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Oral Cancer Screening and Education in Hong Kong

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ClinicalTrials.gov Identifier: NCT04487938
Recruitment Status : Not yet recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Peter James Thomson, The University of Hong Kong

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
Oral Cancer Oral Leukoplakia Oral Submucous Fibrosis Proliferative Verrucous Leukoplakia Oral Erythroplakia Erosive Lichen Planus Other: No intervention utilised

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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024


Group/Cohort 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




Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
Oral rinse samples obtained via drooling in 50cc tubes.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487938


Contacts
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Contact: John Adeoye 56441784 jaadeoye@hku.hk

Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Peter Thomson The University of Hong Kong
Publications:
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Responsible Party: Professor Peter James Thomson, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04487938    
Other Study ID Numbers: thomsonp@hku.hk
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth Neoplasms
Lip Neoplasms
Leukoplakia
Leukoplakia, Oral
Oral Submucous Fibrosis
Lichen Planus
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Precancerous Conditions
Pathological Conditions, Anatomical