[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581359":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":16,"studyPopulation":17,"armGroups":13,"interventions":13,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":43,"collaborators":13,"id":45,"slug":13,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":13,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":13,"enrollmentInfo":53,"targetDuration":13,"studyType":56,"phases":13,"briefSummary":57,"conditions":58,"keywords":13,"overallStatus":27,"whyStopped":13,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Royal Cornwall Hospitals Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Primary endpoints","to measure the accuracy of the Thyroid print test against the surgical pathology report.","Samples taken at Baseline",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":6,"maskingInfo":13},"CASE_ONLY","This is a multicenter, non-interventional (observational), prospective, post-market study, matching the Idylla™ ThyroidPrint® RUO Assay result to the gold standard of surgical pathology.\n\nThe study population is defined as cases where the thyroid nodule has been reported as indeterminate.\n\nPrimary endpoints are the calculation of the sensitivity, specificity, and the negative and positive predictive values of the Idylla™ ThyroidPrint® RUO Assay for indeterminate thyroid nodules.\n\nSecondary endpoint: to assess the failure rate of Idylla™ ThyroidPrint® RUO Assay, including errors and invalids; describe the nature of false negative and false positive cases.","The study population is defined as cases where the thyroid nodule has been reported as indeterminate.",[19],{"name":20,"role":21,"phone":22,"phoneExt":13,"email":23},"Verity Teague Research Sponsorship Facilitator","CONTACT","0044 1872256429","rcht.sponsor@nhs.net",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Royal Cornwall Hospital","RECRUITING","Truro","Cornwall","TR1 3HD","United Kingdom","UK",{"type":34,"coordinates":35},"Point",[36,37],-5.05436,50.26526,{"lat":37,"lon":36},[40],{"name":41,"role":21,"phone":42,"phoneExt":13,"email":23},"Verity Teague","01872256429",{"type":44,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100581359",false,"NCT06849284","To Perform a Post-market Study of the Performance of the Idylla ThyroidPrint Assay Using Clinical Samples in Predicting the Nature of Indeterminate Thyroid Nodules (ITNs) Across Multiple Centers.","Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study","Inclusion Criteria:\n\n* Thyroid nodule ≥1.0 cm\n* With indeterminate cytology\n* Surgery due to be performed\n\nExclusion Criteria:\n\n* Specimens which fail to meet the inclusion criteria.\n* FNA fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions.\n* RNA extracts.\n* Patients with ultrasound evidence of malignant cervical adenopathy","ALL","18 Years",{"count":54,"type":55},100,"ESTIMATED","OBSERVATIONAL","To perform a post-market study of the performance of the Idylla™ ThyroidPrint® Assay using clinical samples in predicting the nature of indeterminate thyroid nodules (ITNs) across multiple centers.",[59],"Thyroid Cancer","2025-05-29",{"date":62,"type":63},"2025-06-04","ACTUAL",{"date":65,"type":63},"2024-12-16",{"date":67,"type":55},"2025-06-30",{"name":5,"class":6},1]