Gastric Intestinal MetaplasiaNCT07915843
Multi-center Prospective Validation of Real-Time AI-EGGIM System
An observational study of Gastric Intestinal Metaplasia, run by Qilu Hospital of Shandong University at 3 sites in China.
Trial summary
Gastric intestinal metaplasia (GIM) is a precancerous condition associated with an increased risk of gastric cancer. The endoscopic grading of gastric intestinal metaplasia (EGGIM) score evaluates the extent of GIM across five standard gastric regions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- AI-EGGIM Assessment
- How many people
- 540 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2026to 31 Dec 2027
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Consecutive patients undergoing upper gastrointestinal endoscopy who are screened to fulfill the eligibility criteria will be enrolled in the study.
Who may be able to join
- patients undergoing upper gastrointestinal endoscopy who met at least one of the following criteria: (i) aged 40-75 years; or (ii) had a history of H. pylori infection and/or known premalignant gastric lesions (e.g., atrophic gastritis and IM)
- patients who voluntarily sign the informed consent form
Who cannot join
- patients with severe cardiac, cerebral, pulmonary, or renal dysfunction or psychiatric disorders who cannot receive upper gastrointestinal endoscopy
- patients with previous surgical procedures on the stomach
- patients with upper gastrointestinal cancer
- patients with contraindication to gastric mucosal biopsy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Shandong Medical and Pharmaceutical University Hospital
Binzhou, Shandong, 256603
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Zhen Li, +86-18560086106, qilulizhen@sdu.edu.cn
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, 266035
About this study
Official title: Prospective Multi-center Validation of a Real-Time Artificial Intelligence-Assisted EGGIM System for Gastric Cancer Stratification
Gastric intestinal metaplasia (GIM) is a precancerous condition associated with an increased risk of gastric cancer. The endoscopic grading of gastric intestinal metaplasia (EGGIM) score evaluates the extent of GIM across five standard gastric regions. The investigators developed a real-time artificial intelligence-assisted EGGIM (AI-EGGIM) system that automatically assigns an intestinal metaplasia grade to each region and calculates a total EGGIM score.
This prospective multi-center validation study will consecutively enroll patients undergoing upper gastrointestinal endoscopy. The AI-EGGIM system will generate real-time grades for the five standard gastric regions. Regardless of endoscopic appearance or AI output, every patient will undergo five mapping biopsies, with one biopsy obtained from each standard region. Histopathological operative link on gastric intestinal metaplasia (OLGIM) staging will serve as the reference standard. The primary objective is to estimate the performance of an AI-EGGIM score ≥ 5 for identifying patients at high risk of gastric cancer.
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- AI-EGGIM Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-EGGIM AssessmentDiagnostic test
During image-enhanced endoscopy, the AI-EGGIM system will assign grades of 0, 1, or 2 to each of five standard gastric regions and calculate a total score from 0 to 10.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer
Sensitivity will be calculated as the proportion of participants with histopathologically confirmed OLGIM stages III/IV who have an AI-EGGIM score ≥ 5: true positives divided by the sum of true positives and false negatives.
Measured: From the endoscopy examination to completion of histopathological assessment, up to 14 days
Secondary outcomes (2)
Specificity, Accuracy, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer
Specificity will be calculated as the proportion of patients without histopathologically confirmed OLGIM stages III/IV who have an AI-EGGIM score < 5: true negatives divided by the sum of true negatives and false positives. Accuracy will be calculated as the sum of true positives and true negatives divided by the total number of patients. Positive predictive value will be calculated as true positives divided by the sum of true positives and false positives. Negative predictive value will be calculated as true negatives divided by the sum of true negatives and false negatives. The area under the receiver operating characteristic curve (AUC) will be estimated using AI-EGGIM scores against OLGIM stages III/IV.
Measured: From the endoscopy examination to completion of histopathological assessment, up to 14 days
Correlation and Association of AI-EGGIM Score with OLGIM Stage and Kimura-Takemoto Classification
The correlation of AI-EGGIM score (0-10) with histopathological OLGIM stage (0-IV) and with the ordered Kimura-Takemoto classification will be assessed using Spearman's rank correlation coefficient. In addition, unadjusted and adjusted odds ratios with 95% confidence intervals will be estimated for the associations of AI-EGGIM score ≥5 with OLGIM stages III/IV and with Kimura-Takemoto open-type atrophy (O1-O3).
Measured: From the endoscopy examination to completion of histopathological assessment, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Medical and Pharmaceutical University Hospital, Qilu Hospital of Shandong University (Qingdao)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915843
- Sponsor's protocol ID
- 2026SDU-QILU-8
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Validation of a Real-Time Artificial Intelligence-Assisted EGGIM System for Gastric Cancer Stratification
- ClinicalTrials.gov ID
- NCT07915843
- Acronym / sponsor ID
- 2026SDU-QILU-8
- Conditions
- Gastric Intestinal Metaplasia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Medical and Pharmaceutical University Hospital, Qilu Hospital of Shandong University (Qingdao)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
Gastric intestinal metaplasia (GIM) is a precancerous condition associated with an increased risk of gastric cancer. The endoscopic grading of gastric intestinal metaplasia (EGGIM) score evaluates the extent of GIM across five standard gastric regions. The investigators developed a real-time artificial intelligence-assisted EGGIM (AI-EGGIM) system that automatically assigns an intestinal metaplasia grade to each region and calculates a total EGGIM score.
This prospective multi-center validation study will consecutively enroll patients undergoing upper gastrointestinal endoscopy. The AI-EGGIM system will generate real-time grades for the five standard gastric regions. Regardless of endoscopic appearance or AI output, every patient will undergo five mapping biopsies, with one biopsy obtained from each standard region. Histopathological operative link on gastric intestinal metaplasia (OLGIM) staging will serve as the reference standard. The primary objective is to estimate the performance of an AI-EGGIM score ≥ 5 for identifying patients at high risk of gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients undergoing upper gastrointestinal endoscopy who are screened to fulfill the eligibility criteria will be enrolled in the study.
Key inclusion criteria (2 listed)
- patients undergoing upper gastrointestinal endoscopy who met at least one of the following criteria: (i) aged 40-75 years; or (ii) had a history of H. pylori infection and/or known premalignant gastric lesions (e.g., atrophic gastritis and IM)
- patients who voluntarily sign the informed consent form
Key exclusion criteria (4 listed)
- patients with severe cardiac, cerebral, pulmonary, or renal dysfunction or psychiatric disorders who cannot receive upper gastrointestinal endoscopy
- patients with previous surgical procedures on the stomach
- patients with upper gastrointestinal cancer
- patients with contraindication to gastric mucosal biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-EGGIM AssessmentDuring image-enhanced endoscopy, the AI-EGGIM system will assign grades of 0, 1, or 2 to each of five standard gastric regions and calculate a total score from 0 to 10. | Diagnostic test | – |
Primary outcome
Sensitivity of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer
Time frame: From the endoscopy examination to completion of histopathological assessment, up to 14 days
Sensitivity will be calculated as the proportion of participants with histopathologically confirmed OLGIM stages III/IV who have an AI-EGGIM score ≥ 5: true positives divided by the sum of true positives and false negatives.
2 secondary outcomes
Specificity, Accuracy, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer
Time frame: From the endoscopy examination to completion of histopathological assessment, up to 14 days
Correlation and Association of AI-EGGIM Score with OLGIM Stage and Kimura-Takemoto Classification
Time frame: From the endoscopy examination to completion of histopathological assessment, up to 14 days
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 4 Nov 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Intestinal Metaplasia, run by Qilu Hospital of Shandong University at 3 sites in China.
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 4 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 Zhen Li (+86-18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of AI-EGGIM ≥ 5 for Identifying Patients at High Risk of Gastric Cancer (time frame: From the endoscopy examination to completion of histopathological assessment, up to 14 days). 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 4 Nov 2026.