Intestinal Metaplasia of Gastric MucosaNCT05459610
Automatic Evaluation of the Extent of Intestinal Metaplasia With Artificial Intelligence
An observational study of Intestinal Metaplasia of Gastric Mucosa and Artificial Intelligence, run by Shandong University at 1 site in China.
Trial summary
Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Metaplasia of Gastric Mucosa, Artificial Intelligence, Endoscopy
- How many people
- 600 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who receive the IEE 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 18-80 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 who refuse to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrology, QiLu Hospital, Shandong University
Jinan, Shandong, 250012
yanqing Li, MD, PHD, 0531182169385, liyanqing@sdu.edu.cn
About this study
Official title: Development and Validation of an Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia
Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, the high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.
Read the detailed description
Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Gastric intestinal metaplasia (GIM) is an intermediate precancerous gastric lesion in the gastric cancer cascade. Studies have shown that the 5-year cumulative incidence of gastric cancer in IM patients ranges from 5.3% to 9.8% . With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, The high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group for training the algorithm | This group of images is used for training the algorithm of the artificial intelligence | |
| group for testing the algorithm | This group of images is used for testing the algorithm of the artificial intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
Measured: 2 years
The accuracy of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
The accuracy of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
Measured: 2 years
The sensitivity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
The sensitivity of AI model to assess the degree of intestinal metaplasia in an
Measured: 2 years
Secondary outcomes (4)
Accuracy of the experienced endoscopists to assess the degree of intestinal metaplasia
Accuracy of the experienced endoscopists to assess the degree of intestinal metaplasia in an endoscopic picture
Measured: 2 years
Accuracy of the inexperienced endoscopists to assess the degree of intestinal metaplasia
Accuracy of the inexperienced endoscopists to assess the degree of intestinal metaplasia in an endoscopic picture
Measured: 2 years
Inter-observer agreement among experienced endoscopists in identifying the degree of intestinal metaplasia
Inter-observer agreement among experienced endoscopists in identifying the degree of intestinal metaplasia in an endoscopic picture
Measured: 2 years
Inter-observer agreement among inexperienced endoscopists in identifying degree of intestinal metaplasia
Inter-observer agreement among inexperienced endoscopists in identifying degree of intestinal metaplasia in an endoscopic picture
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 posted15 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (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.
- 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
- Retrospective
- Enrolment
- 600 participants (estimated)
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
- NCT05459610
- Sponsor's protocol ID
- 2022SDU-QILU-109
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT05459610
- Acronym / sponsor ID
- 2022SDU-QILU-109
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 15 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.
Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, the high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.
Detailed description
Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Gastric intestinal metaplasia (GIM) is an intermediate precancerous gastric lesion in the gastric cancer cascade. Studies have shown that the 5-year cumulative incidence of gastric cancer in IM patients ranges from 5.3% to 9.8% . With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, The high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group for training the algorithm | – | –This group of images is used for training the algorithm of the artificial intelligence |
| group for testing the algorithm | – | –This group of images is used for testing the algorithm of the artificial intelligence |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who receive the IEE 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 18-80 years who undergo the IEE examination
Key exclusion criteria (3 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 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.
Primary outcome
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
Time frame: 2 years
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
The accuracy of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
Time frame: 2 years
The accuracy of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
The sensitivity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
Time frame: 2 years
The sensitivity of AI model to assess the degree of intestinal metaplasia in an
4 secondary outcomes
Accuracy of the experienced endoscopists to assess the degree of intestinal metaplasia
Time frame: 2 years
Accuracy of the inexperienced endoscopists to assess the degree of intestinal metaplasia
Time frame: 2 years
Inter-observer agreement among experienced endoscopists in identifying the degree of intestinal metaplasia
Time frame: 2 years
Inter-observer agreement among inexperienced endoscopists in identifying degree of intestinal metaplasia
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- 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 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yanqing Li, MD, PHD (0531182169385, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture (time frame: 2 years). The study lists 3 primary outcomes in all. 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 15 Jul 2022.