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

Please note this trial is no longer recruiting patients.

This trial is to find out if a new urine test for a protein called Mcm5 can help diagnose transitional bladder cancer.

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 is being investigated to see if it can be used to diagnose bladder cancer. A sample of urine is tested for a protein called Mcm5. We must be sure this test is accurate and reliable before it is widely used. If it is reliable, it may be helpful for diagnosing bladder cancer, monitoring how well treatment is working or checking to see if a cancer has come back.

The aim of this trial is to see how reliable the Mcm5 urine test is. The results of this test will be compared to standard tests for diagnosing bladder cancer.

Recruitment

Start 23/07/2003

End 01/07/2006

Phase

Phase 3

Who can enter

You can enter this trial if you fit one of the following situations

You are having tests because you have blood in your urine
You are being seen regularly to check whether a transitional cell bladder cancer has come back since you were first treated
You are having immunotherapy or chemotherapy treatment for your bladder cancer

You cannot enter this trial if you

Have had surgery to your bladder in the last 2 weeks
Have had any other cancer within the last 5 years

Trial design

This trial aims to recruit 3000 patients. If you are being seen at The Freeman Hospital in Newcastle-upon-Tyne for suspected bladder cancer, or have been diagnosed with bladder cancer, you may be asked if you want to take part. If you decide to take part, you will have a urine sample taken. This is done as well as other routine tests for bladder cancer, such as cystoscopy . Your urine sample will be tested for the Mcm5 protein

This is an observational study. The urine will be tested at a later date. The results will not be used to decide on the treatment that is best for you.

Hospital visits

You will be asked for a urine sample while you are at the hospital having tests. If you need to go to the hospital again for further tests, you will be asked to provide another urine sample. You will not need to make any extra trips to the hospital because you are taking part in this study.

Side effects

There are no side effects to providing this urine sample. If you are diagnosed with bladder cancer , the treatment you will then receive will have some side effects.

There is information in the main section of the CancerHelp UK website on the treatment of bladder cancer including possible side effects.