Gastric CancerGIMANCT04840056
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis
An observational study of Gastric Cancer and Intestinal Metaplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Intestinal Metaplasia, Atrophic Gastritis
- How many people
- 1,300 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adults >= 18 years of age
- Histologically proven atrophic gastritis or intestinal metaplasia (at antrum and/or body and/or angular of stomach)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
About this study
Official title: Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis - Application of Artificial Intelligence in Histology and Clinical Data
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.
- Conditions
- Gastric Cancer, Intestinal Metaplasia, Atrophic Gastritis
- Keywords
- artificial intelligence
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intestinal Metaplasia | patient with history of histologically proven gastric intestinal metaplasia | |
| Atrophic gastritis | patient with history of histologically proven atrophic gastritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 years
Secondary outcomes (6)
Overall accuracy of machine learning model
Overall accuracy of machine learning models will be evaluated
Measured: 20 years
Sensitivity of machine learning model
Sensitivity of machine learning model will be evaluated
Measured: 20 years
Specificity of machine learning model
Specificity of machine learning model will be evaluated
Measured: 20 years
Positive predictive value of machine learning model
Positive predictive value of machine learning model will be evaluated
Measured: 20 years
Negative predictive value of machine learning model
Negative predictive value of machine learning model will be evaluated
Measured: 20 years
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
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Apr 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840056
- Sponsor's protocol ID
- 2021.082
- Acronym
- GIMA
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis - Application of Artificial Intelligence in Histology and Clinical Data
- ClinicalTrials.gov ID
- NCT04840056
- Acronym / sponsor ID
- GIMA / 2021.082
- Conditions
- Gastric Cancer, Intestinal Metaplasia, Atrophic Gastritis
- Keywords
- artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intestinal Metaplasia | – | –patient with history of histologically proven gastric intestinal metaplasia |
| Atrophic gastritis | – | –patient with history of histologically proven atrophic gastritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults >= 18 years of age
- Histologically proven atrophic gastritis or intestinal metaplasia (at antrum and/or body and/or angular of stomach)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Overall accuracy of machine learning model
Time frame: 20 years
Sensitivity of machine learning model
Time frame: 20 years
Specificity of machine learning model
Time frame: 20 years
Positive predictive value of machine learning model
Time frame: 20 years
Negative predictive value of machine learning model
Time frame: 20 years
Area under the receiver operating characteristic curve of machine learning model
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Intestinal Metaplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Sia (+85226370428, felix.sia@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric cancer and gastric dysplasia (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.