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Urine test may spare bladder cancer patients from unnecessary second surgery

NCT ID NCT07130578

Diagnosis Sponsor: Tianjin Medical University Second Hospital Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)

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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a simple urine test can detect leftover cancer after initial surgery for high-risk bladder cancer. The goal is to help doctors decide who truly needs a second surgery, avoiding unnecessary procedures and their risks. About 60 adults with high-risk non-muscle-invasive bladder cancer will provide urine samples before a planned second surgery, and the test results will be compared to standard tissue analysis.

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 60 people

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

Started

Sep 2025

Expected to finish

May 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.

Who is studied

Adults (≥18 years) with histologically confirmed high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone initial transurethral resection of bladder tumor (TURBT) and are scheduled for second TURBT. Eligible tumors are urothelial carcinoma or bladder tumors with urothelial carcinoma as the predominant component (\>50%), with no evidence of muscle-invasive or metastatic disease.

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: Participants must meet all of the following criteria to be eligible for the study: 1. Male or female, aged 18 years or older. 2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease. 3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\>50%). 4. At least one of the following conditions: 1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection. 2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \[CIS\]). 3. T1 stage tumor. 5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT. 6. Willingness to provide tumor tissue samples for pathological examination. 7. Willingness to undergo genetic testing required for the trial. 8. Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up. Exclusion Criteria: 1. Contraindications to transurethral resection of bladder tumor (TURBT). 2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).

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Conditions

The condition(s) this trial relates to.

Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Liquid biopsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 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, 300000, China

  • The second hospital of Tianjin Medical University

    RECRUITING

    Tianjin, China

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