Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Usi… (NCT07307300) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
Germany1,475 participantsStarted 2026-03
Plain-language summary
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:
* Can the Xpert BC-D test accurately identify people at higher risk for bladder cancer?
* Can combining the test results with other clinical information improve risk assessment compared to standard evaluation methods?
Participants will:
* Have leftover urine from the routine initial evaluation tested with the Xpert® Bladder Cancer Detect assay
* Complete questionnaires about urinary symptoms using the modified IPSS and ICIQ-FLUT-S forms
* Attend a first visit for medical evaluation and cystoscopy
* Attend a follow-up visit 3 to 6 months later for additional testing and questionnaires
This 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.
The 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed consent form after being informed about the study
* Willing and able to follow the study requirements
* Non-visible blood in the urine, found within the past 6 months
* Age over 40 years
Exclusion Criteria:
* Previous diagnosis of bladder cancer
* Too much protein in the urine (shown by urine test)
* Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test)
* Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale
* Signs of kidney-related blood in the urine (found by special urine test)
* Bladder examination with a camera (cystoscopy) within the past 12 months
* Pregnancy
* Visible blood in the urine within the past year
* Previous surgery on the urinary tract
* Previous radiation treatment to the pelvic area
* Permanent tube or foreign body in the urinary tract (such as a catheter)
* Participation in another clinical study at the same time or within 30 days before this study
* Detained under legal or official authority
* Medical, psychological, or social problems that would make it hard to follow the study requirements
* Not able to understand the study information well enough to give consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validating results of a recent metanalysis (UroDetect II) achieving an overall sensitivity of the Xpert BC-D for UCas of >0.70 and a specificity of >0.65
Timeframe: From enrollment until completion of follow-up at 6 months