Pee test may spare thousands from painful bladder scopes

NCT ID NCT05889195

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Recruiting now This study
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By invitation only
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Paused for now. It may or may not start again.
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Completed
The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, non-invasive urine test called Cxbladder Triage-Plus to see if it can accurately detect bladder cancer in people who have microscopic blood in their urine. Currently, these patients often need a cystoscopy, an invasive procedure where a camera is inserted into the bladder, which can be painful and cause anxiety. The study aims to validate the test's performance in 1,000 participants, potentially offering a simpler and safer way to rule out cancer.

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 1,000 people

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

Started

Nov 2023

Expected to finish

Jun 2026

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

This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in the urine) from US sites. This study will be conducted on subjects with microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma.

Ages

18 to 89 years

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. Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria: EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria. 2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered. 3. Able to give informed, written consent. 4. Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service). 5. Aged 18 years or older. Footnotes: 1. For the microscopic hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder. ii) Patients who are considered high risk by the AUA 2020 guidelines. 2. For gross hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder Exclusion Criteria: 1. Prior history of bladder malignancy. 2. Reported Cxbladder results within the last six months. 3. Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC. 4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch). 5. Subjects aged 89 years of age or older. 6. Subjects with a history of pelvic radiation. 7. Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks. 8. Subjects with renal failure on dialysis. 9. History of schistosomiasis. 10. Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.

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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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • AccuMed Research Associates

    RECRUITING

    Garden City, New York, 11530, United States

  • Durham VA Health Care System

    RECRUITING

    Durham, North Carolina, 27705, United States

  • The Urology Place

    RECRUITING

    San Antonio, Texas, 78240, United States

    Contact Email: •••••@•••••

  • Tri Valley Urology Medical Group

    RECRUITING

    Murrieta, California, 92562, United States

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