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Pee test could replace scope for bladder cancer checks

NCT ID NCT05080998

Diagnosis Sponsor: Pacific Edge Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study is testing a simple urine test called CxBladder to see if it can accurately detect when bladder cancer comes back. Currently, patients need a camera inserted into the bladder (cystoscopy) for monitoring, which is uncomfortable and costly. The study will collect urine samples from 450 people with a history of bladder cancer and compare the test results to standard cystoscopy findings.

What this could mean

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

Active substance
CxBladder Monitor/Monitor+ (urinary biomarker test)
What this could lead to
If successful, this urine test could replace some cystoscopies, making bladder cancer monitoring less invasive and more convenient.
What could go wrong
This is an observational study, not a treatment trial. The test may not be accurate enough to replace cystoscopy, and results may not apply to all patients.

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 450 people

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

Started

Jun 2022

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will recruit low-, intermediate-, and high-risk surveillance subjects (defined as per AUA/SUP Guidelines 2016, amendment 2020), previously diagnosed with urothelial carcinoma.

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. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years. 2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit. 3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible). 4. Able to give written informed consent 5. Able and willing to comply with study requirements 6. Aged 18 years or older Exclusion Criteria: 1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits 2. Previous muscle invasive bladder tumour (pT2 or greater) 3. Known pregnancy Deferral Criteria 1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed. 2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved. 3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma Recurrence urothelial carcinoma

As listed by the trial registrant

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

Urothelial bladder cancer

Contacts and locations

Locations

  • James A. Haley Veteran's Hospital

    Tampa, Florida, 33612, United States

  • Miami VA Healthcare System

    Miami, Florida, 33125, United States

  • Monash Health - Moorabbin Hospital

    Clayton, Victoria, 3165, Australia

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Washington School of Medicine

    Seattle, Washington, 98195, United States

  • White River Junction Veterans Affair Medical Center

    White River Junction, Vermont, 05009, United States

More trials for these conditions

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