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Simple urine test could spot bladder cancer before it spreads

NCT ID NCT05347342

Diagnosis Sponsor: Cedars-Sinai Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a new urine test to detect bladder cancer early in people at high risk, such as smokers over 50. Researchers will check how accurate the test is and use the data to build a risk calculator. The goal is to offer a non-invasive way to catch the disease sooner.

What this could mean

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

What this could lead to
If successful, this could lead to a simple, non-invasive urine test to catch bladder cancer early in people at high risk.
What could go wrong
This is an early-stage study with 173 participants, so results may not apply to everyone. The test may not be accurate enough for widespread use.

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

173 people

The number who actually took part.

Started

Apr 2022

Expected to finish

Jan 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

Men and women 50 years and older who have greater than a 20 pack year history of tobacco use.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Participants must be: 1. Age 50 years or older 2. \>20 pack year history of tobacco exposure 3. Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible. 4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic 5. Willing and able to give written informed consent 6. Willing to provide voided urine sample 7. Be able and willing to complete semi-annual research clinic visits for 4 years Exclusion Criteria: Participants must not have: 1. History of hematuria (microscopic or gross) within 2 years of signing consent. 2. Previous history of bladder cancer 3. A known active urinary tract infection or urinary retention 4. An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat. 5. An ureteral stents, nephrostomy tubes or bowel interposition 6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)

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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

  • Long Beach VA Healthcare System

    Long Beach, California, 90712, United States

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