Oral Cancer Screening and Education in Hong Kong

NCT04487938 | Unknown DMC

• 1 other identifier: thomsonp@hku.hk
• Study Type: observational
• Target: 3,190
• Locations: 0 countries
• Sites: N/A

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

Conditions

Oral Cancer; Oral Leukoplakia; Oral Submucous Fibrosis; Proliferative Verrucous Leukoplakia; Oral Erythroplakia; Erosive Lichen Planus

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Tobacco use and/or alcohol consumption

Other: No intervention utilised

No tobacco use and/or alcohol consumption

Other: No intervention utilised

Interventions

No intervention utilised OTHER

No intervention utilised

No tobacco use and/or alcohol consumption; Tobacco use and/or alcohol consumption

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hong Kong residents aged 45 years and above residing in Southern and Central and Western district council districts (DCD).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Related Publications (4)

• Adeoye J, Choi SW, Thomson P. Bayesian disease mapping and the 'High-Risk' oral cancer population in Hong Kong. J Oral Pathol Med. 2020 Oct;49(9):907-913. doi: 10.1111/jop.13045. Epub 2020 Jun 10.

  PMID: 32450000 BACKGROUND

• Adeoye J, Brennan PA, Thomson P. "Search less, verify more"-Reviewing salivary biomarkers in oral cancer detection. J Oral Pathol Med. 2020 Sep;49(8):711-719. doi: 10.1111/jop.13003. Epub 2020 Mar 5.

  PMID: 32027406 BACKGROUND

• 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. 2022 Apr;37(2):439-448. doi: 10.1007/s13187-020-01834-x.

  PMID: 32705524 BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Oral rinse samples obtained via drooling in 50cc tubes.

MeSH Terms

Conditions

Mouth Neoplasms; Leukoplakia, Oral; Oral Submucous Fibrosis

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Leukoplakia; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Thomson

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Adeoye

CONTACT

56441784; jaadeoye@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: August 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share