NCT07915843Not yet recruiting
Multi-center Prospective Validation of Real-Time AI-EGGIM System
Prospective Multi-center Validation of a Real-Time Artificial Intelligence-Assisted EGGIM System for Gastric Cancer Stratification
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 540 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- NCT number
- NCT07915843
What you commit to
- Study type: Observational
- Planned participants: 540
- From 1 Nov 2026 to the primary completion date, 31 Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having an upper gastrointestinal endoscopy who are aged 40-75 years, or who have had H. pylori infection or known stomach lesions that can lead to cancer.
- Age
- 40-75 years, or any age with a history of H. pylori infection and/or known premalignant gastric lesions (e.g., atrophic gastritis and IM)
- Sex
- All sexes can join.
- Disease stage
- People having an upper gastrointestinal endoscopy. A history of H. pylori infection and/or known premalignant gastric lesions (e.g., atrophic gastritis and IM) is one way to join.
- Earlier treatment
- People who have had previous stomach surgery cannot join.
Main reasons for not taking part
- Severe heart, brain, lung or kidney problems, or psychiatric disorders, that make upper endoscopy impossible
- Previous surgery on the stomach
- Upper gastrointestinal cancer
- A medical reason that rules out a stomach lining biopsy
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with previous surgical procedures on the stomach
Other illness
- patients with severe cardiac, cerebral, pulmonary, or renal dysfunction or psychiatric disorders who cannot receive upper gastrointestinal endoscopy
- patients with upper gastrointestinal cancer
Other
- patients with contraindication to gastric mucosal biopsy
Who the study is looking for
- 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
Sex: All
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Medical and Pharmaceutical University Hospital | Binzhou | China | Unknown status |
| Qilu Hospital of Shandong University | Jinan | China | Unknown status |
| Qilu Hospital of Shandong University (Qingdao) | Qingdao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.