Pee test could replace painful bladder scopes for cancer patients

NCT ID NCT07180212

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a simple urine test that looks for cancer DNA can help decide when patients with high-risk bladder cancer need a cystoscopy (a camera exam of the bladder). Cystoscopy is effective but uncomfortable and can cause infections. The goal is to safely reduce the number of these procedures without missing cancer recurrences. The trial will enroll 360 people and compare the urine test approach to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
urine tumor DNA (utDNA) test
What this could lead to
If successful, this approach could make bladder cancer monitoring more comfortable and efficient by using a simple urine test to decide when a cystoscopy is truly needed.
What could go wrong
This is an early-stage study with 360 participants, so results may not apply to all patients. The urine test might miss some cancers or lead to unnecessary procedures.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

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

Started

Sep 2025

Expected to finish

Nov 2027

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.

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: 1. Male or female participants aged 18 years or older. 2. Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk/very high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease. 3. Prior to enrollment, participants must have undergone either: A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery. Exclusion Criteria: 1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.

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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

    8 sites. 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

  • General Hospital of Tianjin Medical University

    RECRUITING

    Tianjin, China

  • Nanchang Second People's Hospital

    RECRUITING

    Nanchang, China

  • Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Haerbin, China

  • The Second Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, China

  • The second hospital of Tianjin Medical University

    RECRUITING

    Tianjin, 300000, China

  • Tianjin Hospital

    RECRUITING

    Tianjin, China

  • Xingtai People's Hospital

    RECRUITING

    Xingtai, Hebei, China

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