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Smartphone Deep Learning System for Oral Cancer Screening

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What is being tested

Smartphone-based deep learning system

Device
Who is being recruted

Head and Neck Neoplasms+3

+ Stomatognathic Diseases

+ Mouth Diseases

Over 19 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Study ContactShao-Yi Cheng, MD, MSc, DrPHMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

Oral cancer is a major health concern in Taiwan and around the world, causing many deaths each year. This study aims to test a new smartphone-based system that uses artificial intelligence (AI) to help detect early signs of oral cancer and disorders that might become cancerous. The goal is to see if this system can work as well as examinations by dentists and other health providers. This is important because early detection can lead to better treatment outcomes and the AI system might make it easier for people to get screened, even in areas with fewer healthcare providers. The study takes place in a medical center in Northern Taiwan and involves adults visiting for cancer screenings. Participants are divided into three groups, each receiving different types of screening: one with just the AI system, another with the AI plus a dentist, and the third with the AI plus a general health provider. The AI system categorizes the results into three groups: benign, potentially malignant, or malignant. Researchers will measure how accurately each method identifies these categories and how comfortable participants feel during the process. This study could show whether the AI system is a reliable tool for early detection of oral cancer.

Official TitleApplication and Validation of a Smartphone-based Deep Learning System for Oral Potentially Malignant Disorders (OPMD) and Oral Cancer Screening
NCT06862414
Principal SponsorNational Taiwan University Hospital
Study ContactShao-Yi Cheng, MD, MSc, DrPHMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

954 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasmsNeoplasms by Site

Criteria

1 inclusion criteria required to participate
Adult patients (age ≥18) visiting cancer screening center

2 exclusion criteria prevent from participating
Unable to cooperate to fully open mouth/ navigate tongue

Unable to cooperate for the assessment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Deep learning system

Group II

Active Comparator
Board-certified dentist with deep learning system

Group III

Active Comparator
non-certified health providers (general practitioners) with deep learning system

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Family Medicine, National Taiwan University Hospital

Taipei, TaiwanOpen Department of Family Medicine, National Taiwan University Hospital in Google Maps
Recruiting soonOne Study Center