[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578964":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":116,"collaborators":10,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":10,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":10,"enrollmentInfo":127,"targetDuration":10,"studyType":130,"phases":10,"briefSummary":131,"conditions":132,"keywords":138,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Nucleix Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma",null,"Adult participants aged ≥ 45 years presenting with haematuria in the past 6 months, scheduled to undergo haematuria workup, including cystoscopy, for suspicion of urothelial carcinoma.",[13],"Diagnostic Test: Bladder EpiCheck",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Bladder EpiCheck","The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.",[9],[21],{"name":22,"affiliation":23,"role":24},"Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS","Western General Hospital, Edinburgh","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Vered Yayon","CONTACT","+972-8-9161616","vered.y@nucleix.com",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},"Admin.","info@nucleix.com",[35,57,72,88,103],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"NHS Fife","RECRUITING","Dunfermline","Fife","KY12 OSU","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-3.45887,56.07156,{"lat":47,"lon":46},[50,55],{"name":51,"role":28,"phone":52,"phoneExt":53,"email":54},"Keith Boath","01383 623623","28694","fife.rdgenericresearchteam@nhs.scot",{"name":56,"role":24,"phone":10,"phoneExt":10,"email":10},"Feras Al Jaafari, Dr.",{"facility":58,"status":37,"city":59,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Addenbrooke's Hospital","Cambridge",{"type":44,"coordinates":61},[62,63],0.11667,52.2,{"lat":63,"lon":62},[66,70],{"name":67,"role":28,"phone":68,"phoneExt":10,"email":69},"Kelly Leonard","+44 (0)1223 348442","kelly.leonard3@nhs.net",{"name":71,"role":24,"phone":10,"phoneExt":10,"email":10},"Niyati Lobo, Dr.",{"facility":73,"status":37,"city":74,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"NHS Lothian","Edinburgh",{"type":44,"coordinates":76},[77,78],-3.19648,55.95206,{"lat":78,"lon":77},[81,86],{"name":82,"role":28,"phone":83,"phoneExt":84,"email":85},"Simmi George","(+44)0131 537 3269","33269","simmi.george@nhs.scot",{"name":87,"role":24,"phone":10,"phoneExt":10,"email":10},"Param Mariappan, Professor",{"facility":89,"status":37,"city":90,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Guy's and St Thomas","London",{"type":44,"coordinates":92},[93,94],-0.12574,51.50853,{"lat":94,"lon":93},[97,101],{"name":98,"role":28,"phone":99,"phoneExt":10,"email":100},"Grainne Cullen","(44) 020 7188 5678","grainne.cullen@nhs.net",{"name":102,"role":24,"phone":10,"phoneExt":10,"email":10},"Elsie Mensah, Dr.",{"facility":104,"status":37,"city":105,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Frimley","Surrey Quays",{"type":44,"coordinates":107},[108,109],-0.04802,51.49353,{"lat":109,"lon":108},[112],{"name":113,"role":28,"phone":114,"phoneExt":10,"email":115},"Alexandra Edwards","(+44) 0300 613 6779","alexandra.edwards3@nhs.net",{"type":117,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100578964","bladder-epicheck-european-haematuria-study-100578964",false,"NCT06818136","Bladder EpiCheck European Haematuria Study","Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria","Inclusion Criteria:\n\n1. Participants aged 45 years or older\n2. Participants who are willing and able to provide written informed consent and adhere to study procedures\n3. Participants presenting with visible and\u002For non-visible haematuria within 6 months prior to study enrollment\n4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment\n5. Participants who are able to produce at least 10 ml of voided urine\n\nExclusion Criteria:\n\n1. Participants with history of urothelial cancer in the bladder and\u002For upper urinary tract\n2. Participants who had prior cystoscopy for haematuria within the past 2 years\n3. Participants previously enrolled in this study\n4. Participants treated for prostate cancer within the last 12 months\n5. Participants treated for kidney cancer within the last 12 months\n6. Participants with untreated urinary tract infection\n7. Participants with symptomatic urinary tract stones (e.g. flank pain)\n8. Participants on dialysis for end stage renal failure\n9. Participants with a long term urinary catheter\n10. Pregnancy (self-reported)\n11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway","ALL","45 Years",{"count":128,"type":129},800,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.\n\nParticipants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.",[133,134,135,136,137],"Hematuria","Cystoscopy","Urothelial Carcinoma Bladder","Urothelial Carcinoma of the Renal Pelvis and Ureter","Urothelial Carcinoma of the Urinary Bladder",[139,140,141],"urine test","methylation","primary detection","2026-01-21",{"date":144,"type":145},"2026-01-22","ACTUAL",{"date":147,"type":145},"2025-06-20",{"date":149,"type":129},"2026-12",{"name":5,"class":6},5]