RecruitingObservational

A real-world evaluation of a bladder cancer biomarker pathway

This study explores a new, easier way to check for bladder cancer in people who have blood in their urine. Currently, doctors use a camera test (cystoscopy), which can be uncomfortable. Researchers have developed a new urine test that looks for tiny markers of bladder cancer. This study wants to find out if patients can collect a urine sample at home and send it back to the lab for testing. The goal is to see if this home test could help some patients avoid the camera test in the future. By making diagnosis less invasive, this study hopes to improve how bladder cancer is found and treated.

At a glance

Status

Recruiting

Sponsor

North Bristol NHS Trust

Enrolment target

2,378

Start

01 Feb 2026

Estimated completion

01 Jun 2027

Haematuria/ suspected bladder cancer

What is this study about?

Bladder cancer is a common type of cancer, with about 10,000 new cases in the UK each year. While it's not always life-threatening at first, it can become more serious. Unfortunately, treatments haven't changed much in the last 25 years, so finding better ways to diagnose it early is very important.

When someone has blood in their urine, they are usually sent to the hospital for checks. These often include testing their wee and having a flexible cystoscopy. This is where a thin camera on a tube is put into the bladder to look inside, which can be a bit uncomfortable and means an extra trip to the hospital.

Researchers are now looking at a new testing kit that can check for bladder cancer by finding tiny markers in a patient's urine. This study wants to see how well this new urine test works in real life. It will also check if it's easy and practical for patients to simply provide a urine sample from home and post it back to a lab. The main aim is to see if this home urine test could mean that some patients might not need to have the flexible camera test in the future. This could make getting a diagnosis much more comfortable and convenient.

Key takeaways

Exploring a new, simpler urine test for bladder cancer.
Aims to make diagnosis more comfortable, possibly reducing the need for camera tests.
Involves collecting a urine sample at home and mailing it back.
Minimal risk, no direct personal benefit, but helps future patients.
Only for adults referred for suspected bladder cancer with blood in urine.
Participation will not affect your standard medical care.

Who may be eligible?

You might be able to take part if you are an adult (18 years or older) who has been sent to the hospital because you have blood in your urine, and your doctors suspect you might have bladder cancer.

You cannot take part if you have already been diagnosed with bladder cancer or a similar type of cancer in the last five years. Also, if you have a long-term catheter (a tube in your bladder) or a urostomy (a bag that collects urine), this study might not be suitable for you. Finally, if you've already joined this study before, you can't join again.

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.

Are you 18 years old or older?
Have you been sent to the hospital because you have blood in your urine?
Do your doctors suspect you might have bladder cancer?
Have you NOT been diagnosed with bladder cancer (or similar) in the last 5 years?
Do you NOT have a long-term catheter or a urostomy?
Have you NOT taken part in this specific study before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll still have all your regular hospital tests and appointments for suspected bladder cancer. In addition to this, you will receive a special kit at your home with instructions on how to collect a urine sample. You will then send this sample back to the lab using a free, pre-paid postal service. The urine samples will be given a special ID number so that the lab researchers won't know your name. The research team will also look at your hospital notes (without your name) to see the results of your usual tests. Your involvement will mostly consist of providing that single urine sample from home, alongside your usual care. The total duration of your participation would align with your standard diagnostic pathway, though the study itself runs until mid-2027.

Potential risks and benefits

You won't directly benefit from taking part in this study, but your contribution could help doctors find better, less uncomfortable ways to diagnose bladder cancer for future patients. There are very few risks involved. The main potential difficulty might be if you have trouble getting to a post box or have mobility issues that make it hard to collect or send the sample. You are always free to change your mind and stop participating at any time without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

North Bristol NHS Trust
City only
Bristol, England
Royal United Hospitals Bath NHS Foundation Trust
City only
Bath, England
Gloucestershire Hospitals NHS Foundation Trust
City only
Cheltenham, England
Somerset NHS Foundation Trust
City only
Taunton, England
Great Western Hospitals NHS Foundation Trust
City only
Swindon, England
GP Care
City only
BRISTOL, England

Common questions

What is 'blood in my urine' also called?

Doctors often call it 'haematuria'.

What is a flexible cystoscopy?

It's a test where a small, flexible camera is used to look inside your bladder to check for problems.

Will my GP or hospital know I'm in the study?

Yes, your medical team will be aware of your participation, but your name won't be linked to the urine samples for the research team.

Do I have to pay to send the urine sample back?

No, the kit includes free return postage, so you won't have to pay anything.

When does the study finish?

The study is expected to finish around June 2027.

How to find out more

Jonathan Aning

jonathan.aning@nbt.nhs.uk +44 0117 414 9330 Official trial record

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