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RecruitingNCT04840056GIMAUpdated Sep 22, 2026

Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis

An observational study in Gastric Cancer, Intestinal Metaplasia and Atrophic Gastritis, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,300
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Gastric Cancer
  • Intestinal Metaplasia
  • Atrophic Gastritis

Keywords

  • artificial intelligence
03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

- none

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intestinal Metaplasia

    patient with history of histologically proven gastric intestinal metaplasia

  • Atrophic gastritis

    patient with history of histologically proven atrophic gastritis

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 20 years

Secondary outcomes

  1. Overall accuracy of machine learning model

    Overall accuracy of machine learning models will be evaluated

    Time frame: 20 years

  2. Sensitivity of machine learning model

    Sensitivity of machine learning model will be evaluated

    Time frame: 20 years

  3. Specificity of machine learning model

    Specificity of machine learning model will be evaluated

    Time frame: 20 years

  4. Positive predictive value of machine learning model

    Positive predictive value of machine learning model will be evaluated

    Time frame: 20 years

  5. Negative predictive value of machine learning model

    Negative predictive value of machine learning model will be evaluated

    Time frame: 20 years

  6. 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

    Time frame: 20 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD with other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04840056
Responsible party
Louis Ho Shing Lau (Principal Investigator, Chinese University of Hong Kong) — Principal investigator
First posted
Apr 9, 2021
Start date
Apr 15, 2021
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 22, 2026

Study contacts

Felix Sia
Contact
felix.sia@cuhk.edu.hk
+85226370428
Thomas Lam
Contact
thomas.lam@cuhk.edu.hk
+85226370428

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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