{"doc_desc":{"title":"Cohorte prospective de patientes trait\u00e9es par chimioth\u00e9rapie n\u00e9oadjuvante pour un cancer mammaire","idno":"FRESH-PEF60092-fr","producers":[{"name":"Fran\u00e7ois GHIRINGHELLI","affiliation":"CENTR GEORGES FRANCOIS LECLERC"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60092-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60092"},{"agency":"FReSH","code":"FRESH-PEF60092"}]},"title":"Cohorte prospective de patientes trait\u00e9es par chimioth\u00e9rapie n\u00e9oadjuvante pour un cancer mammaire","alternate_title":"CHIMIOTHERAPIE CANCER MAMMAIRE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Fran\u00e7ois;GHIRINGHELLI","PILabo":"","affiliationName":"CENTR GEORGES FRANCOIS LECLERC","extlink":[{"title":"ORCID","uri":"0000-0002-5465-8305","role":"pi id"},{"title":"IdRef","uri":"098797387","role":"pi id"},{"title":"SIREN","uri":"778204271","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"francois.ghiringhelli@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"sponsor id"},{"title":"SIREN","uri":"262100076","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTR GEORGES FRANCOIS LECLERC","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pjqzf38"},{"title":"SIREN","uri":"778204271"}]}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;GHIRINGHELLI","email":"francois.ghiringhelli@inserm.fr","type":"contact","affiliationName":"CENTR GEORGES FRANCOIS LECLERC","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pjqzf38","role":"organisation id","title":"ROR"},{"uri":"778204271","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9tat"},{"keyword":"d\u00e9c\u00e9d\u00e9"},{"keyword":"rechutes locales"},{"keyword":"m\u00e9tastatiques"},{"keyword":"donn\u00e9es histologiques"},{"keyword":"classification"},{"keyword":"imagerie"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"traitement"},{"keyword":"chirurgie"}],"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 li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00c9valuer les caract\u00e9ristiques m\u00e9dicales, cliniques, biologiques et th\u00e9rapeutiques des patientes ayant un cancer du sein recevant une chimioth\u00e9rapie n\u00e9oadjuvante Objectifs secondaires : - \u00c9valuer l\u2019impact \u00e0 long terme de ces sch\u00e9mas th\u00e9rapeutique sur les survies globales et sans r\u00e9cidives ; - Valider les scores pronostiques actuels issus d\u2019une population am\u00e9ricaine sur une cohorte fran\u00e7aise ind\u00e9pendante ; - Identifier les variables pronostiques et de s\u00e9lectionner celles pertinentes pour la constitution et l\u2019\u00e9valuation d\u2019un nouveau score issu de notre base de donn\u00e9es tenant compte des nouvelles donn\u00e9es biologiques (scores de Chevallier et Sataloff et classification mol\u00e9culaire) ; - Comparer les qualit\u00e9s pronostiques du nouveau score \u00e0 celles du score am\u00e9ricain ; - R\u00e9aliser une validation externe de ces scores (gr\u00e2ce \u00e0 une collaboration avec l\u2019\u00e9quipe de l\u2019institut Gustave Roussy \u00e0 Villejuif et l\u2019\u00e9quipe de l\u2019institut Bergonie \u00e0 Bordeaux) ; - Isoler des facteurs g\u00e9n\u00e9tiques (constitutionnel), g\u00e9nomiques (tumoraux) ou immunohistologiques ayant un pouvoir pr\u00e9dictif de la r\u00e9ponse au traitement et pronostic.","abstract":"","coll_dates":[{"start":"1990-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bourgogne Franche-Comt\u00e9']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" patiente ayant un cancer du sein trait\u00e9 pour chimioth\u00e9rapie n\u00e9oadjuvante ; - accord \u00e9crit de la patiente.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['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 au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers un tiers Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits de qualit\u00e9 internes 1 fois par an Autre(s) proc\u00e9dure(s) qualit\u00e9 : TIRAGE AU SORT DE 10% DES DOSSIERS ET VALIDATIONS PAR DES DONNEES SAISIES PAR 1 EXPERT CLINICIEN ET 1 EXPERT METHODOLOGISTE Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"465"},"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 non possible des donn\u00e9es par des industriels","conditions":"Condition d&#x27;acc\u00e8s la partie biologique de l\u2019etude est realise dans les unites inserm u866 (pr eric solary, dr ghiringhelli) a dijon et a l\u2019inserm 645 de besan\u00e7on","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":"04-08-2014","isContributorPI":"Non","contributorName":"Fran\u00e7ois GHIRINGHELLI","contributorAffiliation":"CENTR GEORGES FRANCOIS LECLERC","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21750556"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"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":"Examens cliniques : Saisie directe Examens biologiques : Saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Bourgogne"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : Biopsie initiale et pr\u00e9l\u00e9vement chirurgical (conservation en cong\u00e9lation et paraffine) serum","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}