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Urine test may spare bladder cancer patients from frequent scopes

NCT ID NCT07511517

Diagnosis Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a urine test called BladMetrix to see if it can detect bladder cancer returning after surgery. 500 adults with non-muscle invasive bladder cancer will provide urine samples during routine follow-up visits over 2 years. The test's accuracy will be compared to standard cystoscopy (camera exam) and urine cytology. If it works well, it could reduce the need for invasive camera exams.

What this could mean

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

Active substance
BladMetrix urine test
What this could lead to
If successful, this urine test could reduce the need for frequent camera exams (cystoscopies) and allow more personalized follow-up schedules for people with bladder cancer.
What could go wrong
This is an observational study, not a treatment trial. The test is still being compared to standard methods, and it may not be accurate enough to replace cystoscopy. Results are early and need further validation.

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 500 people

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

Started

Oct 2019

Expected to finish

Jun 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 with non-muscle invasive bladder cancer (NMIBC) treated at participating urology departments in Norway form the study population. Participants are identified among patients undergoing transurethral resection of bladder tumor (TURB) for primary or recurrent NMIBC who have a positive BladMetrix urine test at baseline and are scheduled for guideline based outpatient surveillance at the participating hospitals. The population thus represents a real world NMIBC follow up cohort across all Norwegian health regions, including a spectrum of risk groups managed with standard cystoscopic surveillance, with or without intravesical therapy.

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: * Histologically verified non muscle invasive bladder cancer (NMIBC). * Positive pre-TURB BladMetrix test. * Planned outpatient follow-up at a participating hospital, with or without intravesical instillation therapy. * Age ≥ 18 years. * Able and willing to provide written informed consent and comply with study procedures, including repeated urine sampling. Exclusion Criteria: * NMIBC planned for radical treatment (for example, immediate cystectomy). * Judged by the investigator as unlikely to be able to adhere to the follow\_up schedule or provide required urine samples. * Known cancer of the upper urinary tract at inclusion. * Patients with permanent indwelling bladder catheter (for practical reasons in optimal urine sampling)

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Conditions

The condition(s) this trial relates to.

allergic disease bladder transitional cell carcinoma carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

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

Carcinoma Carcinoma, transitional cell, bladder Non-muscle invasive bladder neoplasms Urinary bladder neoplasms Urinary bladder noeplasms Urothelial carcinoma of the bladder

Contacts and locations

Locations

  • Akershus University Hospital (Ahus)

    Lørenskog, Norway

  • Haukeland University Hospital

    Bergen, Norway

  • Oslo University Hospital - Aker

    Oslo, Norway

  • St. Olavs Hospital - Trondheim University Hospital

    Trondheim, Norway

  • University Hospital of North Norway (UNN)

    Tromsø, Norway

  • Vestfold Hospital Trust (SiV)

    Tønsberg, Norway

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