A study of a urine test to help diagnose bladder cancer that has come back (Arquer 006)

Cancer type:

Bladder cancer

Status:

Results

Phase:

Other

This study was done to find out whether the ADXBLADDER urine test can help to diagnose bladder cancer that has come back after treatment.

It was open for people to join between 2017 and 2019. The research team published the results in 2021.

More about this trial

People who have treatment for bladder cancer have regular follow up appointments. The doctors check for any signs that the cancer has started to grow again. This is called recurrent cancer.

When this trial was done, people usually had a test called a cystoscopy. This is when doctors use a small tube with a camera on the end to look inside the bladder. Some people also had a cytology Open a glossary item test. This is where doctors look at cells in the urine under a microscope.

Researchers wanted to see if a test called ADXBLADDER could be useful to diagnose bladder cancer that has started to grow again. 

You may hear this test called the MCM5 test. This is because it measures the amount of a protein called MCM5 in urine. 

The main aim of this trial was to find out whether the ADXBLADDER test can help diagnose bladder cancer that has come back. 

Summary of results

Study design
This study was for people having follow up appointments after treatment for early stage bladder cancer. This is also called non muscle invasive bladder cancer, or superficial bladder cancer.

They were due to have a cystoscopy test to check for signs that the cancer had come back. They also gave a urine sample so researchers could measure the amount of MCM5.

Results
The research team compared the results of the ADXBLADDER test with cystoscopy results for 1,431 people. They found that the ADXBLADDER test was correct for 93 out of 100 people (93%) whose cancer had not come back.

When they looked in more detail, they found it was most accurate for people with cancer at a high risk of coming back. In that group, the test was correct for 99 out of 100 people (99%) whose cancer had not come back.
 
The research team also compared results of the cell analysis (cytology) and the ADXBLADDER test for 514 people. They found that the ADXBLADDER test was better than cytology at diagnosing bladder cancer that has come back. It is also cheaper, quicker and easier to do.

The team suggest that it could become an alternative to having a cytology test. And that it could reduce the number of cystoscopy tests people need.

More detailed information
There is more information about this research in the references below. 

Please note, these articles may not be in plain English. They have been written for health care professionals and researchers.

Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Nonmuscle Invasive Bladder Cancer Followup: A Blinded, Prospective Cohort, Multicenter European Study. 
M Roupret and others
Journal of Urology. 2020, Volume 204, Issue 4, pages 685-690.

Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study
P Gontero and others
British Journal of Urology International (BJUI), 2021. Volume 198, pages 198-204

Where this information comes from    
We have based this summary on the information in the articles above. They have been reviewed by independent specialists (peer reviewed Open a glossary item) and published in medical journals. We have not analysed the data ourselves. As far as we are aware, the links above are active and the articles are free and available to view.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Jacqueline Stockley 

Supported by

Arquer Diagnostics Ltd

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15981

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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