A study looking at a new way of testing for mouth cancer

This study is looking at a system to diagnose mouth cancer using a brush to collect abnormal cells. In the UK, it is for people under the care of the Charles Clifford Dental Hospital in Sheffield.

If you have a white patch inside your mouth and the cause isn’t clear, your doctor may take a sample of the abnormal tissue. They do this by cutting a circle of tissue out from the affected area with a small knife (scalpel), under local anaesthetic. This is called a scalpel biopsy. The doctor sends this to the laboratory and a pathologist examines the cells under a microscope.

This study is looking at a new way of collecting and diagnosing abnormal mouth cells. It uses a small soft bristle brush, which the doctor rubs over the abnormal area to remove some cells. A computer then studies the cells and gives a diagnosis. This test should cause less discomfort than the scalpel biopsy. And results should be back within minutes, rather than days.

The researchers will take samples from people who have abnormal and cancerous areas in their mouths, and from people with no mouth symptoms. They will also ask those taking part and their doctors what they think of this procedure, and how it compares to the standard scalpel biopsy used at the moment. The aims of this study are to

Develop and make the system work as well as possible to identify cells and biomarkers
Make sure the system recognises healthy, abnormal (dysplastic) and cancerous mouth cells, and test how well it does this

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan. But the results of the study will be used to help people in the future.

Recruitment

Start 13/08/2010

End 22/09/2012

Phase

Pilot

Who can enter

In the UK, this study is for people under the care of the Charles Clifford Dental Hospital in Sheffield. Other people are taking part at 3 centres in the USA. People will be asked to take part if they are at least 18 years old and in one of the following situations

You have a suspicious area in your mouth at least 5mm across, which your doctor thinks may be cancer, and you are due to have a biopsy
You have had a biopsy in the last month which has shown mouth cancer, and you have a remaining area of cancer at least 5mm across, and 5mm away from your earlier biopsy site
You have a healthy mouth with no suspicious areas (this only applies to the centres in the USA)

You cannot enter this study if you have any condition that would affect your ability to take part – you can check this with your doctor.

Trial design

This study will recruit 1,000 people into 3 groups. The group you are in depends on your situation. Everyone will have 2 brush biopsies, and give the study team permission to look at their medical or dental notes.

The study doctor will take the brush biopsy by placing a small brush over the area they want to sample, and gently twisting it up to 15 times. This will trap cells in the bristles, which can then be sent to be tested.

If you have a suspicious area, you will have a brush biopsy of this, and another of healthy looking tissue on the other side of your mouth. You will then have a scalpel biopsy, in the same way as if you were not taking part in the study.

If you have already had a biopsy that confirmed mouth cancer, you will have a brush biopsy of the remaining area of cancer. And a brush biopsy of healthy looking tissue on the other side of your mouth.

Everyone will then fill out a questionnaire. This will ask you about any pain or discomfort from the biopsies you had. After the study, the team will also ask the doctors taking part what they thought of each biopsy method.

The study team will use their results to develop the system. And to see if it can tell between healthy, abnormal and cancerous areas as accurately as the standard biopsy tests used at the moment.

Hospital visits

If you are asked to take part at the Charles Clifford Dental Hospital in Sheffield, you will come back another day for the study appointment, after you have had time to decide. Having the brush biopsies as well as any planned scalpel biopsies, and completing the questionnaire, will take about an hour.