{"doc_desc":{"title":"Prospective Breast and Ovarian Genetic Study: genetic predisposition to breast and ovarian cancer: a prospective study of BRCA mutation carriers","idno":"FRESH-PEF60053-en","producers":[{"name":"Catherine NOGUES","affiliation":"INSTITUT CURIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60053-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60053"},{"agency":"FReSH","code":"FRESH-PEF60053"}]},"title":"Prospective Breast and Ovarian Genetic Study: genetic predisposition to breast and ovarian cancer: a prospective study of BRCA mutation carriers","alternate_title":"GENEPSO"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Catherine;NOGUES","PILabo":"Centre Ren\u00e9 \/ U735","affiliationName":"INSTITUT CURIE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"030671175","role":"pi id"},{"title":"SIREN","uri":"784257164","role":"organisation id"},{"title":"RNSR","uri":"200518036M","role":"labo id"}],"email":"noguesc@ipc.unicancer.fr","isContact":"Yes"},{"type":"investigator","name":"Emmanuelle;FOURME","PILabo":"Centre Ren\u00e9","affiliationName":"INSTITUT CURIE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"073987557","role":"pi id"},{"title":"SIREN","uri":"784257164","role":"organisation id"},{"title":"RNSR","uri":"200616357H","role":"labo id"}],"email":"emmanuelle.fourme@curie.net","isContact":"Yes"}],"oth_id":[{"name":"","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT CURIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04t0gwh46","role":"sponsor id"},{"title":"SIREN","uri":"784257165","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FONDATION DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]}]},"distribution_statement":{"contact":[{"name":"Catherine;NOGUES","email":"noguesc@ipc.unicancer.fr","type":"contact","affiliationName":"INSTITUT CURIE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04t0gwh46","role":"organisation id","title":"ROR"},{"uri":"784257164","role":"organisation id","title":"SIREN"}]},{"name":"Emmanuelle;FOURME","email":"emmanuelle.fourme@curie.net","type":"contact","affiliationName":"INSTITUT CURIE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04t0gwh46","role":"organisation id","title":"ROR"},{"uri":"784257164","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"BRCA gene mutation"},{"keyword":"standardised collection"},{"keyword":"prospective follow-up"},{"keyword":"Health events"},{"keyword":"death"}],"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":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"General objective: to form a cohort of BRCA gene mutation carriers for standardised data collection and to establish a prospective follow-up over 10 years. Treatment for families can be improved by resolving certain questions (projects with associated INSERM teams): 1) what is the risk of developing breast and\/or ovarian cancer for gene mutation carriers during their lifetime? 2) are cancer risks modified by environmental factors (in particular medical radiation), hormonal factors (endogenous or exogenous), or other genetic factors? 3) should the same parameters be used to evaluate the prognosis of sporadic cancer? 4) what is the psychological and social impact for people with a known predisposition to breast and\/or ovarian cancer?","abstract":"","coll_dates":[{"start":"1999-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adult subjects with no mental disability who are BRCA genetic mutation carriers\",\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":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1425"},"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":"Data may be used by academic teams Data may be used by industrial 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