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NCT06862414
NA

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

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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.

Official title: Application and Validation of a Smartphone-based Deep Learning System for Oral Potentially Malignant Disorders (OPMD) and Oral Cancer Screening

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

954

Start Date

2025-03

Completion Date

2025-12

Last Updated

2025-03-06

Healthy Volunteers

Yes

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).

Locations (1)

Department of Family Medicine, National Taiwan University Hospital

Taipei, Taiwan