跳至主要内容
临床试验/NCT04840056
NCT04840056招募中不适用

Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis - Application of Artificial Intelligence in Histology and Clinical Data

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,300
试验地点
1
主要终点
Gastric cancer and gastric dysplasia

研究概览

简要总结

The primary objectives of this study are:

  • To identify clinical or histological factors associated with gastric cancer development in patients with IM and AG
  • To establish a machine learning algorithm for prediction of future gastric cancer risks and individual risk stratification in patient with IM and AG

详细描述

This is a two-part retrospective study including a clinical data part and a pathology part. A training cohort will be developed from approximately 70% of included cases. It will be followed by a validation cohort with the remaining cases.

Clinical data will be collected retrospectively using the Clinical Data Analysis and Reporting System (CDARS) and Clinical management System (CMS). A cluster-wide cohort (New Territories East Cluster, NTEC) consisting of patients with history of histologically-proven gastric IM and AG will be identified and included for subsequent analysis. The data collection period for the retrospective data will be 2000-2020.

Histology slides will be retrieved retrospectively when available (within NTEC). Whole slide imaging technique will be utilized for the development of training and validation cohorts with machine learning algorithms in the pathology part.

研究设计

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

入排标准

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

入选标准

  • Adults >= 18 years of age
  • Histologically proven atrophic gastritis or intestinal metaplasia (at antrum and/or body and/or angular of stomach)

排除标准

  • 未提供

结局指标

主要结局

Gastric cancer and gastric dysplasia

时间窗: 20 years

The primary endpoint is the incidence of gastric cancer (intestinal-type) and gastric dysplasia (low grade and high grade dysplasia).

次要结局

  • Negative predictive value of machine learning model(20 years)
  • Overall accuracy of machine learning model(20 years)
  • Sensitivity of machine learning model(20 years)
  • Specificity of machine learning model(20 years)
  • Positive predictive value of machine learning model(20 years)
  • Area under the receiver operating characteristic curve of machine learning model(20 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louis Ho Shing Lau

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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