RecruitingOBSERVATIONAL

Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer

The UROSCOUT-1 trial is studying a new, simple urine test called a 'urine tumour DNA (utDNA) test.' This test looks for tiny bits of cancer DNA in your urine. Many people with blood in their urine (a symptom that could indicate bladder cancer) currently need an examination of their bladder with a camera, called a cystoscopy. This can be uncomfortable and often doesn't find cancer. This study wants to see if the new urine test can accurately identify who might have bladder cancer, potentially reducing the number of cystoscopies needed. The main goal is to make diagnosing bladder cancer less invasive and improve how patients experience the process.

At a glance

Status

Recruiting

Sponsor

Tampere University Hospital

Enrolment target

3,000

Start

08 Jan 2024

Estimated completion

31 Dec 2029

Urothelial Carcinoma

What is this study about?

You're probably reading this because you've experienced blood in your urine, or your doctor has suggested you might need tests to check for bladder cancer. It's completely understandable to feel worried, but it's important to know that blood in the urine can be caused by many things, and often it's not serious.

Currently, if there's a concern about bladder cancer, a common test is a 'cystoscopy'. This is when a doctor uses a thin, flexible tube with a camera on the end to look inside your bladder. While this test is very good at finding cancer, it can be uncomfortable, and many people who have it don't actually turn out to have cancer. This study is exploring a new, much simpler way to check forbladder cancer without needing to go through this invasive procedure right away.

Researchers are looking at a urine test that searches for tiny pieces of DNA from cancer cells that might be shed into your urine. This is often called a 'urine tumour DNA (utDNA) test'. The aim is to see if this test can accurately identify people who might have cancer, and more importantly, people who definitely don't have cancer. If successful, this could mean many fewer people would need to have a cystoscopy, making the diagnostic process much easier and more comfortable for patients like you.

Key takeaways

This study is testing a new, simple urine test for bladder cancer.
It aims to reduce the need for uncomfortable bladder examinations (cystoscopies).
Participation involves providing a urine sample from home.
The study doesn't change your current medical care.
It's for people having tests for suspected bladder cancer for the first time.

Who may be eligible?

This study is looking for adults aged 18 to 100 years old. To join, you must be scheduled to have a cystoscopy, which is an examination of the bladder, because your doctors want to check you don't have bladder cancer. This might be because you've had blood in your urine or for another reason that makes your doctor suspicious of bladder cancer.

You cannot join the study if you have already been diagnosed with bladder cancer or cancer in the upper urinary tract before. This study is for people who are currently being checked for the first time or where cancer hasn't been found before.

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 between 18 and 100 years old?
Are you scheduled for a cystoscopy to check for bladder cancer?
Have you *not* been told you have bladder cancer before?
Are you happy to provide informed consent and a urine sample?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will be very simple. You will be asked to provide a urine sample by mail. This means you won't need extra hospital visits for the study itself. The researchers will then analyse your urine sample in a special lab. They won't know your diagnosis when they test the sample, to make sure the results are as fair as possible. This process won't change your planned medical appointments or treatments. The study aims to see how well the urine test works compared to current methods, so your doctors will still follow the usual procedures to find out if you have cancer.

Potential risks and benefits

Taking part in this study involves very minimal risk, as it only requires providing a urine sample, which does not impact your health or alter your standard medical care. The potential benefit is that your participation could help researchers develop a new, less invasive way to diagnose bladder cancer in the future, potentially reducing the need for uncomfortable procedures like cystoscopies for many patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (8)

Jesse Brown Department Of Veterans Affairs Medical Center
Verified postcode
Chicago, United States· Not yet recruiting
Vancouver Prostate Centre
Verified postcode
Vancouver, Canada· Recruiting
Helsinki University Hospital
Verified postcode
Helsinki, Finland· Recruiting
Satasairaala Hospital
Verified postcode
Pori, Finland· Recruiting
Seinäjoki Central Hospital
Verified postcode
Seinäjoki, Finland· Recruiting
Tampere University Hospital and Tampere University
Verified postcode
Tampere, Finland· Recruiting
Turku University Hospital
Verified postcode
Turku, Finland· Recruiting
Kindai University Hospital
Verified postcode
Osaka, Japan· Recruiting

Common questions

What is bladder cancer?

Bladder cancer happens when abnormal cells grow in the lining of the bladder. It's often found because of symptoms like blood in the urine.

What is a cystoscopy?

A cystoscopy is a procedure where a doctor uses a thin, flexible tube with a tiny camera to look inside your bladder to check for any problems.

Is the urine test safe?

Yes, providing a urine sample is a very safe and non-invasive procedure. It doesn't cause any harm.

Will taking part change my normal treatment?

No, taking part in this study will not change how your doctor normally investigates your symptoms or plans your treatment. It's an additional test for research purposes.

How long does the study last?

For you, participation mostly involves providing a urine sample. The overall study will run for a longer period to collect enough information.

How to find out more

Jussi Nikkola, MD PhD

jussi.nikkola@fimnet.fi 03311611 Official trial record

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