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Clinical Trials/NCT05762991
NCT05762991
Recruiting
Not Applicable

Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Multihospital Study

National Taiwan University Hospital1 site in 1 country2,000 target enrollmentDecember 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Helicobacter Pylori Infection
Sponsor
National Taiwan University Hospital
Enrollment
2000
Locations
1
Primary Endpoint
Sensitivity to detect premalignant gastric lesions
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

The aim of this diagnostic accuracy study is to evaluate the application of artificial intelligence on the diagnosis of Helicobacter pylori infection and premalignant gastric lesions based on upper endoscopic images. We use techniques of artificial intelligence to analyze the correlation between endoscopic images and urea breath test results/histopathological results.

Detailed Description

This study had invited patients to undergo urea breath test, upper gastrointestinal endoscopy, and histology examination. The study will collect their tests results, upper gastrointestinal endoscopy images, and histopathological results. Artificial intelligence techniques will be used to analyze the correlation between endoscopic images and urea breath test results/histopathological results. We aim to establish a telemedicine system to assist clinicians in diagnosing Helicobacter pylori infection and detecting premalignant gastric lesion using upper endoscopic images. The system will be implemented as a telemedicine service system in the rural areas, for example Matsu Islands. The baseline histological predictions will be linked to the newly incident gastric cancer.

Registry
clinicaltrials.gov
Start Date
December 24, 2021
End Date
December 31, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Scheduled urea breath test and endoscopy

Exclusion Criteria

  • History of gastric surgery

Outcomes

Primary Outcomes

Sensitivity to detect premalignant gastric lesions

Time Frame: Up to 5 years

Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection

Secondary Outcomes

  • Specificity to exclude premalignant gastric conditions(Up to 5 years)

Study Sites (1)

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