Gastric Cancer Clinical Trial
Official title:
A Single-center, Retrospective, Open Label, Randomized Controlled Trial of Artificial Intelligence Versus Expert Endoscopists for Diagnosis of Gastric Cancer in Patients Who Underwent Upper Gastrointestinal Endoscopy
Title: A single-center, retrospective randomized controlled trial of artificial intelligence
(AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent
upper gastrointestinal endoscopy.
Précis: this single-center, retrospective randomized controlled trial will include 500
outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and
will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists.
Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of
AI and expert endoscopists.
Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms
of the number of images analyzed for diagnosis of gastric cancer and intersection over union
(IOU), and the detection rate of diagnosis of early and advanced gastric cancer.
Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based
diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20
years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a
single hospital in Japan.
Describe the Intervention: AI-based diagnosis of gastric cancer based on upper
gastrointestinal endoscopy images.
Study Duration: 3 months.
Prior to Study: Total 500: Screen potential subjects by inclusion and exclusion criteria;
obtain endoscopy images.
Randomization was performed.
Intervention: AI diagnosis was performed for 250 patients using upper gastrointestinal
endoscopy images, and Expert endoscopists diagnosis was performed for 250 patients by same
methods.
Primary analysis: Perform primary analysis of primary and secondary endpoints for 250
patients in each group
Cross over diagnosis between AI and expert endoscopists was performed.
Perform secondary analysis of agreement of gastric cancer diagnosis per images and IOU
between AI and expert endoscopists for 500 patients.
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