Clinical Research Directory

Real-time Molecular Diagnosis of Oral Precancer

The "Real-time molecular diagnosis of oral precancer" or the LIP study is testing a new device for the detection of cancer in the mouth. Oral cancers are serious and devastating illnesses, especially if detected at a late stage. Currently, the detection of oral cancer relies on testing a biopsy, which involves cutting a small section of tissue from the mouth and sending it to the pathology laboratory for further testing. A doctor or dentist taking the biopsy must rely on their own eyesight and experience to spot areas of concern. It can therefore be difficult to detect the earliest stages of cancer. At times, cancer tissue is only detected because it has already developed, and this affects the success of the treatment. The device tested in this study uses a laser beam to scan areas inside the mouth and a computer collects information about the scan. The goal of this project is to train the computer software in the device to recognize pre-cancer and cancer from normal scans. Patients who need to have a biopsy due to suspected pre-cancer or cancer in the mouth will be scanned with the device. Biopsy reports will be used to tell the software which scans were from pre-cancer or cancer or non-cancer tissues. Volunteers with healthy oral tissue will be included to further test the computer software. Secondary aims include collecting pilot safety data and feedback regarding the use of this device. If successful, the results from this pilot study will lead to a bigger trial to further study how the device can be used for cancer diagnosis.