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RecruitingNAINTERVENTIONAL

Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)

This study is for people with Lynch syndrome, a condition that increases the risk of certain cancers. We are focusing on urothelial cancers, which include bladder and upper kidney cancers. These cancers are more common in people with Lynch syndrome. We want to see if a new urine test, called a urine tumour DNA (utDNA) test, can find these cancers earlier, even before symptoms appear. Currently, a different urine test (urine cytology) is sometimes used. By finding cancer early, treatment can be more effective. The study aims to compare this new test with existing methods to see if it can improve how we screen for these cancers in people at high risk.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Tampere University Hospital
Enrolment target
200
Start
10 Apr 2023
Estimated completion
31 Dec 2034

What is this study about?

This study is called the LS-URO Study, which is short for "Lynch Syndrome Urothelial Cancer Screening." This research is about finding a better way to check for certain cancers in people who have Lynch syndrome. Lynch syndrome is a condition that you can inherit from your parents, and it means you have a higher chance of developing certain types of cancer during your life. The study focuses on cancers of the urinary tract, specifically bladder cancer and cancers in the tubes connecting the kidneys to the bladder.

These types of cancer, called urothelial cancers, are quite common in people with Lynch syndrome. In fact, up to one in four people with Lynch syndrome might develop one of these cancers. Finding these cancers early is really important because it means treatments are more likely to work well. At the moment, we don't have the very best ways to screen for these cancers in people with Lynch syndrome.

This study will try a new urine test. This test looks for tiny bits of cancer DNA in your urine. The idea is that if we can find these cancer clues in your urine before you even have any symptoms, doctors can step in sooner. We will compare this new urine DNA test with another type of urine test that is sometimes used now, called urine cytology. By doing this comparison, we hope to learn if the new test is better at catching these cancers early in people with Lynch syndrome, ultimately leading to better health outcomes.

Key takeaways

  • This study evaluates a new urine test for early cancer detection.
  • It's for people with Lynch syndrome, who have a higher risk of certain cancers.
  • The focus is on bladder and upper kidney cancers (urothelial cancers).
  • Early detection can lead to more successful treatment.
  • Participation involves providing urine samples; no new medications are given.

Who may be eligible?

To join this study, you need to be an adult between 50 and 75 years old. It's really important that you have been diagnosed with Lynch syndrome. You also need to be happy to give your permission (informed consent) to take part.

However, you won't be able to join the study if you already have urothelial cancer (bladder or upper tract cancer) at the time the study starts. This study is specifically for finding cancers early in people who don't have symptoms yet.

If you think you meet these requirements and are interested, please talk to your doctor.

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.

  1. Do you have a diagnosis of Lynch syndrome?
  2. Are you between 50 and 75 years old?
  3. Do you currently NOT have bladder or upper kidney cancer?
  4. Are you willing to provide urine samples for research?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide urine samples regularly. These samples will be used for both the new urine tumor DNA test and the standard urine cytology test so they can be compared. You might need to attend clinic appointments for these collections and for any discussions about your results. The study team will explain everything in detail, including how long you will be involved and how many appointments you would need. There are no medications involved in this screening study.

Potential risks and benefits

A potential benefit of joining this study is that we might find any urothelial cancers at a very early stage, which could lead to more effective treatment. You would also be helping researchers learn more about how to screen for these cancers in people with Lynch syndrome, which could benefit many others in the future. There are generally very few risks associated with providing urine samples. The main 'risk' is being contacted about a potential finding from the test, which might require further investigations. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

  • Vancouver Prostate Centre
    Verified postcode
    Vancouver, Canada· Recruiting
  • Tampere University Hospital and Tampere University
    Verified postcode
    Tampere, Finland· Recruiting

Common questions

What is Lynch syndrome?

Lynch syndrome is an inherited condition that increases your risk of certain cancers, especially bowel, womb, and urinary tract cancers.

What is urothelial cancer?

Urothelial cancer is a type of cancer that starts in the lining of your urinary tract, most commonly in the bladder or upper part of the kidneys.

What is a urine tumor DNA test?

It's a new test that looks for tiny pieces of cancer-related DNA in your urine, which could be an early sign of cancer.

Will I have to take any new medicines?

No, this study is about checking for cancer using urine tests, not about taking any new medications.

Who can join this study?

Anyone with a diagnosis of Lynch syndrome, aged 50 to 75, who currently does not have urothelial cancer.

How to find out more

Jussi Nikkola, MD, PhD

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 "Urothelial Cancer Screening in Individuals With Lynch Syndro…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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