Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
This study is investigating a new urine test called Xpert® Bladder Cancer Detect (Xpert BC-D). It's designed for people who have tiny amounts of blood in their pee that can only be seen under a microscope. The main goal is to find out if this test can accurately tell doctors which patients might be at a higher risk of bladder cancer. They also want to see if using this new test alongside other information can improve how doctors assess these risks, possibly leading to fewer unnecessary invasive tests. About 20-24 clinics in Germany and Austria will take part, with each person involved for around six months. If successful, this research could help many people avoid uncomfortable investigations.
At a glance
What is this study about?
This study is focused on people who have what's called 'microscopic haematuria'. This simply means there's a tiny bit of blood in their urine that isn't visible to the naked eye but can be seen when tested. Often, this is harmless, but sometimes it can be a sign of something more serious, like bladder cancer. Doctors currently have ways to check for this, but they can sometimes be quite invasive, like looking inside the bladder with a camera (a cystoscopy).
Researchers are looking at a new urine test, called Xpert® Bladder Cancer Detect (Xpert BC-D), to see if it can help doctors make better decisions. They want to know if this test can accurately spot people who are more likely to have bladder cancer. The study also aims to figure out if combining the results of this new test with other information doctors already gather can improve risk assessment even further.
The hope is that if this test works well, doctors could use it to help decide who really needs the more invasive tests and who doesn't. This could mean fewer people going through uncomfortable procedures, making the diagnostic process much easier and less worrying for patients. The study involves looking at your urine sample and asking about your symptoms.
Key takeaways
- New urine test for people with non-visible blood in their pee.
- Aims to improve bladder cancer risk assessment and potentially reduce invasive tests.
- Involves urine tests, questionnaires, and medical evaluations.
- Participation lasts around six months.
- May help future patients avoid unnecessary procedures.
Who may be eligible?
To join this study, you need to be an adult over 40 years old and have had non-visible blood found in your urine within the last six months. You also need to be able to understand the study information and agree to take part.
There are several reasons why you might not be able to join. For example, if you've already had bladder cancer, or if you've had surgery or radiation treatment to your urinary area. You also can't take part if you have a current urinary tract infection, visible blood in your urine, or certain other medical conditions affecting your kidneys or urinary system. Being pregnant would also prevent you from joining.
Basically, the study is for people who have this specific type of blood in their urine, where doctors are trying to work out the cause, but without other complicating health issues that might affect the results.
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 over 40 years old?
- Was non-visible blood found in your urine in the last six months?
- Have you ever had bladder cancer before? (If yes, you can't join)
- Are you pregnant? (If yes, you can't join)
- Do you have a current urinary tract infection? (If yes, you can't join)
What does participation involve?
If you decide to take part in this study, your involvement would last for about six months. You would have your routine urine sample, which would be tested using the new Xpert® Bladder Cancer Detect test. This test uses leftover urine, so you wouldn't need to provide an extra sample for this specific part.
You would also be asked to fill out some questionnaires about your urinary symptoms. This helps doctors get a full picture of your health. You'd have an initial visit where doctors would do a medical check-up, which might include looking inside your bladder with a camera (a cystoscopy). Then, 3 to 6 months later, you would have a follow-up visit for some additional tests and more questionnaires.
Potential risks and benefits
Locations (1)
- Urology and Pediatric Urology University Hospital UlmVerified postcodeUlm, Germany
Common questions
What is 'non-visible blood in urine'?
It means there are tiny amounts of blood in your pee that can only be seen when it's tested under a microscope, not when you look at it yourself.
What is the Xpert® Bladder Cancer Detect test?
It's a new urine test that researchers are trying to see if it can help doctors work out a person's risk of having bladder cancer.
Will I have to take any new medicines?
No, this study is about a urine test and assessments, not about new medicines. You will continue with any treatment your doctor has prescribed.
How long will I be involved in the study?
If you join, you'll be involved for about six months.
Can I choose not to complete the study once I've started?
Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Christian Bolenz, Univ. Prof. Dr. med.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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