Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis

Gastric Cancer Clinical Trial

— GIMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840056
• Other study ID #: 2021.082
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Felix Sia
• Phone: +85226370428
• Email: felix.sia[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• none

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastric Cancer
• Gastritis
• Gastritis, Atrophic
• Intestinal Metaplasia
• Metaplasia
• Stomach Neoplasms

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric cancer and gastric dysplasia	The primary endpoint is the incidence of gastric cancer (intestinal-type) and gastric dysplasia (low grade and high grade dysplasia).	20 years
Secondary	Overall accuracy of machine learning model	Overall accuracy of machine learning models will be evaluated	20 years
Secondary	Sensitivity of machine learning model	Sensitivity of machine learning model will be evaluated	20 years
Secondary	Specificity of machine learning model	Specificity of machine learning model will be evaluated	20 years
Secondary	Positive predictive value of machine learning model	Positive predictive value of machine learning model will be evaluated	20 years
Secondary	Negative predictive value of machine learning model	Negative predictive value of machine learning model will be evaluated	20 years
Secondary	Area under the receiver operating characteristic curve of machine learning model	Area under the receiver operating characteristic curve of machine learning model will be evaluated	20 years