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Urine test could spare bladder cancer patients from painful scopes

NCT ID NCT05796375

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 17, 2026 · Updated 5 times

Summary

This study tests whether a simple urine test (Bladder EpiCheck) can safely replace some of the invasive cystoscopy procedures used to monitor non-muscle invasive bladder cancer. About 240 adults with low-grade intermediate-risk bladder cancer will be followed to compare quality of life, discomfort, anxiety, and cancer outcomes between those who get standard cystoscopies and those who get urine tests instead. The goal is to see if monitoring can be made less burdensome without missing cancer recurrences.

What this could mean

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

Active substance
Bladder EpiCheck urine test
What this could lead to
If successful, this could make bladder cancer monitoring less invasive and more comfortable, reducing the need for frequent cystoscopies.
What could go wrong
This is a Phase 2 trial with 240 participants, so results are preliminary. The urine test may not catch all recurrences, and some cystoscopies may still be needed.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

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

Started

Nov 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

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. Aged 18 years or older 2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following: * multifocal low grade non-invasive urothelial carcinoma of any size * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size * recurrent low grade non-invasive urothelial carcinoma 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection 5. Ability to consent in English or Spanish Exclusion Criteria: 1. History of total cystectomy of the bladder. 2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit). 3. History of muscle-invasive bladder tumor. 4. Pregnancy or lactation. 5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion) 6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture). 7. Inability to provide a voided urine sample.

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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.

  1. The places running it

    8 sites. 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

  • Bay Pines VA Healthcare System

    RECRUITING

    Bay Pines, Florida, 33744, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • James A. Haley Veterans' Hospital

    WITHDRAWN

    Tampa, Florida, 33612, United States

  • Medical University of South Carolina

    ACTIVE_NOT_RECRUITING

    Charleston, South Carolina, 29425, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • VA Boston Jamaica Plains Campus

    RECRUITING

    West Roxbury, Massachusetts, 02132, United States

  • VA St.Louis Healthcare System

    RECRUITING

    St Louis, Missouri, 63016, United States

  • West Haven VA Medical Center

    RECRUITING

    West Haven, Connecticut, 06516, United States

  • White River Junction Veterans Healthcare System

    RECRUITING

    White River Junction, Vermont, 05009, United States

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