Not yet recruitingOBSERVATIONAL

Real-time Molecular Diagnosis of Oral Precancer

The LIP study is exploring a new way to spot mouth cancer early, which is crucial for better treatment. Currently, mouth cancer is diagnosed by taking a small tissue sample (biopsy) and examining it in a lab. Doctors and dentists look for suspicious areas, but it can be hard to see the very first signs of cancer. This new device uses a laser beam to scan inside the mouth, and a computer then analyses this information. The study aims to teach the computer to recognise early cancer or pre-cancerous areas. It will involve scanning patients who are already having a biopsy and healthy volunteers to help the device learn to tell the difference between normal and abnormal tissue. The goal is a quicker, less invasive way to diagnose mouth cancer.

At a glance

Status

Not yet recruiting

Sponsor

King's College London

Enrolment target

Start

01 Sep 2025

Estimated completion

31 Oct 2025

Oral Cancer Dysplasia Oral Lesions Oral Pre-cancer Mouth Cancer

What is this study about?

Mouth cancers are serious conditions, and finding them as early as possible significantly improves the chances of successful treatment. Currently, the main way to diagnose mouth cancer is by taking a biopsy. This means a doctor or dentist removes a small piece of tissue from a suspicious area in the mouth for examination under a microscope. While effective, this method relies heavily on the doctor's ability to spot problem areas, and it can be difficult to find very early signs of cancer.

This study, called the LIP study, is looking at a new device that could make early detection much easier and potentially less invasive. The device works by using a laser beam to scan the inside of your mouth. A computer then gathers information from this scan. The main purpose of this study is to 'teach' this computer software to recognise the scans that indicate pre-cancerous cells or actual cancer, distinguishing them from healthy tissue.

To do this, the study will involve two groups. Patients who are already scheduled to have a biopsy because their doctor suspects pre-cancer or cancer will be scanned with the device. The results from their biopsy will then be used to show the computer software what pre-cancer, cancer, and non-cancerous tissues look like in its scans. Additionally, healthy volunteers will also be scanned to help the computer software learn what normal, healthy mouth tissue looks like. If this initial study is successful, it could lead to larger trials and eventually a new, faster, and non-invasive way to diagnose mouth cancer.

Key takeaways

This study is testing a new laser scanning device to find mouth cancer early.
Early detection of mouth cancer is vital for better treatment success.
The device aims to replace or improve on traditional biopsies, which can be invasive.
It involves teaching computer software to recognise cancer and pre-cancer from scans.
You could help advance medical science without direct personal medical benefit from the device.
Participation includes a non-invasive mouth scan, and is considered low risk.

Who may be eligible?

This study is looking for two groups of participants: patients who might have mouth cancer or pre-cancerous changes, and healthy volunteers.

Patients can join if they are aged 18 or over and are already due to have a biopsy because their doctor suspects mouth cancer or pre-cancer. They must also be willing to follow all the study's instructions. Patients cannot take part if they have a bleeding disorder, severe long-term illnesses like advanced kidney or heart failure, or certain conditions that affect how their body reacts to light (like having photodynamic therapy or lupus). Pregnancy or breastfeeding also means you can't join this part of the study.

Healthy volunteers can join if they are 18 or over and are willing to follow all study instructions. They should not have any suspected mouth cancer or pre-cancerous changes, or any of the severe long-term illnesses mentioned above. They also cannot be pregnant or breastfeeding.

Quick self-check

Are you aged 18 or over?
Are you scheduled for a mouth biopsy due to suspected pre-cancer or cancer (for patient group)?
Are you generally healthy and not suspected of having mouth cancer (for healthy volunteer group)?
Are you not pregnant or breastfeeding?
Do you not have a severe long-term illness (like severe kidney or heart failure) or a bleeding disorder?
Do you not have a condition that makes you sensitive to light (e.g., lupus or current photodynamic therapy)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you will have your mouth scanned using the new laser device. This is a non-invasive procedure, meaning it doesn't involve needles or cutting. For patients, this scan will happen before your planned biopsy. For healthy volunteers, it will be the main part of your involvement. The device uses a laser beam to collect information about your mouth tissue. There's no specific medication involved in this study. The researchers will also collect feedback from you about your experience with the device. The total duration of your participation will likely be short, involving just one or two appointments for the scan and any follow-up discussions.

Potential risks and benefits

A potential benefit of joining this study is contributing to the development of a new tool that could help diagnose mouth cancer earlier and more easily in the future, which could improve outcomes for many patients. As this is still an early-stage study, there are no direct medical benefits to you personally, as the device is not yet used for diagnosis. The risks involved are expected to be minimal, as the laser used is considered safe and non-ionising. You will have full rights to withdraw from the study at any time without affecting your medical care.

Locations (1)

Oral Clinical Research Unit, Guy's Hospital
London, United Kingdom

Common questions

What is 'oral precancer'?

Oral precancer refers to changes in the cells in your mouth that are not yet cancer but could become cancer over time. Detecting these changes early is very important.

Is the laser device safe?

Yes, the device uses a safe type of laser light. It's non-ionising, meaning it doesn't use radiation like X-rays, and is designed to collect information without causing harm.

Will this device diagnose my condition during the study?

No, this study is about teaching the computer software. Your medical diagnosis will still rely on your doctor's assessment and biopsy results, not the device.

What happens to the information collected from my scan?

The information from your scan helps the computer software learn to identify different types of tissue. Your personal data will be kept confidential.

Will I need to change any of my medications if I take part?

No, there are no medication changes required for this study. However, certain medications and health conditions might mean you can't participate, so discuss this with the study team.

How to find out more

Gabriella Wojewodka, PhD

FoDOCS-researchsupport@kcl.ac.uk +44 020 7848 5958 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.