{"doc_desc":{"title":"Cohorte de patientS atteints d'un cancer colorectal","idno":"FRESH-PEF6922-fr","producers":[{"name":"Lucien ABENHAIM","affiliation":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6922-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"6922"},{"agency":"FReSH","code":"FRESH-PEF6922"}]},"title":"Cohorte de patientS atteints d'un cancer colorectal","alternate_title":"FDRK: Feuille de route cancer du colon"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Lucien;ABENHAIM","PILabo":"LASER \/ INSERM U657","affiliationName":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"072306513","role":"pi id"},{"title":"SIREN","uri":"450195979","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","extlink":[{"title":"SIREN","uri":"450195979","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"progression tumorale"},{"keyword":"maladie m\u00e9tastatique initiale"},{"keyword":"r\u00e9cidive tumorale locale"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"m\u00e9tastases"},{"keyword":"d\u00e9c\u00e8s"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"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":"Certaines affections des voies respiratoires inf\u00e9rieures","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1582386590","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : 1. D\u00e9crire les modes de prise en charge en france de 1360 patients pr\u00e9sentant un cancer colorectal diagnostiqu\u00e9 entre 2006 et 2008 2. D\u00e9crire la survie globale \u00e0 5 ans en fonction de modes de prise en charge initiale Objectifs secondaires : - d\u00e9crire les populations-cibles et les profils d\u2019utilisation de la chimioth\u00e9rapie ; - d\u00e9crire les profils d\u2019utilisation selon les types de centres ; - d\u00e9crire les \u00ab outcomes \u00bb suivants \u00e0 12, 36 et 60 mois : survie sans progression tumorale et la qualit\u00e9 de vie.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2013-01-01"}],"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\": \" adenocarcinome primitif avec confirmation histologique du colon ou du haut rectum (> 10 cm de la marge anale, haut rectum sus-p\u00e9riton\u00e9al inclus); - cas incident (diagnostic histologique du cancer colique <= 3 mois, avec ou sans m\u00e9tastases); - patient \u00e2g\u00e9 de 18 ans ou plus.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","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 ou retour vers un tiersRelance des m\u00e9decins pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits qualit\u00e9 internes par les ARC de l\\'\u00e9quipe dans tous les centres, 1 fois par anLes 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\":\"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":"1360"},"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 : condition d&#x27;acc\u00e8s pour tout etudiant de doctorat accepte dans l&#x27;equipe de haut niveau (inserm). Utilisation possible des donn\u00e9es par des industriels : condition d&#x27;acc\u00e8s acces de donnees agregees et anonymisees a roche.","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":"05-07-2013","lastUpdatedAuto":null,"lastUpdatedManual":"20-08-2014","isContributorPI":"Non","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.nature.com\/bjc\/journal\/v81\/n1\/abs\/6690651a.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Autoquestionnaire : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) Examens cliniques : Etape manuscrite (Saisie manuelle)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (97 centres) fran\u00e7aise"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les deux ans.Informations recueillies lors de l'examen clinique : investigateurs et\/ou assistants en recherche clinique recueillentQuestionnaire m\u00e9dical \u00e0 l\u2019inclusion recueille les informations suivantes :- identification ;- criteres d\u2019\u00e9ligibilite ;- donn\u00e9es sociod\u00e9mographiques ; - circonstances de la d\u00e9couverte ;- preuve histologique du cancer du colon (date et moyen d\u2019obtention) ;- recours aux soins au cours des 3 derniers mois ; - pr\u00e9disposition familiale au cancer colique ;- ant\u00e9c\u00e9dents et maladies associ\u00e9es ;- caract\u00e9ristiques de la tumeur primitive de colon ;- traitements de la tumeur primitive et de ses m\u00e9tastases : - intervention chirurgicale ; - traitement par chimioth\u00e9rapie et th\u00e9rapie cibl\u00e9e, chimioth\u00e9rapie adjuvante du cancer m\u00e9tastatique (dans un essai oui\/non); pour chaque protocole : date d\u00e9but \/ de fin, motifs d\u2019arr\u00eat code ; distance lieu d\u2019habitation\/lieu de traitement; mode de d\u00e9placement principal ; h\u00f4pital de jour\/ hospitalisation compl\u00e8te) ; - radioth\u00e9rapie ; - autres prises en charge li\u00e9es \u00e0 la tumeur.- modalit\u00e9s d\u2019annonce et organisation de la prise en chargeQuestionnaire m\u00e9dical de suivi recueille les informations suivantes :- statut dans la cohorte (patient vivant \/ perdu de vue \/ d\u00e9c\u00e9d\u00e9) ;- patient vivant\/perdu de vue : - apparition de m\u00e9tastases chez un patient initialement non m\u00e9tastatique ; - progression de la maladie m\u00e9tastatique initiale ; - r\u00e9cidive tumorale locale ; - r\u00e9mission compl\u00e8te ; - autre cancer primitif (localisation, date de diagnostic).- patient d\u00e9c\u00e9d\u00e9 (date, causes de d\u00e9c\u00e8s, d\u00e9c\u00e8s en rapport avec l\u2019\u00e9volution du cancer colorectal, d\u00e9c\u00e8s toxique) ;- surveillance de la maladie colorectale au cours des 6 derniers mois ;- traitements au cours des 6 derniers mois : - chirurgie ; - chimioth\u00e9rapie ; - radioth\u00e9rapie.Autre prise en charge","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"}