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临床试验/NCT07462247
NCT07462247招募中不适用

Establishment of Image Database for Early Upper Gastrointestinal Cancer, Precancerous Lesions, and Precancerous Conditions

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年3月11日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, and CT images

研究概览

简要总结

The study is designed to collect magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, CT images, and histopathology results to establish a database for early upper gastrointestinal cancer, precancerous lesions, and precancerous conditions.

详细描述

Images of MCE for UGIC are scarce, limiting the development of corresponding AI diagnostic model. We aim to create an image database with MCE images, EGD images, CT images, and histopathology results, in patients treated by ESD for early upper gastrointestinal cancer, or biopsy for precancerous lesions, and precancerous conditions, so as to facilitate image-based deep learning studies.

研究设计

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

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

  • Male or female participants aged ≥ 18 years
  • Patients with early upper gastrointestinal cancer referred for endoscopic submucosal dissection (ESD), or patients with upper gastrointestinal precancerous lesions or precancerous conditions referred for biopsy by esophagogastroduodenoscopy (EGD)
  • Participants who are willing and able to participate in this study, complete all required examinations and follow-up visits, and who have provided written informed consent

排除标准

  • Patients who are not eligible for surgery or who refuse any abdominal surgery in case of capsule retention and endoscopic retrieval failure
  • Patients with cardiac pacemaker or other implanted electromedical devices which could interfere with magnetic resonance
  • Suspected or known intestinal stenosis or other known risk factors for capsule retention
  • Patients with dysphagia
  • Allergy to polymeric materials, latex, simethicone, or pronase
  • Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule
  • Patients with any condition that precludes compliance with the study

结局指标

主要结局

Magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, and CT images

时间窗: Prior to ESD or biopsy

Histopathology results

时间窗: During ESD or biopsy

次要结局

未报告次要终点

研究者

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

Jun Pan

Principal Investigator

Changhai Hospital

研究点 (1)

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