{"doc_desc":{"title":"Cohorte de sujets portant une mutation des g\u00e8nes BRCA: pr\u00e9dispositions g\u00e9n\u00e9tiques aux cancers du sein et de l'ovaire","idno":"FRESH-PEF60053-fr","producers":[{"name":"Catherine NOGUES","affiliation":"INSTITUT CURIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60053-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60053"},{"agency":"FReSH","code":"FRESH-PEF60053"}]},"title":"Cohorte de sujets portant une mutation des g\u00e8nes BRCA: pr\u00e9dispositions g\u00e9n\u00e9tiques aux cancers du sein et de l'ovaire","alternate_title":"GENEPSO : G\u00e8ne \u00c9tude Prospective Sein Ovaire"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"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":"Oui"},{"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":"Oui"}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : IBCCS, GEN-RAD-RISC","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"mutation d'un g\u00e8ne BRCA"},{"keyword":"recueil standardis\u00e9"},{"keyword":"suivi prospectif"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"d\u00e9c\u00e8s"}],"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":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : mettre en place une cohorte de personnes porteuses d'une mutation d'un g\u00e8ne BRCA permettant un recueil standardis\u00e9 de donn\u00e9es et l'\u00e9tablissement d'un suivi prospectif sur 10 ans. La prise en charge des familles pourra \u00eatre am\u00e9lior\u00e9e par la r\u00e9solution de certaines questions (projets avec les \u00e9quipes Inserm associ\u00e9es) : 1) quel est le risque qu'un sujet porteur d'une mutation d\u00e9veloppe un cancer du sein et\/ou de l'ovaire et\/ou un autre cancer au cours de sa vie ? 2) ces risques de cancer sont-ils modifi\u00e9s par des facteurs environnementaux (en particulier les radiations m\u00e9dicales), des facteurs hormonaux (endog\u00e8nes ou exog\u00e8nes), d'autres facteurs g\u00e9n\u00e9tiques ? 3) doit-on utiliser les m\u00eames param\u00e8tres pour \u00e9valuer le pronostic des cancers sporadiques ? 4) quel est l'impact psychologique et social pour une personne de se savoir pr\u00e9dispos\u00e9e au cancer du sein et\/ou de l'ovaire ?","abstract":"","coll_dates":[{"start":"1999-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Sujets majeurs, sans incapacit\u00e9 mentale, et porteurs d'une mutation des g\u00e8nes brca\",\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":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques. Gestion des donn\u00e9es manquantes par retour au dossier source.Requ\u00eates de coh\u00e9rence r\u00e9alis\u00e9es tous les mois, les donn\u00e9es erron\u00e9es ou manquantes sont envoy\u00e9es aux investigateurs. Correction des donn\u00e9es de genepso lorsque elles sont envoy\u00e9es au sein de la cohorte internationale, retour a l\\'\u00e9quipe de genepso.']"}},"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"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1425"},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"05-08-2014","isContributorPI":"Non","contributorName":"Catherine NOGUES","contributorAffiliation":"INSTITUT CURIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/GENEPSO"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (29 centres en France)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi Informations recueillies lors de l'examen clinique : - \u00e0 l'inclusion : raison pour laquelle la mutation a \u00e9t\u00e9 recherch\u00e9e, type et description de la mutation d\u00e9l\u00e9t\u00e8re, description des cancers familiaux, arbre g\u00e9n\u00e9alogique.- au cours du suivi : livrets cliniques remplis par l'oncologue \u00e0 chaque \u00e9v\u00e9nement : cancer, rechute, d\u00e9c\u00e8s, chirurgie programm\u00e9e. Caract\u00e9ristiques cliniques et traitement initial, caract\u00e9ristiques histologiques et autres facteurs pronostiques, chirurgie, chimioth\u00e9rapie, radioth\u00e9rapie, hormonoth\u00e9rapie, pr\u00e9l\u00e8vements tumoraux (existance, conditions de stockage), rechute et traitements des rechutes.","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : Sang, tissu tumoral","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}