Intestinal Metaplasia of Gastric MucosaNCT05464108
Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia
An observational study of Intestinal Metaplasia of Gastric Mucosa and Artificial Intelligence, run by Shandong University at 1 site in China.
Trial summary
The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. 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 diagnosis of Artificial Intelligence and endosopists
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Who may be able to join
- patients aged 40-75 years who undergo the IEE examination
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
- patients with contraindications to biopsy
- patients who refuse to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastrology, QiLu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of
The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. The investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.
Read the detailed description
Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. An EGGIM score of 5 was the best cut off value for identifying OLGIM stage III/IV patients. The investigators have designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.
- Being tested
- The diagnosis of Artificial Intelligence and endosopists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The diagnosis of Artificial Intelligence and endosopistsDiagnostic test
Endosopists and AI will assess the EGGIM score independently when the patients is eligible. In addition, they can not see the OLGIM score of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Gastric intestinal metaplasia observed by IEE | Get pictures from gastric antrum body and angle by image-enhanced endoscopy in order to calculate the EGGIM score. Receives: Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score
A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.
Measured: 2 years
Secondary outcomes (4)
Accuracy of experienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score
A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.
Measured: 2 years
Accuracy of inexperienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score
A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.
Measured: 2 years
Inter-observer agreement among experienced endoscopists in identifying the EGGIM scores
A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.
Measured: 2 years
Inter-observer agreement among inexperienced endoscopists in identifying the EGGIM scores
A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- yanqing Li, MD, PHD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464108
- Sponsor's protocol ID
- 2022SDU-QILU-111
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of
- ClinicalTrials.gov ID
- NCT05464108
- Acronym / sponsor ID
- 2022SDU-QILU-111
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 19 Jul 2022 (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 operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. The investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.
Detailed description
Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. An EGGIM score of 5 was the best cut off value for identifying OLGIM stage III/IV patients. The investigators have designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric intestinal metaplasia observed by IEE | – | Diagnostic Test: The diagnosis of Artificial Intelligence and endosopistsGet pictures from gastric antrum body and angle by image-enhanced endoscopy in order to calculate the EGGIM score. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Key inclusion criteria (1 listed)
- patients aged 40-75 years who undergo the IEE examination
Key exclusion criteria (5 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
- patients with contraindications to biopsy
- patients who refuse to sign the informed consent form
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 diagnosis of Artificial Intelligence and endosopistsEndosopists and AI will assess the EGGIM score independently when the patients is eligible. In addition, they can not see the OLGIM score of the patients. | Diagnostic test | Gastric intestinal metaplasia observed by IEE |
Primary outcome
Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score
Time frame: 2 years
A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.
4 secondary outcomes
Accuracy of experienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score
Time frame: 2 years
Accuracy of inexperienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score
Time frame: 2 years
Inter-observer agreement among experienced endoscopists in identifying the EGGIM scores
Time frame: 2 years
Inter-observer agreement among inexperienced endoscopists in identifying the EGGIM scores
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
yanqing Li, MD, PHD study chair
Qilu Hospital of Shandong University
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 Intestinal Metaplasia of Gastric Mucosa and Artificial Intelligence, run by Shandong University at 1 site 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 3 Dec 2024. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score (time frame: 2 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 3 Dec 2024.