[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616568":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":32,"collaborators":36,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":7,"enrollmentInfo":53,"targetDuration":7,"studyType":56,"phases":7,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":68,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University Hospital Ulm","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Christian Bolenz, Univ. Prof. Dr. med.","CONTACT","+49 731 500 58000","PM.ZKS@uniklinik-ulm.de",[15],{"facility":16,"status":7,"city":17,"state":7,"zip":18,"country":19,"countryCode":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":27},"Urology and Pediatric Urology University Hospital Ulm","Ulm","89081","Germany","DE",{"type":22,"coordinates":23},"Point",[24,25],9.99155,48.39841,{"lat":25,"lon":24},[28,30],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":29},"studien.urologie@uniklinik-ulm.de",{"name":10,"role":31,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Christian Bolenz","Prof. Dr. med. Christian Bolenz",[37,40],{"name":38,"class":39},"Cepheid","INDUSTRY",{"name":41,"class":42},"Prof. Dr. med. Bernd Schmitz-Dräger","UNKNOWN","100616568","study-on-risk-assessment-for-patients-with-microscopic-hematuria-non-visible-blood-in-urine-using-a-urine-marker-test-100616568",false,"NCT07307300","Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test","Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)","UroDetect III","Inclusion Criteria:\n\n* Signed consent form after being informed about the study\n* Willing and able to follow the study requirements\n* Non-visible blood in the urine, found within the past 6 months\n* Age over 40 years\n\nExclusion Criteria:\n\n* Previous diagnosis of bladder cancer\n* Too much protein in the urine (shown by urine test)\n* Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test)\n* Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale\n* Signs of kidney-related blood in the urine (found by special urine test)\n* Bladder examination with a camera (cystoscopy) within the past 12 months\n* Pregnancy\n* Visible blood in the urine within the past year\n* Previous surgery on the urinary tract\n* Previous radiation treatment to the pelvic area\n* Permanent tube or foreign body in the urinary tract (such as a catheter)\n* Participation in another clinical study at the same time or within 30 days before this study\n* Detained under legal or official authority\n* Medical, psychological, or social problems that would make it hard to follow the study requirements\n* Not able to understand the study information well enough to give consent","ALL","40 Years",{"count":54,"type":55},1475,"ESTIMATED","OBSERVATIONAL","The goal of this clinical study is to learn how well a urine test called Xpert® Bladder Cancer Detect (Xpert BC-D) can help doctors assess the risk of bladder cancer in people with non-visible blood in their urine (microscopic hematuria). The main questions it aims to answer are:\n\n* Can the Xpert BC-D test accurately identify people at higher risk for bladder cancer?\n* Can combining the test results with other clinical information improve risk assessment compared to standard evaluation methods?\n\nParticipants will:\n\n* Have leftover urine from the routine initial evaluation tested with the Xpert® Bladder Cancer Detect assay\n* Complete questionnaires about urinary symptoms using the modified IPSS and ICIQ-FLUT-S forms\n* Attend a first visit for medical evaluation and cystoscopy\n* Attend a follow-up visit 3 to 6 months later for additional testing and questionnaires\n\nThis study includes adults over 40 years of age who have had microscopic hematuria detected within the past six months. People with a history of bladder cancer, urinary tract surgery, or certain other medical conditions, as well as individuals who are currently pregnant, cannot participate.\n\nThe study will be conducted at 20-24 sites in Germany and Austria and will last approximately 27 months, with each participant involved for about 6 months. The results of this study may help doctors better decide which patients need further invasive testing, potentially reducing unnecessary procedures.",[59],"Hematuria",[61,62,63,64,65,66,67],"Non-visible hematuria","Microscopic hematuria","Bladder cancer risk","Xpert Bladder Cancer Detect","Risk stratification","Diagnostic assessment","Urinary marker","NOT_YET_RECRUITING","2025-12-14",{"date":71,"type":72},"2025-12-29","ACTUAL",{"date":74,"type":55},"2026-03",{"date":76,"type":55},"2028-06",{"name":34,"class":6},1]