Intestinal Metaplasia of Gastric MucosaNCT07257796
Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score
An observational study of Intestinal Metaplasia of Gastric Mucosa and Artificial Intelligence, run by Qilu Hospital of Shandong University at 3 sites in China.
Trial summary
The endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Intestinal Metaplasia of Gastric Mucosa, Artificial Intelligence, Endoscopy
- What is being tested?
- The diagnostic performance of AI system and endoscopists
- How many people
- 3,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2025to 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 40 to 75 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria will be enrolled into the study.
Who may be able to join
- patients aged 40-75 years who undergo the IEE examination
- 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 participate in gastroscopy
- patients with previous surgical procedures on the stomach
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, 3 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Zhen Li, 18560086106, qilulizhen@sdu.edu.cn
- Not yet recruiting
Shandong First Medical University First Affiliated Hospital
Jinan, Shandong
- Not yet recruiting
Shandong Second Provincial General Hospital
Jinan, Shandong
About this study
The endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy examination. This study is a prospective, multi-center study aimed at exploring the performance and reliability of AI-EGGIM scoring.
This is a prospective study designed to validate the AI-EGGIM system in a larger cohort. The study protocol was developed based on preliminary experience from a prior investigation (NCT05464108).
Read the detailed description
Gastric intestinal metaplasia (GIM) is an important precancerous stage in the gastric carcinogenesis cascade. The endoscopic grading system (EGGIM) has been proposed as a practical method to evaluate the extent of GIM during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically assess the extent of GIM and calculate EGGIM scores from endoscopic examinations. This study is a prospective, multi-center study aimed at evaluating the accuracy, performance, and reliability of AI-assisted EGGIM scoring.
- Being tested
- The diagnostic performance of AI system and endoscopists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The diagnostic performance of AI system and endoscopistsDiagnostic test
Eligible patients will undergo independent EGGIM score assessment by both endoscopists and the AI system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score
The performance of the AI system will be evaluated in diagnosing the grade of gastric intestinal metaplasia (IM) based on the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. EGGIM is a validated scoring method ranging from 0 to 10, reflecting the extent of IM across five gastric regions: two in the antrum, two in the corpus, and one at the incisura. Each region is scored as 0 (no IM), 1 (focal IM, ≤30% of the area), or 2 (extensive IM, >30% of the area), with a total possible score of 10. Higher EGGIM scores correspond to more severe IM and greater gastric cancer risk. The AI-derived scores will be compared with expert' EGGIM scores, which serve as the gold standard, to assess diagnostic accuracy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Nov 2025
- Primary completion31 May 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 Intestinal Metaplasia of Gastric MucosaStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257796
- Sponsor's protocol ID
- 2025SDU-QILU-5
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score
- ClinicalTrials.gov ID
- NCT07257796
- Acronym / sponsor ID
- 2025SDU-QILU-5
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (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 endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy examination. This study is a prospective, multi-center study aimed at exploring the performance and reliability of AI-EGGIM scoring.
This is a prospective study designed to validate the AI-EGGIM system in a larger cohort. The study protocol was developed based on preliminary experience from a prior investigation (NCT05464108).
Detailed description
Gastric intestinal metaplasia (GIM) is an important precancerous stage in the gastric carcinogenesis cascade. The endoscopic grading system (EGGIM) has been proposed as a practical method to evaluate the extent of GIM during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically assess the extent of GIM and calculate EGGIM scores from endoscopic examinations. This study is a prospective, multi-center study aimed at evaluating the accuracy, performance, and reliability of AI-assisted EGGIM scoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria will be enrolled into the study.
Key inclusion criteria (2 listed)
- patients aged 40-75 years who undergo the IEE examination
- patients who voluntarily sign the informed consent form
Key exclusion criteria (2 listed)
- patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
- patients with previous surgical procedures on the stomach
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 |
|---|---|---|
| The diagnostic performance of AI system and endoscopistsEligible patients will undergo independent EGGIM score assessment by both endoscopists and the AI system. | Diagnostic test | – |
Primary outcome
Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score
Time frame: 1 year
The performance of the AI system will be evaluated in diagnosing the grade of gastric intestinal metaplasia (IM) based on the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. EGGIM is a validated scoring method ranging from 0 to 10, reflecting the extent of IM across five gastric regions: two in the antrum, two in the corpus, and one at the incisura. Each region is scored as 0 (no IM), 1 (focal IM, ≤30% of the area), or 2 (extensive IM, >30% of the area), with a total possible score of 10. Higher EGGIM scores correspond to more severe IM and greater gastric cancer risk. The AI-derived scores will be compared with expert' EGGIM scores, which serve as the gold standard, to assess diagnostic accuracy.
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 2 Dec 2025.
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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 Intestinal Metaplasia of Gastric Mucosa and Artificial Intelligence, 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 2 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 2 Dec 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score (time frame: 1 year). 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 2 Dec 2025.