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New urine test aims to catch bladder cancer early

NCT ID NCT01563796

Diagnosis Sponsor: Medical Diagnostic Laboratories, 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a urine test that measures a protein called DEK to help diagnose bladder cancer. It included over 1,100 people with blood in their urine or painful urination. The goal was to see if the test could accurately detect cancer without invasive procedures. However, the trial was stopped early, so the final results are not available.

What this could mean

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

Active substance
DEK ELISA urine test
What this could lead to
If successful, this could provide a simple, non-invasive urine test to help diagnose bladder cancer earlier.
What could go wrong
The trial was terminated, so results are incomplete. The test may not be accurate enough to replace standard methods like 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

1,115 people

The number who actually took part.

Start date

Mar 2012

Finished

Oct 2016

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

patients visiting urologist (primary care, referral, community, university or hospital).

Ages

25 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: * Patients who are at least twenty-five (25) years of age with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones. Exclusion Criteria: * Females who are pregnant (ascertained by history) * Females who are menstruating or within three (3) days of their last menstruation * Patients who have undergone invasive procedures of the urogenital tract in the past two (2) months * Patients with a history of transitional cell carcinoma (TCC) of the urinary tract

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Conditions

The condition(s) this trial relates to.

Dysuria Hematuria 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 Dysuria Hematuria

Contacts and locations

Locations

  • Staten Island University Hospital

    Staten Island, New York, 10305, United States

More trials for these conditions

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