Oral CancerNCT04487938
Oral Cancer Screening and Education in Hong Kong
An observational study of Oral Cancer and Oral Leukoplakia, run by The University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Oral Leukoplakia, Oral Submucous Fibrosis
- How many people
- 3,190 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hong Kong residents aged 45 years and above residing in Southern and Central and Western district council districts (DCD).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: THE HONG KONG ORAL CANCER EDUCATION AND SCREENING (HOCES) PROGRAM: REFINING DISEASE PREVENTION, RISK STRATIFICATION AND EARLY DETECTION
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
- Being tested
- No intervention utilised
- Medical subject headings
- Mouth Neoplasms, Leukoplakia, Oral, Oral Submucous Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention utilisedOther
No intervention utilised
| Study group | Role | What they receive |
|---|---|---|
| Tobacco use and/or alcohol consumption | Not described Receives: Other: No intervention utilised | |
| No tobacco use and/or alcohol consumption | Not described Receives: Other: No intervention utilised |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Aug 2021 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Peter James Thomson, The University of Hong Kong
- Investigators
- Peter Thomson, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487938
- Sponsor's protocol ID
- thomsonp@hku.hk
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32450000Adeoye 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 32027406Adeoye 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 32705524Adeoye J, Thomson P. Strategies to improve diagnosis and risk assessment for oral cancer patients. Faculty Dental Journal. 2020;11(3):122-7.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE HONG KONG ORAL CANCER EDUCATION AND SCREENING (HOCES) PROGRAM: REFINING DISEASE PREVENTION, RISK STRATIFICATION AND EARLY DETECTION
- ClinicalTrials.gov ID
- NCT04487938
- Acronym / sponsor ID
- thomsonp@hku.hk
- Conditions
- Oral Cancer, Oral Leukoplakia, Oral Submucous Fibrosis, Proliferative Verrucous Leukoplakia, Oral Erythroplakia, Erosive Lichen Planus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,190 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco use and/or alcohol consumption | – | Other: No intervention utilised |
| No tobacco use and/or alcohol consumption | – | Other: No intervention utilised |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hong Kong residents aged 45 years and above residing in Southern and Central and Western district council districts (DCD).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention utilisedNo intervention utilised | Other | No tobacco use and/or alcohol consumption, Tobacco use and/or alcohol consumption |
Primary outcome
Accuracy of machine learning algorithms for predicting high-risk persons
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 32450000Adeoye 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.
- Background: PubMed 32027406Adeoye 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.
- Background: PubMed 32705524Adeoye 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.
- BackgroundAdeoye J, Thomson P. Strategies to improve diagnosis and risk assessment for oral cancer patients. Faculty Dental Journal. 2020;11(3):122-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Thomson principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer and Oral Leukoplakia, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Adeoye (56441784, jaadeoye@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of machine learning algorithms for predicting high-risk persons (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487938, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.