An observational study in Gastric Intestinal Metaplasia, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 3 sites in China. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Qilu Hospital of Shandong University · Observational
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.
45 studies on the registry are indexed under Metaplasia; 11 are open to participants now.
This study's planned enrollment of 540 is above the median of 280 across 19 observational studies indexed under Metaplasia.
Browse Metaplasia studies →Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients undergoing upper gastrointestinal endoscopy who are screened to fulfill the eligibility criteria will be enrolled in the study.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: From the endoscopy examination to completion of histopathological assessment, up to 14 days
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.
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
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).
Time frame: From the endoscopy examination to completion of histopathological assessment, up to 14 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University →