Pee test could replace painful bladder scopes for cancer patients
NCT ID NCT07180212
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
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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 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2027
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. 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.
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The places running it
8 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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General Hospital of Tianjin Medical University
RECRUITINGTianjin, China
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Nanchang Second People's Hospital
RECRUITINGNanchang, China
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Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University
RECRUITINGGuangzhou, China
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The First Affiliated Hospital of Harbin Medical University
RECRUITINGHaerbin, China
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The Second Affiliated Hospital of Kunming Medical University
RECRUITINGKunming, China
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The second hospital of Tianjin Medical University
RECRUITINGTianjin, 300000, China
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Tianjin Hospital
RECRUITINGTianjin, China
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Xingtai People's Hospital
RECRUITINGXingtai, Hebei, 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 radioactive antibody light up hidden tumors on PET scans?
- Can a radioactive drug seek out and attack solid tumors?