Pee test could replace needles for bladder cancer detection
NCT ID NCT07614594
First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study is testing whether a urine test can accurately detect urothelial carcinoma, a type of cancer that includes bladder cancer. Researchers are comparing the test results to standard tissue biopsies in 800 adults with blood in their urine and suspicious imaging findings. If the urine test proves reliable, it could offer a noninvasive, cheaper way to screen for these cancers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- urine DNA methylation test
- What this could lead to
- If successful, this could provide a simple, noninvasive way to detect bladder and related cancers early, reducing the need for invasive biopsies.
- What could go wrong
- This is an early observational study at a single center, so results may not apply to all patients. The test may not be accurate enough to replace standard diagnostic methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Dec 2030
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
Adult patients (≥18 years) presenting with gross or microscopic hematuria, who present with space-occupying lesions in the renal pelvis, ureter, or bladder by imaging (B-ultrasonography, CT, or MRI) and are scheduled for a diagnostic procedure to obtain tissue histopathological diagnosis.
- 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: Patients are eligible if they meet all of the following criteria: 1. Age ≥ 18 years. 2. Presence of gross or microscopic hematuria. 3. Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion. 4. Scheduled for surgery for tissue histopathological diagnosis. 5. Able to provide written informed consent. Exclusion Criteria 1. Inadequate urine sample (poor quality or insufficient volume). 2. Lack of final histopathological diagnosis.
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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
1 site. 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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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, 450003, China
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Other studies related to the condition(s) this trial covers.
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- Chemo gel delivered directly to kidney tumors: can it help when other options run out?
- Can tumor genes decide who keeps their bladder?
- Can heated saline during bladder surgery stop tumors from coming back?