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Pee test could replace needles for bladder cancer detection

NCT ID NCT07614594

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

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