A study looking at the Mcm5 protein test as a way of diagnosing cancer of the bile duct, gallbladder or pancreas

Cancer type:

Bile duct cancer

Biliary tree cancers

Gallbladder cancer

Pancreatic cancer

Status:

Results

Phase:

Other

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

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

Doctors hoped that a test looking for a protein called Mcm5 would be better at diagnosing these cancers. Mcm stands for ‘mini chromosome maintenance’ protein. This was a new test. Doctors needed to make sure it was accurate and reliable.

In this trial, patients had the Mcm5 test as well as the usual tests, not instead of them. Results of the MCM5 test did not affect peoples’ treatment or care. The aim of the trial was to find out if testing for the Mcm5 protein could help diagnose cancer of the bile duct, gallbladder or pancreas.

Summary of results

The trial team found that testing a sample of bile Open a glossary item for Mcm proteins was better at picking up cancer than the standard way of examining cells.

The trial recruited people who were having tests because they had a narrowing (a stricture) of the bile duct Open a glossary item . The tests showed that some of the people had cancer of the bile duct, gallbladder or pancreas. Others were found not to have cancer.

102 people were included in the study
Everybody taking part had a test called an ERCP
Doctors removed a sample of cells to be looked at under the microscope (cytology ), which is a standard test for diagnosing cancer
Doctors also took a sample of bile

As well as the standard cytology, the trial team looked for Mcm proteins in the cell samples, and in the samples of bile. They compared their findings with biopsies Open a glossary item taken from people who went on to be diagnosed with cancer of the bile duct, gallbladder or pancreas.

They found that in people who were diagnosed with cancer, the amount of Mcm proteins in the bile sample was very high. And in people who did not have cancer, it was very low.

These results show that the test can help to diagnose cancer. The researchers are now studying it in a larger trial to see how reliable it is.

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.