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NCT05762991 Clinical Trial

Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05762991
Other study ID # 202111108RINC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 24, 2021
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source National Taiwan University Hospital
Contact Yi-Chia Lee, MD, PhD
Phone 886-2-23123456
Email yichialee@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age 20-80 2. Scheduled urea breath test and endoscopy Exclusion Criteria: 1. History of gastric surgery

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Yi-Chia Lee Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other Areas under the ROC curves Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection Up to 5 years
Other Gastric cancer incidence New incident gastric cancer Up to 10 years
Primary Sensitivity to detect premalignant gastric lesions Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection Up to 5 years
Secondary Specificity to exclude premalignant gastric conditions Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection Up to 5 years
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