Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
This study is looking at a urine test called Cxbladder Triage Plus to see if it can help doctors decide if patients with blood in their urine (hematuria) need an invasive procedure called a cystoscopy. A cystoscopy involves inserting a thin camera into the bladder. Currently, many patients with microscopic hematuria (blood not visible to the naked eye) undergo cystoscopy, even though their risk of bladder cancer (urothelial carcinoma) is low. The study aims to see if the Cxbladder Triage Plus test, which looks for specific markers in your urine, can accurately identify who truly needs a cystoscopy. This study is for veterans aged 18 to 89 who have been referred to a urologist for hematuria and are scheduled for a cystoscopy or had one recently. The study plans to enroll 1000 participants and is currently unclear on its recruitment status.
- Study design
- This is an observational study involving up to 1000 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will undergo all standard medical tests as usual and provide one additional urine sample for the Cxbladder test either at home or in the clinic.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your urine sample will be collected within 90 days before your scheduled cystoscopy or within 10 weeks after it.
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Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Tony Lough, PhD · STUDY_CHAIR · Pacific Edge (Australia) Pty Ltd
Who to contact
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What this trial measures
- To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of hematuria.Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
Cxbladder Triage-Plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.