RecruitingNot ApplicableObservational

Bladder EpiCheck - testing a urine test to help detect bladder cancer in people with blood in their urine

Finding blood in your urine can be unsettling. In the NHS, doctors usually investigate this using a cystoscopy, where a thin, flexible camera looks inside your bladder. While this test is very effective, researchers want to find simpler, less invasive ways to detect bladder cancer. This clinical study is evaluating a new urine test called Bladder EpiCheck. The test looks for small biological signals in urine that could show if bladder cancer is present. Researchers will compare the test results against standard camera checks to see how accurate it is. To join, you must be 45 or older, have had blood in your urine in the last six months, and already be booked for a bladder camera check within 60 days. Taking part only requires giving one urine sample at your planned hospital visit. It will not change your normal NHS treatment.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Nucleix (Israel)

Enrolment target

600

Start

20 Jun 2025

Estimated completion

30 Nov 2026

Urothelial carcinoma

What is this study about?

Blood in your urine (known medically as haematuria) is a common symptom that always needs checking. While it is often caused by minor issues like a water infection, it can sometimes be an early sign of cancer in the bladder or urinary system. At present, the most reliable way to check the bladder is a cystoscopy, which involves passing a tiny camera through your water pipe. Although safe, this can feel uncomfortable or stressful for many patients.

Researchers are studying a new urine test called Bladder EpiCheck. When bladder cells shed into the urine, this test looks for specific chemical changes that occur in cancer cells. The study aims to see how well the test can tell the difference between people who have bladder cancer and those who do not. Researchers will also check how good the test is at detecting more aggressive forms of the disease compared to current laboratory tests.

By taking part, you can help doctors understand whether a simple urine test could one day reduce the need for camera examinations. If proven accurate, tests like Bladder EpiCheck could make diagnosing bladder conditions quicker, easier, and much more comfortable for NHS patients in the future.

Key takeaways

Tests whether a new urine test called Bladder EpiCheck can accurately spot bladder cancer.
Open to adults aged 45 and over who have recently had blood in their urine.
Requires only one small urine sample during your existing hospital appointment.
Does not replace your planned camera check or change your standard NHS care.
Aims to help make future bladder cancer testing simpler and less invasive.

Who may be eligible?

You may be able to join this study if you are 45 years of age or older and have had blood in your urine within the last six months. This includes blood you could see yourself, or invisible blood discovered during a routine urine test by your GP. You must also already be scheduled to have a bladder camera examination (cystoscopy) within the next 60 days, and be able to provide a small urine sample.

You will not be able to participate if you have had bladder cancer in the past, or if you had a bladder camera check for bleeding within the last two years. The study is also not suitable for people treated for kidney or prostate cancer in the past 12 months.

Additionally, you cannot take part if you currently have an untreated urine infection, painful kidney stones, a long-term urinary catheter, or if you are receiving kidney dialysis. The study is also not open to anyone who is pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 45 or over.
I have had visible or hidden blood in my urine in the past 6 months.
I am booked for a bladder camera examination (cystoscopy) in the next 60 days.
I have never been diagnosed with bladder cancer.
I have not had treatment for kidney or prostate cancer in the past year.
I do not currently have an untreated urinary tract infection or painful kidney stones.

Answer every question to see your result.

What does participation involve?

Taking part in this study is designed to be straightforward and will not require any extra hospital visits. When you attend your already scheduled hospital appointment for your bladder camera check, a member of the healthcare team will ask you to provide a single urine sample (at least 10 millilitres, or about two teaspoons).

Your urine sample will be sent to a specialist central laboratory for the Bladder EpiCheck test. Because this test is still being researched, neither you nor your doctors will receive the test results, and it will not change any part of your planned NHS care. You will continue with your standard camera examination and any other routine tests exactly as planned. Your participation finishes once you have provided the sample, with no further study visits or follow-up appointments required.

Potential risks and benefits

There are no direct medical benefits to you from taking part, but your sample could help improve how bladder cancer is diagnosed for future NHS patients. There are no physical risks or painful procedures involved, as the study only requires you to pass urine into a container. Your routine hospital care will go ahead as normal. Joining is entirely voluntary, and you are free to change your mind and withdraw at any time without your regular NHS treatment or legal rights being affected.

Locations (5)

Western General Hospital
Approximate
Edinburgh, Scotland
Frimley Health NHS Foundation Trust
City only
Camberley, England
NHS Fife
City only
Kirkcaldy, Scotland
Addenbrookes Hospital
City only
Cambridge, England
Guys Hospital
City only
London, England

Common questions

Will the urine test replace my scheduled camera examination?

No. You will still have your planned camera check (cystoscopy) and any other usual hospital investigations. The study test is for research only.

Will I or my doctor find out the results of the Bladder EpiCheck test?

No. Because the test is still being evaluated, the results are kept private for research purposes and will not be shared or used to guide your care.

Do I have to travel to a different hospital or make extra visits?

No. The urine sample is collected during the same hospital visit you already have booked for your routine bladder examination.

Does providing the sample hurt?

Not at all. You simply need to pee into a standard specimen container, just like a regular urine test at your GP surgery.

What happens if I decide I no longer want to take part?

You can withdraw from the study at any point. You do not need to give a reason, and your normal NHS care will continue unaffected.

How to find out more

Jack Kerrigan

jack@lindushealth.com +44 (0)808 1893802 Official trial record

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