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临床试验/NCT05459610
NCT05459610Unknown不适用

Development and Validation of an Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia

Shandong University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged 18-80 years who undergo the IEE examination

排除标准

  • 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

结局指标

主要结局

The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture

时间窗: 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

时间窗: 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

时间窗: 2 years

The sensitivity of AI model to assess the degree of intestinal metaplasia in an

次要结局

  • Accuracy of the experienced endoscopists to assess the degree of intestinal metaplasia(2 years)
  • Accuracy of the inexperienced endoscopists to assess the degree of intestinal metaplasia(2 years)
  • Inter-observer agreement among experienced endoscopists in identifying the degree of intestinal metaplasia(2 years)
  • Inter-observer agreement among inexperienced endoscopists in identifying degree of intestinal metaplasia(2 years)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

Vice President of Qilu Hospital

Shandong University

研究点 (1)

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