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":"Yes"},{"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 id"},{"title":"IdRef","uri":"199292183","role":"pi id"},{"title":"SIREN","uri":"333466407","role":"organisation 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Centre","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"167710214","role":"pi id"},{"title":"SIREN","uri":"196917744","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"david.cox@inserm.fr","isContact":"Yes"}],"oth_id":[{"name":"ICGC (International Consortium of Genomics of Cancer)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32","role":"sponsor id"},{"title":"SIREN","uri":"187512777","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DU CANCER (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 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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":"Malignant neoplasms of breast","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The aims of this study are: \u2014 to identify determinants that influence resistance or sensitivity following adjuvant treatment with Herceptin\u00ae; \u2014 to identify determinants of cardiac toxicity following adjuvant treatment with Herceptin\u00ae; \u2014 to identify genetic determinants for developing different types of breast cancer: HER2+, triple negative, RH+; \u2014 to identify genetic determinants for developing breast cancer.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"1. Women over 18 years old.  2. Histologically confirmed, non-metastatic, operable breast adenocarcinoma. 3. HER2+ tumour: all patients undergoing adjuvant treatment with Trastuzumab.  4. Signed informed consent.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Implemented by independent operators']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Free access","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"9,600"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"Fully anonymised clinical data (no initials or order number; returned to correlation table; no date of birth; no reference to the healthcare centre or investigator that enrolled the patient)","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"may be made readily available to third parties: please contact those in charge of the study.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":"Requesting parties undertake to reference the study and its sponsor in all publications resulting from these data."},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"13-01-2016","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2016","isContributorPI":"No","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":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"By participating physicians and study investigators","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Type of treatment received; breast cancer subtype; clinical events (relapse, death); heart monitoring.","biologicalDataDetails":"Blood; tumour sample","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}