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Urine test could spare thousands from unnecessary cancer scares

NCT ID NCT07307300

Diagnosis Sponsor: Christian Bolenz 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a urine test (Xpert Bladder Cancer Detect) to see if it can accurately identify people with hidden blood in their urine who are at higher risk for bladder cancer. About 1,475 adults over 40 will provide a urine sample and answer symptom questionnaires, then undergo standard cystoscopy and follow-up. If successful, the test could help doctors decide who needs invasive procedures and who can safely avoid them.

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 1,475 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 over 40 years with non-visible blood in the urine. Participants are either initially identified by referring primary care physicians and further evaluated at the study sites for possible inclusion, or they are directly identified at the study sites during routine evaluation when microhematuria is detected. Recruitment takes place at multiple urology clinics in Germany and Austria.

Ages

40 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: * Signed consent form after being informed about the study * Willing and able to follow the study requirements * Non-visible blood in the urine, found within the past 6 months * Age over 40 years Exclusion Criteria: * Previous diagnosis of bladder cancer * Too much protein in the urine (shown by urine test) * Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test) * Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale * Signs of kidney-related blood in the urine (found by special urine test) * Bladder examination with a camera (cystoscopy) within the past 12 months * Pregnancy * Visible blood in the urine within the past year * Previous surgery on the urinary tract * Previous radiation treatment to the pelvic area * Permanent tube or foreign body in the urinary tract (such as a catheter) * Participation in another clinical study at the same time or within 30 days before this study * Detained under legal or official authority * Medical, psychological, or social problems that would make it hard to follow the study requirements * Not able to understand the study information well enough to give consent

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Conditions

The condition(s) this trial relates to.

Hematuria urinary bladder carcinoma

As listed by the trial registrant

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

Hematuria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Urology and Pediatric Urology University Hospital Ulm

    Ulm, 89081, Germany

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