[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Christian Bolenz\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},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.",[25],"Hematuria",[27,28,29,30,31,32,33],"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":37,"type":38},"2025-12-29","ACTUAL",{"date":40,"type":21},"2026-03",{"date":42,"type":21},"2028-06",{"name":44,"class":45},"Christian Bolenz","OTHER",""]