UnknownNot Applicable

Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.

China250 participantsStarted 2022-05-20

Plain-language summary

Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 40-80 years undergoing the confocal laser endomicroscopy examination Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endoscopists concluded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

Endoscopists derive the specificity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

Accuracy of CGGIM Score for Diagnosing OLGIM III/IV by Endoscopists

Timeframe: 2 years

AI yielded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

AI yielded the specificity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

AI yields accuracy of CGGIM score for diagnosis of OLGIM III/IV

Timeframe: 2 years

Trial details

NCT IDNCT05459428

SponsorShandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

Contact for this trial

Yanqing Li, MD, PhD

0531182169385 liyanqing@sdu.edu.cn

View on ClinicalTrials.gov More Intestinal Metaplasia of Gastric Mucosa trials

Plain-language summary

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Endoscopists concluded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

Endoscopists derive the specificity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

Accuracy of CGGIM Score for Diagnosing OLGIM III/IV by Endoscopists

Timeframe: 2 years

AI yielded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

AI yielded the specificity of CGGIM score in the diagnosis of OLGIM III/IV

Timeframe: 2 years

AI yields accuracy of CGGIM score for diagnosis of OLGIM III/IV

Timeframe: 2 years