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Clinical Trials/NCT04840056
NCT04840056
Recruiting
Not Applicable

Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis - Application of Artificial Intelligence in Histology and Clinical Data

Chinese University of Hong Kong1 site in 1 country1,300 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
1300
Locations
1
Primary Endpoint
Gastric cancer and gastric dysplasia
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The primary objectives of this study are:

  • To identify clinical or histological factors associated with gastric cancer development in patients with IM and AG
  • To establish a machine learning algorithm for prediction of future gastric cancer risks and individual risk stratification in patient with IM and AG

Detailed Description

This is a two-part retrospective study including a clinical data part and a pathology part. A training cohort will be developed from approximately 70% of included cases. It will be followed by a validation cohort with the remaining cases. Clinical data will be collected retrospectively using the Clinical Data Analysis and Reporting System (CDARS) and Clinical management System (CMS). A cluster-wide cohort (New Territories East Cluster, NTEC) consisting of patients with history of histologically-proven gastric IM and AG will be identified and included for subsequent analysis. The data collection period for the retrospective data will be 2000-2020. Histology slides will be retrieved retrospectively when available (within NTEC). Whole slide imaging technique will be utilized for the development of training and validation cohorts with machine learning algorithms in the pathology part.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Louis Ho Shing Lau

Principal Investigator

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Adults \>= 18 years of age
  • Histologically proven atrophic gastritis or intestinal metaplasia (at antrum and/or body and/or angular of stomach)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gastric cancer and gastric dysplasia

Time Frame: 20 years

The primary endpoint is the incidence of gastric cancer (intestinal-type) and gastric dysplasia (low grade and high grade dysplasia).

Secondary Outcomes

  • Negative predictive value of machine learning model(20 years)
  • Overall accuracy of machine learning model(20 years)
  • Sensitivity of machine learning model(20 years)
  • Specificity of machine learning model(20 years)
  • Positive predictive value of machine learning model(20 years)
  • Area under the receiver operating characteristic curve of machine learning model(20 years)

Study Sites (1)

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