Oral Cancer Screening and Education in Hong Kong

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04487938

Collaborator

(none)

3,190

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will be conducted to obtain data on oral cancer risk factors to generate machine learning models with good predictive accuracy for stratifying individuals with high-oral cancer risk and delineating high-risk and low-risk oral lesions. Likewise, this study will seek to provide oral cancer-related health education and training on oral-self-examination for beneficiaries

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer Oral Leukoplakia Oral Submucous Fibrosis Proliferative Verrucous Leukoplakia Oral Erythroplakia Erosive Lichen Planus	Other: No intervention utilised

Study Design

Study Type:

Observational

Anticipated Enrollment :

3190 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

THE HONG KONG ORAL CANCER EDUCATION AND SCREENING (HOCES) PROGRAM: REFINING DISEASE PREVENTION, RISK STRATIFICATION AND EARLY DETECTION

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Tobacco use and/or alcohol consumption	Other: No intervention utilised No intervention utilised
No tobacco use and/or alcohol consumption	Other: No intervention utilised No intervention utilised

Arm

Intervention/Treatment

Tobacco use and/or alcohol consumption

Other: No intervention utilised

No intervention utilised

No tobacco use and/or alcohol consumption

Other: No intervention utilised

No intervention utilised

Outcome Measures

Primary Outcome Measures

Accuracy of machine learning algorithms for predicting high-risk persons [24 months]
Predictive accuracy of the ML classifiers for forecasting individuals with or likely to develop high-risk lesions within 24 months of first screening encounter based on demographic and lifestyle information.
Accuracy of machine learning algorithms for discriminating high-risk and low-risk lesions [24 months]
Predictive accuracy of ML classifiers for classifying high-risk and low-risk lesions based on demographic and lifestyle risk factors, oral high-risk HPV status, and salivary DNA hypermethylation levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy individuals satisfying age and residential area criteria with no previous history of oral cancer. Individuals with a history of other cancers will be included in the study provided they have been in remission for more than three years.

Exclusion Criteria:

Participants with reduced mouth opening (irrespective of the cause) to permit proper administration of VOE or photosensitive epilepsy will be excluded. Likewise, those who decline the provision of written consent or participation in any part of the study.