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Simple urine test could spot bladder cancer early, avoiding unnecessary scopes

NCT ID NCT03193541

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing a new urine test that looks for specific proteins to detect bladder cancer in people who have microscopic blood in their urine (not visible to the naked eye). The goal is to see if this simple, non-invasive test can accurately identify cancer, potentially reducing the need for invasive procedures like cystoscopy. About 900 adults with microscopic hematuria will provide urine samples, and the test results will be compared to standard cystoscopy findings.

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 900 people

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

Started

Dec 2016

Expected to finish

Feb 2029

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 microscopic hematuria within the past 3 months who are referred for cystoscopy and are willing to participate

Ages

18 to 90 years

Sex

Anyone

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 microscopic hematuria within 3 month of study enrollment * Willing and able to give written informed consent Exclusion Criteria (participants must not): * Have history of BCa * History of previous cancer (excluding basal and squamous cell skin cancer) * 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) * 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.

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 in 2 countries. 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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Nara Medical University

    RECRUITING

    Nara, Japan

  • Nara Prefecture Seiwa Medical Center

    RECRUITING

    Nara, Nara, 636-0802, Japan

  • UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center at Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14620, United States

  • VA Long Beach Healthcare System

    RECRUITING

    Long Beach, California, 90822, United States

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