{"doc_desc":{"title":"Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic)","idno":"FRESH-PEF73849-en","producers":[{"name":"Ellen BLANC","affiliation":"UNICANCER GROUP"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73849-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73849"},{"agency":"FReSH","code":"FRESH-PEF73849"},{"agency":"NCT","code":"NCT04510454"}]},"title":"Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic)","alternate_title":"ONCOVID-21"},"study_authorization":{"agency":[]},"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":"Epidemiology France Portal (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":"SARSCOV2"},{"keyword":"CANCER"},{"keyword":"ddPCR"},{"keyword":"RT-qPCR"},{"keyword":"SEROLOGICAL ASSAYS"}],"topics":[{"topic":"Oncology","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":"Infectious disease medicine","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":"Neoplasms","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":"To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA IgG) as gold\/reference standard (FDA validated commercial serologic test). The primary endpoint will be the sensibility of the ddPCR assay for SARS-CoV-2 detection based on nasopharyngeal samples.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [],\n    \"level_age_clusion_I\": [],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"1. Age \u2265 18 years on the day of signing informed consent. 2. Confirmed diagnosis of any type of solid or hematologic tumor. 3. Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) 4. Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and\\\/or chest imaging before inclusion. * At least one of the following clinical symptoms: fever (>38\u00b0C), dry cough, fatigue, pulmonary involvement (febrile respiratory infection or respiratory difficulties), pharyngalgia, headaches, myalgia, gastrointestinal symptoms including abdominal pain and diarrhea, anosmia and agueusia, radiological signs of pneumonia as described by Shi et al. 5. Covered by a medical\\\/health insurance. 6. Signed and dated informed consent form.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","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\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"","sources":[],"target_sample_size":"< 500 individuals","response_rate":""},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","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":["Private non-profit"],"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":"MEDICAL HISTORY, CANCER HISTORY, CLINICAL EXAMINATION, ANTI-CANCER TREATMENTS, SYMPTOMS, RESULTS OF ddPCR, RT-qPCR AND SEROLOGY","biologicalDataDetails":"HEMATOLOGY, BLOOD CHEMISTRY","isDataInBiobank":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}