"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study to help develop a test to find the causes of blood in the urine (HaBio)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is using blood and urine samples to develop a test that will show why somebody has blood in their urine.
More about this trial
Many people have blood in their urine. Doctors call this haematuria. Haematuria can be a symptom of bladder cancer, but there are other causes too, including kidney stones or a urine infection. If you have blood in your urine, it is important to get it checked out by your doctor.
Your doctor may want to do a test that looks inside your bladder, using a thin tube with a light on the end (a cystoscopy). But having a cystoscopy can be uncomfortable, and is not always useful in helping to make a diagnosis.
So researchers want to develop a simpler test to work out the cause of haematuria. In this study, they will recruit people who have been diagnosed with bladder cancer, and people who have had negative results from bladder cancer tests. They will take blood and urine samples from people in each group. They will measure proteins in the samples to see if there are links between these and different causes of haematuria.
By developing a test using blood and urine samples, researchers hope that in future fewer people would need a cystoscopy. It may also help to work out the cause of haematuria more quickly, so that people can be treated more efficiently.
Who can enter
This study is recruiting 2 groups of people – people in 1 group have bladder cancer, people in the other group don’t (the control group). If the study is suitable for you, a member of the study team will ask if you would like to take part.
You may be able to join the bladder cancer group if you
- Have bladder cancer that has either been diagnosed recently or has come back after treatment, or your doctor thinks you may have bladder cancer
- Have had blood in your urine
- Have had a cystoscopy in the last 6 months or you are going to have a cystoscopy (you must not have had a cystoscopy in the last 2 days)
- Are between 40 and 85 years old
You may be able to join the control group if you
- Have had a negative cystoscopy in the last 3 months and other tests for bladder cancer have also been negative (you must not have had a cystoscopy in the last 2 days)
- Have had blood in your urine
You cannot enter the bladder cancer group if you have had
- Any treatment for bladder cancer in the last 3 weeks
- Any other cancer apart from bladder cancer, unless this has been successfully treated
You cannot enter the control group if you have had bladder cancer, or any other cancer unless this has been successfully treated.
This study will recruit 333 people who have bladder cancer, and 666 people who have tested negative for bladder cancer.
Whichever group you are in, you give a blood sample and a urine sample. A research nurse will record your height, weight and blood pressure. They will also ask about your medical history, lifestyle and any jobs you have had.
The study team will look at any tissue you’ve had removed from your bladder. And they will look at your medical notes. If they find out anything that may help in your treatment, they will talk to your specialist about this. The team will review your medical notes again in 3 years’ time.
The study team will hold a meeting when the study is nearly completed, to discuss how it is going, and any future plans. If possible, they would like you to come along so they can hear your views and comments. But they will not be able to talk about people’s personal medical situation at this meeting. The team will tell you more about this if you are interested.
You will be asked to attend an appointment with a member of the research team. This may be on the day that you are going to hospital for other tests. No other appointments will be necessary unless you would prefer to take part on a different date which is suitable for you and the research team.
You may have a small bruise where you give your blood sample.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Kate Williamson
Belfast Health & Social Care Trust
Invest Northern Ireland
Northern Ireland Clinical Trials Centre
Queen's University Belfast
Randox Laboratories Ltd