{"doc_desc":{"title":"Analyse prospective de la morbi-mortalit\u00e9 des patients atteints de cancer en phase active de traitement suspect\u00e9s ou diagnostiqu\u00e9s d'une infection par le SRAS-CoV-2","idno":"FRESH-PEF73838-fr","producers":[{"name":"JULIEN GAUTIER","affiliation":"UNICANCER GROUP"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73838-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73838"},{"agency":"FReSH","code":"FRESH-PEF73838"},{"agency":"NCT","code":"NCT04363632"}]},"title":"Analyse prospective de la morbi-mortalit\u00e9 des patients atteints de cancer en phase active de traitement suspect\u00e9s ou diagnostiqu\u00e9s d'une infection par le SRAS-CoV-2","alternate_title":"ONCOVID-19"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Souad;ASSAAD","PILabo":"Centre L\u00e9on B\u00e9rard","affiliationName":"CENTRE LEON BERARD","extlink":[{"title":"ORCID","uri":"0000-0002-5406-6385","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"779924133","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":"CENTRE LEON BERARD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"sponsor id"},{"title":"SIREN","uri":"779924133","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[],"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","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"L'objectif principal est de d\u00e9crire la mortalit\u00e9 des patients atteints de cancer sous traitement anticanc\u00e9reux actif ayant subi une proc\u00e9dure diagnostique (positive ou n\u00e9gative) pour une suspicion de COVID-19. Le crit\u00e8re d'\u00e9valuation principal sera le taux de mortalit\u00e9, d\u00e9fini comme la proportion de patients d\u00e9c\u00e9d\u00e9s 28 jours apr\u00e8s la date de la proc\u00e9dure diagnostique pour les deux cohortes de patients (positifs et n\u00e9gatifs).","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2020-12-31"}],"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\": \" Diagnostic confirm\u00e9 de tout type de tumeur solide ou h\u00e9matologique ; - Traitement anticanc\u00e9reux en cours (cytotoxique, th\u00e9rapie cibl\u00e9e, immunoth\u00e9rapie ou proc\u00e9dure loco-r\u00e9gionale, y compris radioth\u00e9rapie, chirurgie ou proc\u00e9dure de radiologie interventionnelle) au moment de l'inclusion ou au cours des 3 derniers mois pr\u00e9c\u00e9dant l'inclusion (derni\u00e8re administration de traitement ou derni\u00e8re proc\u00e9dure loco-r\u00e9gionale) ; - Patient avec suspicion de COVID-19 (sympt\u00f4mes cliniques de COVID-19 incluant fi\u00e8vre (>38\u00b0C) et\\\/ou sympt\u00f4mes des voies respiratoires), confirm\u00e9e ou non. Note 1 : Les patients doivent avoir subi des proc\u00e9dures de diagnostic : test de diagnostic (positif ou n\u00e9gatif) et\\\/ou imagerie thoracique. Note 2 : Les patients seront \u00e9ligibles ind\u00e9pendamment de la pr\u00e9sence d'une neutrop\u00e9nie (f\u00e9brile ou non). - Le patient et\\\/ou sa famille n'ont pas refus\u00e9 la collecte de donn\u00e9es apr\u00e8s avoir re\u00e7u des informations compl\u00e8tes (fiche d'information).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Monitoring \u00e0 distance']"}},"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":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1150"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"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":"09-12-2020","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":"Non","contributorName":"JULIEN GAUTIER","contributorAffiliation":"UNICANCER GROUP","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"Centres investigateurs","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France (Centres de lutte contre le cancer, h\u00f4pitaux universitaires et h\u00f4pitaux g\u00e9n\u00e9raux)"},"dataTypes":{"clinicalDataDetails":"Ant\u00e9c\u00e9dents de cancer, traitements actuels, diagnostic COVID-19 et statut vital","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"}