ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001122347

Ethics application status

Approved

Date submitted

10/06/2026

Date registered

9/09/2026

Date last updated

9/09/2026

Date data sharing statement initially provided

9/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Non-invasive tools for assessing skin in the mouth

Scientific title

Non-invasive assessment of oral tissues using thermal imaging and molecular biomarkers in adults presenting with oral soft tissue diseases

Additional trial identifiers [1]

UoM Clinical Trial 32426

Additional trial identifiers [2]

CT-2026-CTN-01402-1

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

oral cancer

oral potentially malignant disorders

oral precancer

oral dysplasia

periodontitis

oral lichen planus

oral leukoplakia

proliferative verrucous leukoplakia

Condition category

Condition code

Cancer

Head and neck

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Skin

Other skin conditions

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of the intervention or exposure

This observational clinical trial is a cross-sectional study designed to evaluate non-invasive diagnostic tools for early detection of oral cancer in adults with oral mucosal diseases.
Condition Observed
• Target Population: Adults (equal or greater than 18 years) with oral soft tissue diseases, including gingivitis, periodontitis, leukoplakia without dysplasia, oral dysplasia, oral lichenoid lesions, oral lichen planus, or other oral mucosal disorders.
• Clinical Focus: The study observes both cancerous and non-cancerous oral mucosal changes, aiming to distinguish between them using non-invasive methods.
The exposures will be administered by AHPRA registered oral health professional researcher. These procedures are accessed because of enrollment in the study and will otherwise not form part of the patients clinical assessment.
Exposure Details
• Non-Invasive Tools Used:
1. Single-lens Reflex (SLR) Photography: Imaging of lips, buccal mucosae, gingivae, tongue, and palate.
2. Thermal Imaging (ThermOralCam): Captures thermal flux data from intraoral sites to detect abnormal heat signatures associated with cancerous tissue.
3. Oral Swirl: Participants rinse with sterile water for 50 seconds and provide the sample for molecular analysis (microRNA-based risk assessment).
4. Brush Sample: A soft brush collects cells from the lesion surface.
5. Oral Scrape: A dermatological curette collects surface cells from lesions.
• Investigational Product: The study does not administer any drugs or experimental treatments; all exposures are non-invasive sample collections and imaging. The investigational product is the thermal-camera.

The total participation time is up to 20 minutes per patient
SLR photograph (5 minutes) and Thermal imaging (10 minutes) may total 15 minutes and the collection of the oral swirl, brush and scrape may take up to 5 minutes.

The results of these tests will not impact subsequent treatment or clinical recommendations made to participants.

The collection will take in a consulting room or dental surgery room.

Diagnosis will be determined as per standard care and the results from the administered investigational tools (exposure) will be not be available to participants.

Duration of Observation
• Study Timeline: The protocol is planned for 3 years (2026–2029).
• Participant Involvement: Each participant is assessed at a single time point coinciding with their scheduled clinical visit for oral disease management. No further follow-up is required from participants after sample and data collection.
• Recruitment Goal: Up to 150 participants will be enrolled over the 3-year period.

Intervention code [1]

Not applicable

Description of the comparator or control

No control group. This study is an uncontrolled, cross-sectional observational trial without a comparator or control treatment. All participants receive the same non-invasive assessments and sample collections as part of the study protocol.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Presence of Oral Cancer

Timepoint [1]

Single Time Point

Primary outcome [2]

Presence of Oral Cancer

Timepoint [2]

Single time point

Primary outcome [3]

Presence of Oral Cancer

Timepoint [3]

Single Time Point

Secondary outcome [1]

Presence of composite oral potentially malignant disorders or other mucosal diseases

Timepoint [1]

Single Time Point

Secondary outcome [2]

Presence of composite oral potentially malignant disorders or other mucosal diseases

Timepoint [2]

Single Time point

Secondary outcome [3]

Presence of composite oral potentially malignant disorders or other mucosal diseases

Timepoint [3]

Single Time Point

Eligibility

Key inclusion criteria

Individuals with oral soft tissue diseases (e.g., oral cancer gingivitis, periodontitis, leukoplakia without dysplasia, oral dysplasia, oral lichenoid lesions, oral lichen planus, or other oral mucosal disorders)
Age 18 years or older
Presenting for standard oral care including pre-surgery
Able to provide informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

None

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

• The statistical methods include descriptive statistics to summarize participant demographics and clinical characteristics, and comparative analyses such as t-tests, ANOVA, or Mann-Whitney U tests to compare molecular and optical findings between tissue types. Correlation analyses (using Pearson’s or Spearman’s coefficients) will assess relationships between molecular and clinical/optical data, while multivariable regression models may be used to identify predictors and account for confounding variables. All analyses will be performed using R software, with statistical significance set at p < 0.05, and data visualizations (e.g., box plots, histograms, scatter plots) will be used to illustrate key findings. For this explorative study, 150 participants are considered sufficient.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

21/09/2026

Actual

Date of last participant enrolment

Anticipated

21/09/2028

Actual

Date of last data collection

Anticipated

21/09/2028

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Melbourne

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Melbourne - Graeme Clark Institute Seed Grant

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Melbourne Hospital Human Research Ethics Committee

Ethics committee address [1]

https://www.thermh.org.au/research/researchers/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2025

Approval date [1]

23/07/2025

Ethics approval number [1]

Summary

Brief summary

This study aims to assess whether non-invasive methods (imaging and mouth swabs) can detect early signs of oral cancer in people with changes in the soft tissues of their mouth.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an oral soft tissue disease, this may include oral cancer, periodontitis (gum disease), pre-cancerous tissue changes and other oral lesions; and you are undergoing treatment with a doctor or dentist for your condition.

Study details
All participants who choose to enrol in this study will be asked to attend an appointment at your usual treatment location . During the appointment, the dentist will use two types of camera to take regular and heat-sensitive images of the inside and outside of your mouth and will ask you to provide a saliva sample and cheek/tongue swabs for assessment. The appointment should take no more than 20 minutes.  Individual image captures will not be provided to participants.  Your care will continue as usual.   

It is hoped this research will determine whether these non-invasive methods can help doctors and dentists spot oral cancer earlier, which may reduce the need for unnecessary surgeries, and ideally would make the process easier and less stressful for patients.
signs of oral cancer in people with changes in the soft tissues of their mouth. Instead of relying only on traditional biopsies, the study will test new tools—such as special cameras that take regular and heat-sensitive photos, and simple mouth rinse or gentle brush samples—to see if they can accurately identify which mouth changes are at risk of becoming cancer. The main idea is that these new, non-invasive methods can help doctors and dentists spot cancer earlier, reduce the need for unnecessary surgeries, and make the process easier and less stressful for patients. The study's hypothesis is that these non-invasive tools will be just as good, or better, than current methods at telling the difference between harmless and risky mouth changes, leading to earlier and more accurate treatment for those who need it.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Tami Yap

Address

University of Melbourne, Level 5/720 Swanston Street Carlton VIC 3053

Country

Australia

Phone

+61393411485

Fax

[email protected]

Contact person for public queries

Name

Tami Yap

Address

University of Melbourne, Level 5/720 Swanston Street Carlton VIC 3053

Country

Australia

Phone

+61393411485

Fax

[email protected]

Contact person for scientific queries

Name

Tami Yap

Address

University of Melbourne, Level 5/720 Swanston Street Carlton VIC 3053

Country

Australia

Phone

+61393411485

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• Published results

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically