{"doc_desc":{"title":"Chronic toxicities in patients with early breast cancer","idno":"FRESH-PEF3082-en","producers":[{"name":"Fabrice ANDRE","affiliation":"INSTITUT GUSTAVE ROUSSY (IGR)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3082-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3082"},{"agency":"FReSH","code":"FRESH-PEF3082"}]},"title":"Chronic toxicities in patients with early breast cancer","alternate_title":"CANTO"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"adversed effects"},{"keyword":"long term toxicity"},{"keyword":"financial impact"},{"keyword":"predictors for chronic toxicity"},{"keyword":"toxicity"},{"keyword":"psychological impact"},{"keyword":"social impact"},{"keyword":"biomarkers"}],"topics":[{"topic":"Oncology","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":"Malignant neoplasms of breast","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"The primary goal will be to generate predictors of chronic toxicity in patients with early brest cancer treated with anticancer agents. This project will include four specific aims: - To develop a database of chronic toxicity in a cohort of 20 000 women with stage I-III breast cancer - To describe incidence, clinical presentation, biological characteristics and outcome of chronic toxicities - To describe the psychosocial and economic impact of chronic toxicities - To generates predictors for chronic toxicities","abstract":"","coll_dates":[{"start":"2012-01-01"}],"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\": \"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\": \"Women with non-metastasic breast cancer (I to III stade) treated in one of the 10 medical centers involved in the study\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Function testing']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[10000-20000[ individuals","response_rate":"20 000"},"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":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Ask the person in 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MDs will fill the questionnaire","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France territory"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}