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Simple urine test could spot bladder cancer early

NCT ID NCT06818136

Diagnosis Sponsor: Nucleix Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing a new urine test called Bladder EpiCheck to see how well it can detect bladder cancer in people aged 45 and older who have blood in their urine. Researchers will compare the test results to standard cystoscopy (a camera exam of the bladder). The goal is to find a less invasive way to screen for bladder cancer. The study will enroll 800 participants.

What this could mean

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

Active substance
Bladder EpiCheck (urine test)
What this could lead to
If successful, this urine test could offer a less invasive way to detect bladder cancer early in people with blood in their urine.
What could go wrong
This is an observational study, not a treatment trial. The test is still being validated and may not be as accurate as cystoscopy, the current standard.

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 800 people

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

Started

Jun 2025

Expected to finish

Dec 2026

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

aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma

Ages

45 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: 1. Participants aged 45 years or older 2. Participants who are willing and able to provide written informed consent and adhere to study procedures 3. Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment 4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment 5. Participants who are able to produce at least 10 ml of voided urine Exclusion Criteria: 1. Participants with history of urothelial cancer in the bladder and/or upper urinary tract 2. Participants who had prior cystoscopy for haematuria within the past 2 years 3. Participants previously enrolled in this study 4. Participants treated for prostate cancer within the last 12 months 5. Participants treated for kidney cancer within the last 12 months 6. Participants with untreated urinary tract infection 7. Participants with symptomatic urinary tract stones (e.g. flank pain) 8. Participants on dialysis for end stage renal failure 9. Participants with a long term urinary catheter 10. Pregnancy (self-reported) 11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma Hematuria renal pelvis/ureter urothelial carcinoma urothelial carcinoma

As listed by the trial registrant

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

Cystoscopy Hematuria Urothelial carcinoma bladder Urothelial carcinoma of the renal pelvis and ureter Urothelial carcinoma of the urinary bladder

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, United Kingdom

  • Frimley

    RECRUITING

    Surrey Quays, United Kingdom

  • Guy's and St Thomas

    RECRUITING

    London, United Kingdom

  • NHS Fife

    RECRUITING

    Dunfermline, Fife, KY12 OSU, United Kingdom

  • NHS Lothian

    RECRUITING

    Edinburgh, United Kingdom

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