A trial looking at the Mcm5 protein test to diagnose cancer of the bile duct, gallbladder or pancreas (TRANSBIL)

This trial is looking at a new test called the Mcm5 protein test to see if it can help diagnose cancer of the bile duct, gallbladder or pancreas.

Cancer of the bile duct, gall bladder or pancreas is usually diagnosed using blood tests, scans and a biopsy. But it is not always easy to be sure of the diagnosis based on these results.

Doctors hope a test that looks for a protein called Mcm5 will be better at diagnosing these cancers. Mcm stands for ‘minichromosome maintenance’ protein. This is a new test. Research so far suggests it is very accurate. But we need to make sure it is reliable before it can be widely used to diagnose cancer.

In this trial, patients will have the Mcm5 test as well as the usual tests, not instead of them. If you take part, the results of the Mcm5 test will not affect your treatment or care. But if the trial proves the Mcm5 test is good enough, it may benefit other patients in the future.

The aim of this trial is to find out if testing for the Mcm5 protein can help diagnose cancer of the bile duct, gall bladder or pancreas.

Recruitment

Start 01/03/2009

End 28/02/2014

Phase

Other

Who can enter

You can enter this trial if you are at least 18 years old and;

Have cancer of the bile duct, gall bladder or pancreas or
Are having tests to find out if you have cancer of the bile duct, gall bladder or pancreas or
Have a benign (non cancerous) condition of the bile duct, gall bladder or pancreas, such as pancreatitis, sclerosing cholangitis or jaundice caused by stones in the bile duct

Trial design

This trial will recruit more than 200 people into two groups.

Group 1 will be those with suspected cancer, or those who have already been diagnosed with cancer.

Group 2 will be those with a non cancerous condition (see eligibility criteria above). They are the ‘control group’, and they have the same tests as group 1. This is to make sure the Mcm5 test is positive for cancer, but negative for other conditions.

First, you will have standard tests such as blood tests, and ultrasound scan or a CT scan. You may have had these tests already, but your doctor has decided you need a biopsy as well.

After these tests, the doctors will take a biopsy. To do this they will either pass a tube down through your mouth and throat, through your stomach and into your gall bladder or pancreas (an ERCP). Or they will use a needle through your skin.

If you have an ERCP, the doctors will also take a small sample of fluid called bile that is stored in the gall bladder. And they will remove a few cells using a very small brush.

The staff in the lab will test these samples in the usual way. But they will also test them for the Mcm5 protein.

Hospital visits

You will not have any additional tests for this trial. But the doctors will take some extra samples when you have a biopsy. You should not have to stay in hospital as a result of taking part in this trial.