Could a simple urine test spare bladder cancer patients from chemotherapy?
NCT ID NCT07749924
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 670 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2032
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.
- 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: 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.
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The places running it
5 sites. 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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Daqing Oil General Hopital
Daqing, China
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General Hospital of Tianjin Medical University
Tianjin, China
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Nanchang Second People's Hospital
Nanchang, China
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The Second Hospital of Tianjin Medical University
Tianjin, 300000, China
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Tianjin Hospital
Tianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Can a radioactive antibody light up hidden tumors on PET scans?