Urine test could spot bladder cancer without a scope
NCT ID NCT04943380
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a urine test called Cxbladder can accurately detect bladder cancer in 682 people who had blood in their urine. The test's results were compared to the standard method, a camera exam of the bladder (cystoscopy). The goal was to see if the urine test could reliably identify who has cancer and who does not, potentially reducing the need for invasive procedures.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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682 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Jan 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will be conducted with all hematuria patients who present to an outpatient clinic to undergo clinical assessment including cystoscopy and who fulfil study requirements. Consented eligible patients will attend their scheduled clinic visit and undergo all standard tests as clinically indicated.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma. * Able to provide a voided urine sample of the required minimum volume * Able to give written consent * Able and willing to comply with study requirements * Aged 18 years or older Exclusion Criteria: * Prior history of bladder malignancy, prostate or renal cell carcinoma * Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection * Previous alkylating based chemotherapy * Known Pregnancy.
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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.
Contacts and locations
Locations
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Bay Pines Veterans Affairs
Bay Pines, Florida, 33744-8200, United States
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James A Haley Veterans' Hospital
Tampa, Florida, 33612-4745, United States
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James J. Peters VAMC
New York, New York, 10468-3904, United States
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Medical University of South Carolina
Charleston, South Carolina, 29401, United States
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Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
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NWIHCS-Omaha VA Medical Center
Omaha, Nebraska, 68105, United States
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Oklahoma City VA Hospital
Oklahoma City, Oklahoma, 73104, United States
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South Florida Veterans Affairs
Miami, Florida, 33125, United States
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Veterans Medical Research Foundation
San Diego, California, 92161, United States
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White River Junction VAMC
White River Junction, Vermont, 05009, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bladder-Sparing hope: cystoscopy tested to spot Cancer-Free bladders before surgery
- Can intensified chemotherapy before surgery clear bladder tumors?
- Chemo combo tested as backup for bladder cancer that outsmarts First-Line therapy
- Chemo gel delivered directly to kidney tumors: can it help when other options run out?
- Can tumor genes decide who keeps their bladder?
- New antibody aims to preserve immune checkpoint while fighting cancer