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New urine test could spot bladder cancer when others Can't

NCT ID NCT06870253

Diagnosis Sponsor: Pangea Laboratory LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new urine test called Bladder CARE™ to see if it can detect bladder cancer in people whose standard tests (cystoscopy or cytology) gave unclear results. About 80 adults with suspicious but inconclusive findings will provide a urine sample before their routine cystoscopy. Researchers will then check how well the test performs compared to standard diagnostic methods, with follow-up at 6 and 12 months.

What this could mean

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

Active substance
Bladder CARE™ Assay (urine-based diagnostic test)
What this could lead to
If successful, this test could provide a non-invasive way to diagnose bladder cancer when standard methods are inconclusive, reducing the need for invasive procedures.
What could go wrong
This is an early observational study with only 80 participants, so results may not apply to everyone. The test may not be accurate enough to replace current methods.

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 80 people

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

Started

Jun 2025

Expected to finish

Mar 2027

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

Urology practice

Ages

18 to 99 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. Patients ≥ 18 years of age at time of informed consent. 2. Subject or the subject's legally authorized representative provides written informed consent. 3. Subject is willing to follow all study procedures and available for the duration of the study. 4. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening. 5. Subject is scheduled for initial or repeat cystoscopy, with or without pathology. 6. Subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology. Exclusion Criteria: 1. Pregnant or planning to become pregnant at the time of screening. 2. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer. 3. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection. 4. History of augmentation cystoplasty. 5. History of continent cutaneous diversion or ileal conduit. 6. History of orthotopic bladder substitution or orthotopic neobladder. 7. Concomitant use of an investigational drug which has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of urine specimen. 8. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment. 9. An active malignancy (bladder or other) diagnosis within 3 months of study enrollment. 10. Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma Hematuria transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Urothelial carcinoma bladder

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.