ClinicalTrials.gg
Status unknownNCT04487938Updated Jul 27, 2020

Oral Cancer Screening and Education in Hong Kong

An observational study in Oral Cancer, Oral Leukoplakia and Oral Submucous Fibrosis, sponsored by The University of Hong Kong. Status unknown. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-27.

Primary conditionLeukoplakia, OralRegistry: Mouth NeoplasmsReclassifiedWhy we changed it
Registry
Mouth Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Leukoplakia, Oral
Why
  1. The study's listed conditions name Leukoplakia, Oral, a narrower term within Mouth Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The University of Hong Kong · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,190
Ages
45 Years and older
Sex
All
01

Study 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

02

Conditions studied

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

Browse trials for

03

In context

Leukoplakia, Oral Reclassified

48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.

This study's planned enrollment of 3,190 is above the median of 97 across 20 observational studies indexed under Leukoplakia, Oral.

Browse Leukoplakia, Oral studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Leukoplakia, Oral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mouth Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,190 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Tobacco use and/or alcohol consumption

    Other: No intervention utilised

  • No tobacco use and/or alcohol consumption

    Other: No intervention utilised

Interventions

  • OtherNo intervention utilised

    No intervention utilised

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32450000 ↗
  • 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. PubMed 32027406 ↗
  • 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. PubMed 32705524 ↗
  • Adeoye J, Thomson P. Strategies to improve diagnosis and risk assessment for oral cancer patients. Faculty Dental Journal. 2020;11(3):122-7.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2021; primary completion for Jul 2023, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2020
First posted
Jul 27, 2020
StartEst.
Aug 1, 2021
Primary completionEst.
Jul 31, 2023
CompletionEst.
Jul 31, 2024
Last update
Jul 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04487938
Responsible party
Professor Peter James Thomson (Professor, The University of Hong Kong) — Principal investigator
First posted
Jul 27, 2020
Start date
Aug 1, 2021 (estimated)
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Jul 27, 2020

Study contacts

John Adeoye
Contact
jaadeoye@hku.hk
56441784
Peter Thomson
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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