A trial to test a new way of looking at cervical smear tests (MAVARIC)

This trial is testing a new way of looking at cell samples (cytology) taken during a smear test. It is called MAVARIC, which stands for Manual Assessment Versus Automated Reading In Cytology.

A cervical smear test can pick up abnormal cells on the cervix. As these cells are pre-cancerous, the treatment you have can prevent cervical cancer.

When you have a smear test, the doctor or nurse takes a sample of cells from your cervix. They then transfer these cells onto a slide or into a small container of liquid, and send them to the laboratory. In the laboratory, trained technicians look at the cells under a microscope.

This study is testing a new, computer guided method of looking at the cells. The new technology highlights the most abnormal area of the slide, so it can be examined more closely.

The researchers want to compare the new technology with the current way of looking for abnormal cells, to see which is the most accurate. This will not affect how you have your smear test or how you get the results.

The researchers will also test some of the cell samples with borderline or mild changes for the human papilloma virus (HPV). Having certain types of HPV increases your risk of having abnormal cells on the cervix. Doctors want to find out if carrying out an HPV test can help them to work out which women are most at risk and therefore need to have a colposcopy.

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/03/2006

End 31/01/2009

Phase

Other

Who can enter

You can enter this trial if you are invited to go for a cervical smear test at one of the GP practices in Greater Manchester taking part in the study.

Trial design

The trial will involve 75,000 samples from women attending one of the participating GP practices for routine cervical screening. Women will receive some information about the trial when they get their invitation for screening in the post.

This is a randomised trial. The samples will be put into one of 2 groups by a computer. Neither you, nor the doctors or nurses at your GP practice will be able to decide which group your sample goes in. The samples in group 1 will be read manually by a technician. The samples in group 2 will be read by a technician. And they will be looked at using the new technology.

If your smear test result is normal, you will be invited for your next routine smear test by your GP.

If your sample shows that you have borderline changes or mild dyskaryosis, the laboratory may test it for the HPV virus. This is because having certain types of HPV virus can put you at higher risk of cancer of the cervix. If the cells do contain the HPV virus, you will be offered a colposcopy. If the cells are HPV negative, you will be asked to have a repeat smear (usually in 6 months time).

If your smear test shows that you have moderate or severe dyskaryosis, your doctor will recommend that you have a colposcopy. This is the current standard practice. So you would have this test whether you take part in this trial or not.

Hospital visits

Most women will not have any extra appointments as a result of taking part in this trial. But if you have borderline changes or mild dyskaryosis and the cells contain the HPV virus, you will have a colposcopy.

Side effects

This trial does not involve any treatment over and above routine care, so there are no side effects from taking part. Having a smear test might be uncomfortable but it shouldn’t hurt.