Oral Cancer Screening and Education in Hong Kong

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04487938
• Other study ID #: thomsonp@hku.hk
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2020
• Source: The University of Hong Kong
• Contact: John Adeoye
• Phone: 56441784
• Email: jaadeoye[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3190
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erosive Lichen Planus
• Leukoplakia
• Leukoplakia, Oral
• Lichen Planus
• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Oral Erythroplakia
• Oral Leukoplakia
• Oral Submucous Fibrosis
• Proliferative Verrucous Leukoplakia

Intervention

Other:
• No intervention utilised
No intervention utilised

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

References & Publications (4)

Adeoye J, Brennan PA, Thomson P. "Search less, verify more"-Reviewing salivary biomarkers in oral cancer detection. J Oral Pathol Med. 2020 Feb 6. doi: 10.1111/jop.13003. [Epub ahead of print] Review. — View Citation

Adeoye J, Choi SW, Thomson P. Bayesian disease mapping and the 'High-Risk' oral cancer population in Hong Kong. J Oral Pathol Med. 2020 May 25. doi: 10.1111/jop.13045. [Epub ahead of print] — View Citation

Adeoye J, Chu CS, Choi SW, Thomson P. Oral cancer awareness and individuals' inclination to its screening and risk prediction in Hong Kong. J Cancer Educ. 2020.

Adeoye J, Thomson P. Strategies to improve diagnosis and risk assessment for oral cancer patients. Faculty Dental Journal. 2020;11(3):122-7.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of machine learning algorithms for predicting high-risk persons	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.	24 months
Primary	Accuracy of machine learning algorithms for discriminating high-risk and low-risk lesions	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.	24 months