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Could a simple urine test spare bladder cancer patients from chemotherapy?

NCT ID NCT07749924

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial asks whether some people with intermediate-risk bladder cancer can safely skip chemotherapy after having their tumor removed. Doctors will use a urine test before surgery to find patients whose tumors are unlikely to shed detectable signals. These patients will then be randomly assigned to either standard chemotherapy placed into the bladder or active surveillance with regular check-ups. The goal is to see if active surveillance keeps the cancer from coming back just as well as chemotherapy, without the extra treatment burden.

What this could mean

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

Active substance
Active surveillance (no drug) versus adjuvant intravesical chemotherapy (gemcitabine or mitomycin C)
What this could lead to
If active surveillance proves as effective as chemotherapy, many patients could avoid the discomfort and side effects of bladder instillations without raising their risk of recurrence.
What could go wrong
This is an early-stage trial, and skipping chemotherapy might increase the chance of the cancer coming back in some patients. The urine test used to select patients is not perfect, so some may still benefit from chemo.

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 670 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2032

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. Age ≥18 years. 2. Histologically confirmed urothelial carcinoma of the urinary bladder, including tumors with divergent differentiation, provided that the urothelial carcinoma component accounts for \>50% of the tumor 3. Non-muscle-invasive bladder cancer classified as intermediate-risk according to the 2021 European Association of Urology (EAU) NMIBC prognostic risk-group definition. Intermediate-risk disease is defined as NMIBC without concomitant carcinoma in situ that does not meet the criteria for the EAU low-, high-, or very-high-risk groups. 4. Complete transurethral resection of all visible bladder tumors performed within 6 weeks before randomization, with no macroscopically visible residual disease. 5. Negative multi-urinary liquid biopsy results after complete TURBT and before randomization. 6. Eastern Cooperative Oncology Group performance status of 0-2. 7. Adequate clinical condition to undergo protocol-specified intravesical therapy, cystoscopic surveillance, and study-related procedures. 8. Ability to understand the study requirements and provide written informed consent. Exclusion Criteria: 1. EAU low-risk, high-risk, or very-high-risk NMIBC. 2. Any current or previous concomitant carcinoma in situ associated with the qualifying tumor episode. 3. Muscle-invasive bladder cancer, locally advanced urothelial carcinoma, lymph-node involvement, or metastatic urothelial carcinoma. Incomplete TURBT, macroscopically visible residual tumor, or inability to achieve complete endoscopic resection before randomization. 4. Urothelial carcinoma involving the prostatic stroma or prostatic ducts, or carcinoma in situ of the prostatic urethra. 5. Severe lower urinary tract dysfunction, bladder capacity considered insufficient for intravesical treatment, or another clinically significant urological condition that may interfere with treatment or outcome assessment. 6. Another active malignancy requiring systemic treatment or likely to interfere with the assessment of study endpoints, except adequately treated non-melanoma skin cancer, localized prostate cancer under surveillance, or another malignancy with a negligible risk of recurrence, as determined by the investigator. 7. Pregnant or breastfeeding women. 8. Any serious uncontrolled medical, psychiatric, or social condition that, in the investigator's judgment, would compromise participant safety, protocol adherence, or interpretation of study results.

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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

    5 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

  • Daqing Oil General Hopital

    Daqing, China

  • General Hospital of Tianjin Medical University

    Tianjin, China

  • Nanchang Second People's Hospital

    Nanchang, China

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300000, China

  • Tianjin Hospital

    Tianjin, China

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