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.

Inclusion criteria for patients 1. Adult aged 18 and older 2. One of the following criteria must be met: 1. Has a medical condition for which biopsy of oral tissue has been indicated. 2. Is undergoing inspection for early oral cancer 3. Willing and able to comply with all study procedures. Exclusion criteria for patients 1. Has a bleeding disorder, such as haemophilia, or has contraindication for having a biopsy. 2. Severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy and any other immunosuppression / immuno-modulation therapy. 3. Has other severe acute or chronic medical or psychiatric condition where use of the device may cause unnecessary stress 4. Any condition that under judgment of the investigator would make the subject unsuitable as it may interfere with interpretation of study results 5. Currently using any compound recognised as acting as a light sensitizer / has a recognised condition associated with light sensitisation / tissue sensitivity to light such as photodynamic therapy or lupus. 6. Is pregnant or breastfeeding 7. Has a laboratory abnormality in medical record that may interfere with the interpretation of study results Inclusion criteria for healthy volunteers 1. Adult aged 18 and older. 2. Willing and able to comply with all study procedures. Exclusion criteria for healthy volunteers 1. Has a medical condition for which biopsy has been indicated or is undergoing inspection for early cancer. 2. Severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy and any other immunosuppression / immuno-modulation therapy. 3. Has other severe acute or chronic medical or psychiatric condition where use of the device may cause unnecessary stress 4. Any condition that under judgment of the investigator would make the subject unsuitable as it may interfere with interpretation of study results 5. Currently using any compound recognised as acting as a light sensitizer / has a recognised condition associated with light sensitisation / tissue sensitivity to light such as photodynamic therapy or lupus. 6. Is pregnant or breastfeeding