A trial looking at the new Mcm5 test to diagnose transitional cell bladder cancer

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Cancer type:

Bladder cancer
Transitional cell cancer




Phase 3

This trial was to find out if a new urine test for a protein called Mcm5 could help diagnose transitional bladder cancer. This trial was supported by Cancer Research UK.

Bladder cancer is usually diagnosed by looking inside the bladder with a tiny camera (a cystoscopy). Doctors are trying to find an easier and less invasive way of diagnosing bladder cancer.

A new urine test was investigated to see if it could be used to diagnose bladder cancer. This test looked for a protein called Mcm5 in the urine. Doctors needed to be sure this test was accurate and reliable before it was widely used. If found to be reliable, it may help to diagnose bladder cancer, monitor how well treatment works or check to see if a cancer has come back.

The aim of this trial was to see how reliable the Mcm5 urine test was. The results of this test were compared to the standard urine test for diagnosing bladder cancer.

Summary of results

The trial team found that the Mcm5 urine test was as reliable and accurate as the standard NMP22 urine test for diagnosing bladder cancer.  

This trial recruited 1,677 people.

Of the 1,564 urine samples they tested using the Mcm5 test, 210 were positive for bladder cancer. Of the 1,396 samples they tested using the NMP22 test, 195 were positive.

The researchers also looked at the urine samples using both tests. They found that together they identified 95 out of every 100 bladder cancers (95%).  

The trial team concluded that the Mcm5 test was just as reliable and accurate as the NMP22 test. They say that using them together could improve the diagnosis of bladder cancer and further trials are being prepared to test this.    

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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

Prof Gareth Williams

Supported by

Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)

Other information

This is Cancer Research UK trial number CRUK/03/013.

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Last review date

CRUK internal database number:

Oracle 237

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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