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Bladder EpiCheck European Haematuria Study

This research study, called the Bladder EpiCheck European Haematuria Study, is exploring a new urine test for bladder cancer. It's designed for people aged 45 or older who have noticed blood in their urine, a condition known as haematuria. The main aim is to see how accurate the Bladder EpiCheck test is at finding bladder cancer when compared to the usual methods, such as a cystoscopy (a camera examination of the bladder). Researchers hope this study will help confirm if the Bladder EpiCheck can be a reliable and less invasive way to detect bladder cancer early. Taking part involves providing a urine sample and allowing researchers to collect information from your routine medical check-ups.

At a glance

Status
Recruiting
Sponsor
Nucleix Ltd.
Enrolment target
800
Start
20 Jun 2025
Estimated completion
01 Dec 2026

What is this study about?

This study, called the Bladder EpiCheck European Haematuria Study, is looking into a new way to help detect bladder cancer. If you've been told you have blood in your urine (this is called haematuria), your doctor might recommend checks to find out why. One common check is a cystoscopy, where a thin camera is used to look inside your bladder. This study is testing a new urine test called Bladder EpiCheck to see if it can help doctors detect bladder cancer.

The main goal is to find out how well this new urine test works compared to the standard procedures. Researchers want to see if the Bladder EpiCheck test is good at spotting bladder cancer and also good at showing when there isn't any cancer. By comparing it to existing methods, they can understand if it could be a useful tool for doctors in the future.

Ultimately, this research could lead to simpler, less invasive ways to check for bladder cancer, potentially making the diagnostic process easier for patients. It's an important step in improving how we detect bladder cancer early, which is often key to successful treatment.

Key takeaways

  • New urine test for bladder cancer detection.
  • For people aged 45+ with blood in their urine.
  • Compares new test to standard care (cystoscopy).
  • Aims for a simpler, less invasive detection method.
  • Involves providing a urine sample.
  • Does not replace your current medical care.

Who may be eligible?

To be considered for this study, you need to be at least 45 years old. You must also have noticed blood in your urine, either visible or only found during a test, within the last six months. Importantly, you should already be scheduled to have a cystoscopy (a look inside your bladder with a camera) as part of your usual medical care within two months of joining the study. You also need to be able to provide a urine sample of at least 10ml.

There are some reasons why you might not be able to join. For example, if you've had bladder cancer before or if you've had a cystoscopy due to blood in your urine in the last two years. Also, if you've been treated for prostate or kidney cancer within the last year, or if you have an untreated urine infection, kidney stones causing pain, are on dialysis, or have a long-term urinary catheter, you wouldn't be able to take part. Pregnant individuals are also excluded.

Quick self-check
  • Are you 45 years old or older?
  • Have you noticed blood in your urine in the last 6 months?
  • Are you scheduled for a cystoscopy soon (within 2 months)?
  • Have you NOT had bladder cancer in the past?
  • Do you NOT have an untreated urine infection?
  • Are you able to provide a urine sample?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your involvement will be quite straightforward. You will be asked to provide a single urine sample. This sample will be collected at one of your routine medical appointments. The researchers will then compare the results of the Bladder EpiCheck test from your urine sample with the findings from your standard medical checks, such as your cystoscopy and any other tests your doctor normally performs. You won't need extra visits just for the study, as data will be gathered from your existing healthcare appointments. The total duration of your participation will depend on when your standard medical tests are completed, but it's mainly about providing that initial urine sample and allowing access to your usual test results.

Potential risks and benefits

Participating in this study involves very little extra risk beyond your usual medical care, as it primarily uses a urine sample you would already be providing. The main benefit is helping to advance medical knowledge and potentially contribute to developing a new, less invasive way to detect bladder cancer in the future. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care in any way.

Locations (5)

  • NHS Fife
    Dunfermline, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Cambridge, United Kingdom· Recruiting
  • NHS Lothian
    Edinburgh, United Kingdom· Recruiting
  • Guy's and St Thomas
    London, United Kingdom· Recruiting
  • Frimley
    Surrey Quays, United Kingdom· Recruiting

Common questions

What is haematuria?

Haematuria simply means blood in your urine. Sometimes you can see it, and other times it's only found when your urine is tested.

What is a cystoscopy?

A cystoscopy is a common medical procedure where a doctor uses a thin, flexible tube with a camera on the end to look inside your bladder.

Is the Bladder EpiCheck a new treatment?

No, Bladder EpiCheck is a urine test, not a treatment. It's being studied to see if it can help detect bladder cancer.

Will taking part in this study change my medical care?

No, taking part in this study will not change the medical care you receive. Your doctor will continue to treat you as they normally would.

Do I have to pay to be in this study?

No, you will not have to pay to participate in this study. All study-related procedures are covered by the research.

How to find out more

Vered Yayon

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Bladder EpiCheck European Haematuria Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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