Health TrialsbyHealthPanel

Real-time Molecular Diagnosis of Oral Precancer

ConditionsOral CancerDysplasiaOral LesionsOral Pre-cancerMouth Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKing's College London

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult aged 18 and older

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patient group1 intervention
Group B: Healthy controls1 intervention

Trial outcomes

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.

Time frame
Day 1

Secondary outcomes

1

Pilot safety data collected through adverse events monitoring

Pilot safety data will be collected for study participants and users of the device by recording adverse events from participants after the scan and from device users when using the scan.

Time frame
From the point of scan up to 24 hours after the device scan
2

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

Feedback from study participants will be collected regarding their experience of having an oral scan with the LIP device. The "LIP Feedback Questionnaire for participants" was designed specifically for this study to capture feedback through Likert-type questions and free text boxes. Answers are not reported using a scale.

Time frame
Day 1
3

User acceptability and feedback about the LIP device using bespoke questionnaire

To better understand the experience of users of the device, feedback will be collected on the "LIP Feedback Questionnaire for users of the device" which was created to capture the device user experience with Likert-type questions and free text boxes. Answers are not reported using a scale.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: