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Simple DNA test could predict bladder cancer recurrence

NCT ID NCT07424560

Diagnosis Sponsor: Zhilong Dong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is developing a new DNA test that looks for key genetic changes in bladder cancer tumors. Researchers will collect tumor samples from 400 patients to build and validate the test. The goal is to create a cost-effective tool that helps doctors predict which patients are at higher risk of recurrence and tailor treatments accordingly.

What this could mean

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

Active substance
Multiplex mutation detection system (nucleic acid mass spectrometry)
What this could lead to
If successful, this could lead to a simple, affordable DNA test that helps doctors predict bladder cancer recurrence and choose the best treatment for each patient.
What could go wrong
This is an early-stage study focused on developing and validating the test, not yet proving it improves patient outcomes. The test may not be accurate enough for routine use.

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 400 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

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

This study will include adult patients aged 18 years or older with a histologically confirmed diagnosis of urothelial carcinoma of the bladder, including both non-muscle invasive bladder cancer and muscle invasive bladder cancer. Eligible participants must have sufficient fresh frozen tumor tissue samples available for DNA extraction and mutation analysis. Exclusion criteria include inadequate tumor tissue DNA quality for mutation analysis, pregnancy or breastfeeding, and serious uncontrolled intercurrent illnesses that may interfere with study participation. The study population will be representative of bladder cancer patients receiving standard clinical management, focusing on genetic mutation profiling for improved risk stratification and treatment prediction.

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. Histologically confirmed diagnosis of urothelial carcinoma of the bladder (any stage, including non-muscle invasive and muscle invasive). \- 2. Availability of sufficient tumor tissue specimen (fresh frozen) for DNA extraction and mutation analysis. \- 3. Age ≥ 18 years at time of diagnosis. Exclusion Criteria: 1. History of other malignant tumors within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. \- 2. Inadequate quality or quantity of tumor tissue DNA for mutation panel analysis (e.g., severe DNA degradation, insufficient DNA yield). \- 3. Pregnancy or breastfeeding. \- 4. Serious uncontrolled intercurrent illness that would interfere with study follow-up or compliance, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma urinary bladder cancer urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Adjuvant therapy for bladder cancer Bladder cancer Bladder cancer recurrence Progression of bladder cancer

How to take part

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

  1. The places running it

    1 site. 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

  • The Second Hospital of Lanzhou University

    RECRUITING

    Lanzhou, Gansu, 730030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.