{"doc_desc":{"title":"Cohorte de patients atteints de cancer colorectal m\u00e9tastatique ayant commenc\u00e9 une chimioth\u00e9rapie en association avec Avastin\u00ae.","idno":"FRESH-PEF74088-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74088-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74088"},{"agency":"FReSH","code":"FRESH-PEF74088"},{"agency":"NCT","code":"NCT02612077"}]},"title":"Cohorte de patients atteints de cancer colorectal m\u00e9tastatique ayant commenc\u00e9 une chimioth\u00e9rapie en association avec Avastin\u00ae.","alternate_title":"CONCERT"},"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","email":"data_sharing.france@roche.com","type":"contact","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":"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":"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 : \u00c9valuer en conditions r\u00e9elles la survie sans progression de la maladie (PFS) avec un suivi maximal de 36 mois, chez des patients atteints de cancer colorectal m\u00e9tastatique et initiant un traitement par Avastin\u00ae combin\u00e9 \u00e0 une chimioth\u00e9rapie. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par Avastin\u00ae. - D\u00e9crire l'utilisation d'Avastin\u00ae au cours de la p\u00e9riode d'\u00e9tude. - \u00c9valuer la survie globale des patients trait\u00e9s par Avastin\u00ae. - D\u00e9crire le profil de s\u00e9curit\u00e9 d'Avastin\u00ae (effets ind\u00e9sirables graves et\/ou inattendus li\u00e9s \u00e0 Avastin\u00ae, et\/ou effets ind\u00e9sirables d'int\u00e9r\u00eat particulier). - D\u00e9crire la qualit\u00e9 de vie des patients trait\u00e9s par Avastin\u00ae. Objectif exploratoire : Une recherche des facteurs pronostiques de la survie sans progression de la maladie et de la survie globale a \u00e9t\u00e9 r\u00e9alis\u00e9e \u00e0 l'aide d'un mod\u00e8le de Cox chez les patients trait\u00e9s en 1\u00e8re ligne de chimioth\u00e9rapie (globalement et dans le sous-groupe des patients ayant des m\u00e9tastases synchrones). Ces facteurs ont \u00e9t\u00e9 d\u00e9termin\u00e9s \u00e0 partir des caract\u00e9ristiques des patients \u00e0 l'inclusion.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2012-01-01"}],"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 : - Patient adulte (\u00e2g\u00e9 de >= 18 ans) - Patient souffrant d'un carcinome colique ou rectal m\u00e9tastatique pour lequel le m\u00e9decin a d\u00e9cid\u00e9 de commencer un traitement par Avastin\u00ae combin\u00e9 \u00e0 une chimioth\u00e9rapie, au moment de l'inclusion. - Patient ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude et ne s'\u00e9tant pas oppos\u00e9 au traitement de ses donn\u00e9es personnelles. \",\n    \"clusion_E\": \"Participation \u00e0 un essai clinique visant \u00e0 \u00e9valuer un traitement anticanc\u00e9reux cytotoxique et\\\/ou une th\u00e9rapie innovante\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\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":[]},"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'exercice lib\u00e9ral']"}},"coll_mode":["{\"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":"[500-1000[ individus","response_rate":"765"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"Non","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"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":"questionnaire papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Type de donn\u00e9es collect\u00e9es : validation des crit\u00e8res de s\u00e9lection, informations sur l'\u00e9tude, donn\u00e9es d\u00e9mographiques et g\u00e9n\u00e9rales, histoire de la maladie, traitements ant\u00e9rieurs du cancer colorectal, derniers tests de laboratoire disponibles, traitement par Avastin\u00ae et chimioth\u00e9rapie combin\u00e9e, autres traitements, premi\u00e8re progression de la maladie, chirurgie du cancer colorectal, r\u00e9sultats rapport\u00e9s par le patient, raison de l'arr\u00eat pr\u00e9matur\u00e9 de l'\u00e9tude, effets ind\u00e9sirables li\u00e9s \u00e0 l'Avastin\u00ae.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}