{"doc_desc":{"title":"\u00c9tude de cohorte de patients atteints d'un cancer colorectal m\u00e9tastatique et trait\u00e9s par Avastin\u00ae en premi\u00e8re intention pour des m\u00e9tastases h\u00e9patiques consid\u00e9r\u00e9es comme potentiellement r\u00e9s\u00e9cables","idno":"FRESH-PEF74087-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74087-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74087"},{"agency":"FReSH","code":"FRESH-PEF74087"},{"agency":"NCT","code":"NCT01343901"}]},"title":"\u00c9tude de cohorte de patients atteints d'un cancer colorectal m\u00e9tastatique et trait\u00e9s par Avastin\u00ae en premi\u00e8re intention pour des m\u00e9tastases h\u00e9patiques consid\u00e9r\u00e9es comme potentiellement r\u00e9s\u00e9cables","alternate_title":"PICASSO"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"bevacizumab"}],"topics":[{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Tumeurs malignes, d\u00e9clar\u00e9es ou suppos\u00e9es primitives, de localisations pr\u00e9cis\u00e9es, \u00e0 l'exception des tissus lympho\u00efde, h\u00e9matopo\u00ef\u00e9tique, du syst\u00e8me nerveux central ou de tissus apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","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 principal : \u00e9valuer l'efficacit\u00e9 et l'innocuit\u00e9 du bevacizumab en tant que traitement de premi\u00e8re intention chez les participants atteints de cancer colorectal et de m\u00e9tastases h\u00e9patiques potentiellement r\u00e9s\u00e9cables. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par Avastin\u00ae, - D\u00e9crire le sous-groupe de patients pr\u00e9sentant des m\u00e9tastases manquantes non r\u00e9s\u00e9qu\u00e9es, avec ou sans chirurgie, - D\u00e9crire les crit\u00e8res utilis\u00e9s pour d\u00e9finir l'absence de r\u00e9section, - D\u00e9crire la survie sans progression chez tous les patients, - D\u00e9crire la survie sans r\u00e9cidive chez tous les patients r\u00e9s\u00e9qu\u00e9s ne pr\u00e9sentant pas de maladie m\u00e9tastatique d\u00e9tectable, - D\u00e9crire la survie globale chez tous les patients, - D\u00e9crire la r\u00e9ponse histopathologique chez les patients r\u00e9s\u00e9qu\u00e9s, - D\u00e9crire les modalit\u00e9s de traitement par Avastin\u00ae, - D\u00e9crire le profil de s\u00e9curit\u00e9 d'Avastin\u00ae.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2015-01-01"}],"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            \"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            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion :\\n- Homme ou femme \u00e2g\u00e9 de 18 ans ou plus,\\n- Diagnostiqu\u00e9 avec un ad\u00e9nocarcinome du colon ou du rectum incluant exclusivement des m\u00e9tastases h\u00e9patiques ou h\u00e9patiques et pulmonaires,\\n- Pour lequel un traitement de premi\u00e8re ligne par Avastin\u00ae a \u00e9t\u00e9 mis en place dans le cadre d'une maladie m\u00e9tastatique potentiellement r\u00e9s\u00e9cable\\n- Qui a \u00e9t\u00e9 inform\u00e9 oralement et par \u00e9crit de l'\u00e9tude, de ses objectifs et de ses modalit\u00e9s de mise en \u0153uvre et qui ne s'est pas oppos\u00e9 \u00e0 ce que les donn\u00e9es recueillies fassent l'objet d'un traitement automatis\u00e9.\",\n    \"clusion_E\": \"des m\u00e9tastases h\u00e9patiques ou h\u00e9patiques et pulmonaires, - Pour lequel un traitement de premi\u00e8re ligne par Avastin\u00ae a \u00e9t\u00e9 mis en place dans le cadre d'une maladie m\u00e9tastatique potentiellement r\u00e9s\u00e9cable, - Qui a \u00e9t\u00e9 inform\u00e9 oralement et par \u00e9crit de l'\u00e9tude, de ses objectifs et de ses modalit\u00e9s de mise en \u0153uvre et qui ne s'est pas oppos\u00e9 \u00e0 ce que les donn\u00e9es recueillies fassent l'objet d'un traitement automatis\u00e9  : - Patient consid\u00e9r\u00e9 comme r\u00e9s\u00e9cable d'embl\u00e9e \u00e0 l'inclusion, - Patient consid\u00e9r\u00e9 comme ne pouvant jamais \u00eatre r\u00e9s\u00e9cable, - Patient d\u00e9j\u00e0 inclus dans une \u00e9tude clinique portant sur un m\u00e9dicament anticanc\u00e9reux cytotoxique et\\\/ou une th\u00e9rapie innovante\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"['similaire \u00e0 CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"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 les professionnels d&#x27;exercice lib\u00e9ral']"}},"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":"218"},"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":"","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":"02-11-2021","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}