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Simple urine test could replace painful scope for bladder cancer detection

NCT ID NCT03193528

Diagnosis Sponsor: Cedars-Sinai Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a new urine test that looks for specific markers of bladder cancer. The goal is to see if this simple, non-invasive test can accurately detect bladder cancer in 450 people who have blood in their urine, potentially reducing the need for a more invasive camera test called cystoscopy.

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

450 people

The number who actually took part.

Started

Dec 2016

Expected to finish

Jul 2026

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, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate

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: * Age 18 years or older * Have documented or reported gross hematuria within 3 month of study enrollment * Willing and able to give written informed consent Exclusion Criteria (patients must not): * Have history of BCa * History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years * Have a known active urinary tract infection or urinary retention * Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) Serum creatinine value can be up to 60 days before consent, otherwise repeat * Have ureteral stents, nephrostomy tubes or bowel interposition * Have recent genitourinary instrumentation (within 10 days prior to signing consent) * Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Bladder cancer

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Department of Urology, Nara Medical University

    Nara, Japan

  • Nara Precfecture Seiwa Medical Center

    Nara, Japan

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Rochester Medical Center

    Rochester, New York, 14627, United States

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