Real-time Molecular Diagnosis of Oral Precancer

NCT07110623 | Not Yet Recruiting

• 1 other identifier: 307234
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Cancer; Dysplasia; Oral Lesions; Oral Pre-cancer; Mouth Cancer

Keywords

oral cancer; mouth lesions; dysplastic oral lesions; mouth cancer; pre-cancer; mouth pre-cancer; oral pre-cancer; oral lesions; oral biopsy; polarized Raman spectroscopy

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the collection of spectra from the oral cavity of each participant, including premalignant, malignant lesions and benign tissues within the same individuals.

  Spectra outputs from the device will be collected from the device computer and matched to biopsy results for patients enrolling in the study. For healthy controls, spectra will be collected and assigned as being scanned from healthy tissue.

  Day 1

Secondary Outcomes (3)

• Pilot safety data collected through adverse events monitoring

  From the point of scan up to 24 hours after the device scan

• Participant feedback about having a scan with the LIP device using bespoke questionnaire

  Day 1

• User acceptability and feedback about the LIP device using bespoke questionnaire

  Day 1

Study Arms (2)

Patient group

1. Has a medical condition for which biopsy of oral tissue has been indicated. 2. Is undergoing inspection for early oral cancer

Device: LIP device

Healthy controls

Participants who have healthy oral tissue

Device: LIP device

Interventions

LIP device DEVICE

The LIP device uses polarized Raman spectroscopy to enhance the early detection and diagnosis of oral cancer by facilitating more accurate guiding of biopsies. This non-invasive technology utilizes polarized laser light to generate Raman scattering that can be used to analyze molecular vibrations, which in the future will provide clinicians with insights into tissue composition and structure for identifying cancerous abnormalities.

Healthy controls; Patient group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a single site at Guy's Hospital (London, UK). Patients with suspected pre-malignant or malignant condition (ie. having a "suspicious lesion") will be recruited from oral medicine and dental clinics at Guy's Hospital (London, UK) during their hospital appointment. Healthy volunteers will be recruited from staff and students at KCL and GSTT.

You may qualify if:

• Adult aged 18 and older
• One of the following criteria must be met:
• Has a medical condition for which biopsy of oral tissue has been indicated.
• Is undergoing inspection for early oral cancer
• Willing and able to comply with all study procedures.

You may not qualify if:

• Has a bleeding disorder, such as haemophilia, or has contraindication for having a biopsy.
• 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.
• Has other severe acute or chronic medical or psychiatric condition where use of the device may cause unnecessary stress
• Any condition that under judgment of the investigator would make the subject unsuitable as it may interfere with interpretation of study results
• 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.
• Is pregnant or breastfeeding
• Has a laboratory abnormality in medical record that may interfere with the interpretation of study results
• Adult aged 18 and older.
• Willing and able to comply with all study procedures.
• Has a medical condition for which biopsy has been indicated or is undergoing inspection for early cancer.
• 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.
• Has other severe acute or chronic medical or psychiatric condition where use of the device may cause unnecessary stress
• Any condition that under judgment of the investigator would make the subject unsuitable as it may interfere with interpretation of study results
• 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.
• Is pregnant or breastfeeding

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Oral Clinical Research Unit, Guy's Hospital

London, Surrey, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mads Bergholt, PhD

  King's College London

  STUDY CHAIR

• Richard J Cook, PhD, MRCSEd, MBChB, FDS RCS

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Wojewodka, PhD

CONTACT

+44 020 7848 5958; FoDOCS-researchsupport@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 7, 2025
• Study Start: September 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)