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Application and Validation of a Smartphone-based Deep Learning System for Oral Potentially Malignant Disorders and Oral Cancer Screening

NCT06862414 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 954

Last updated 2025-03-06

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if smartphone-based deep learning system works to accurately detect oral potentially malignant disorders and oral cancer in adults. It will also learn about if it is as effective as assessments conducted by dentists and non-certified health provider.

We expect that the deep learning system will have higher sensitivity in detecting oral potentially malignant disorders and oral cancer, where as the dentists and non-certified health providers will exhibit higher specificity in screening.

Participants will be grouped into three arms: deep learning system (arm A) or board-certified dentist with deep learning system (arm B) or non-certified health providers (general practitioners) with deep learning system (arm C).

Oral cancer risk factors, such as habits of smoking or having chewed betel nut or alcohol drinking, would be recorded by anonymous questionnaires.

Conditions

  • Cancer Screening
  • Oral Cancer
  • Oral Potentially Malignant Disorders

Interventions

DEVICE

Smartphone-based deep learning system

The smartphone-based deep learning system was trained using a dataset of over 50,000 white-light macroscopic images collected between 2006 and 2013 to develop the YOLOv7 model. Lesions were categorized into three referral grades: benign (green), potentially malignant (yellow), and malignant (red).

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Shao-Yi Cheng, MD, MSc, DrPH · Department of Family Medicine, College of Medicine and Hospital, National Taiwan University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862414 on ClinicalTrials.gov