A study looking at a new way of finding abnormal cells in the mouth

Please note this trial is no longer recruiting patients.

This study is looking into a new way of collecting and testing cells from the lining of the mouth that could help to diagnose mouth cancer.

To diagnose mouth cancer, doctors need to take a sample of tissue (a biopsy) from the inside of your mouth. Usually, they make the area numb with a local anaesthetic, then cut the tissue with a scalpel. This is called a surgical biopsy.

By looking at the tissue under the microscope, they can see if the cells are cancerous. And they can see if there are any early cell changes that have the potential to turn into cancer in the future (dysplasia).

Researchers are looking for a new way of collecting abnormal cells without taking a surgical biopsy and testing them quickly. In this study, they take the cells from the lining of the mouth using a small plastic brush (similar to a toothbrush) and testing them using something called dielectrophoresis (dye-el-ek-tro-for-ee-sis).

Dielectrophoresis involves putting the cells into a small device that contains an electric field and a small camera to watch their movements. As cancerous cells are different from normal cells, their movements within the electric field should be different. The device will automatically identify cells that have abnormal movements (cancerous cells) and will quickly show the results on a computer screen.

Please note – you will not benefit directly from taking part in this study and it will not affect any treatment you may have. It is possible that the results of this study may help to improve how mouth cancer is diagnosed in the future.

Recruitment

Start 01/06/2009

End 31/12/2011

Phase

Other

Who can enter

You can enter this trial if you are having a surgical biopsy because you have symptoms that could be caused by mouth cancer or abnormal cells (dysplasia) in the lining of the mouth. You can also take part if you have had a biopsy recently and are waiting for an operation to remove mouth cancer.

Trial design

If you agree to take part in this study, the researchers will take 2 samples of cells using a small, plastic brush. This takes less than a minute. They will take one sample from the area where you are having (or have had) the surgical biopsy. They will take another sample from a healthy area of the lining of your mouth.

The researchers will test the cells using dielectrophoresis to see if the abnormal cells move in a different way to the healthy ones.

Hospital visits

You can have the brush biopsies when you go to hospital to have your planned surgical biopsy. Or, if you prefer, you can go back a week later to have the brush biopsy. If you have already had a surgical biopsy, the researchers will arrange the brush biopsy at a time that is convenient for you.