{"doc_desc":{"title":"\u00c9valuation d'une technologie ddPCR pour la d\u00e9tection du SARS-CoV-2 \u00e0 partir de diff\u00e9rents types d'\u00e9chantillons chez des patients atteints de cancer avec suspicion de COVID-19 (symptomatique)","idno":"FRESH-PEF73849-fr","producers":[{"name":"Ellen BLANC","affiliation":"UNICANCER GROUP"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73849-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73849"},{"agency":"FReSH","code":"FRESH-PEF73849"},{"agency":"NCT","code":"NCT04510454"}]},"title":"\u00c9valuation d'une technologie ddPCR pour la d\u00e9tection du SARS-CoV-2 \u00e0 partir de diff\u00e9rents types d'\u00e9chantillons chez des patients atteints de cancer avec suspicion de COVID-19 (symptomatique)","alternate_title":"ONCOVID-21"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"B\u00e9n\u00e9dicte;MASTROIANNI","firstname":"B\u00e9n\u00e9dicte","lastname":"MASTROIANNI","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id"},{"title":"SIREN","uri":"779924133","role":"organisation id"}],"email":"","affiliationName":"CENTRE LEON BERARD","PILabo":"CENTRE LEON BERARD \/ Medical Oncology Department","isContact":false}],"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":""}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"SARS-CoV-2"},{"keyword":"cancer"},{"keyword":"ddPCR"},{"keyword":"RT-qPCR"},{"keyword":"s\u00e9rologie"}],"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":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"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":"D\u00e9terminer la capacit\u00e9 du ddPCR \u00e0 d\u00e9tecter le SARS-CoV-2 dans des \u00e9chantillons nasopharyng\u00e9s de patients symptomatiques suspect\u00e9s d'infection \u00e0 la COVID-19, en utilisant un test s\u00e9rologique IgG (EUROIMMUN Anti-SARS-CoV-2 ELISA IgG) comme r\u00e9f\u00e9rence absolue\/\u00e9talon-or (test s\u00e9rologique commercial valid\u00e9 par la FDA).","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [],\n    \"level_age_clusion_I\": [],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"1. \u00c2ge \u2265 18 ans le jour de la signature du consentement \u00e9clair\u00e9. 2. Diagnostic confirm\u00e9 de tout type de tumeur solide ou h\u00e9matologique. 3. Traitement anticanc\u00e9reux en cours 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). 4. Suspicion d'infection par COVID-19. Les patients ne doivent pas avoir subi de test diagnostique et\\\/ou d'imagerie thoracique avant l'inclusion. * Au moins un des sympt\u00f4mes cliniques suivants : fi\u00e8vre (>38\u00b0C), toux s\u00e8che, fatigue, atteinte pulmonaire (infection respiratoire f\u00e9brile ou difficult\u00e9s respiratoires), pharyngalgies, c\u00e9phal\u00e9es, myalgies, sympt\u00f4mes gastro-intestinaux incluant douleurs abdominales et diarrh\u00e9e, anosmie et agueusie, signes radiologiques de pneumonie tels que d\u00e9crits par Shi et al. 5. Couvert par une assurance m\u00e9dicale\\\/de sant\u00e9. 6. Formulaire de consentement \u00e9clair\u00e9 sign\u00e9 et dat\u00e9.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[],"target_sample_size":"< 500 individus","response_rate":""},"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":"15-12-2020","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"ant\u00e9c\u00e9dents m\u00e9dicaux, ant\u00e9c\u00e9dents de cancer, examen clinique, traitements anticanc\u00e9reux, sympt\u00f4mes, r\u00e9sultats de la ddPCR, de la RT-qPCR et de la s\u00e9rologie","biologicalDataDetails":"H\u00e9matologie, biochimie sanguine","isDataInBiobank":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}