Simple urine test could spot bladder cancer early, avoiding unnecessary scopes
NCT ID NCT03193541
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new urine test that looks for specific proteins to detect bladder cancer in people who have microscopic blood in their urine (not visible to the naked eye). The goal is to see if this simple, non-invasive test can accurately identify cancer, potentially reducing the need for invasive procedures like cystoscopy. About 900 adults with microscopic hematuria will provide urine samples, and the test results will be compared to standard cystoscopy findings.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 900 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2016
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults, age 18 and older who have documented microscopic hematuria within the past 3 months who are referred for cystoscopy and are willing to participate
- Ages
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18 to 90 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older * Have documented or reported microscopic hematuria within 3 month of study enrollment * Willing and able to give written informed consent Exclusion Criteria (participants must not): * Have history of BCa * History of previous cancer (excluding basal and squamous cell skin cancer) * Have a known active urinary tract infection or urinary retention * Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) * Have ureteral stents, nephrostomy tubes or bowel interposition * Have recent genitourinary instrumentation (within 10 days prior to signing consent) * Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Hoag Memorial Hospital Presbyterian
RECRUITINGNewport Beach, California, 92663, United States
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Nara Medical University
RECRUITINGNara, Japan
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Nara Prefecture Seiwa Medical Center
RECRUITINGNara, Nara, 636-0802, Japan
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UCLA Medical Center
RECRUITINGLos Angeles, California, 90095, United States
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UT Southwestern Medical Center at Dallas
RECRUITINGDallas, Texas, 75390, United States
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University of Rochester Medical Center
RECRUITINGRochester, New York, 14620, United States
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VA Long Beach Healthcare System
RECRUITINGLong Beach, California, 90822, United States
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Other studies related to the condition(s) this trial covers.
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- Can a radioactive drug seek out and attack solid tumors?