jRCT1060220108已完成不适用
Performance test of a diagnostic support program for evaluating the depth of invasion of early gastric cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Individuals who are 20 years of age or older at the time of endoscopic image acquisition.
- •Individuals who can provide early gastric cancer tissue suitable for pathological diagnosis by a pathological evaluator.
- •Individuals who can provide images that meet the following criteria for endoscopic images:
- •Images captured using White Light mode
- •Vertical resolution of 700 pixels or more and horizontal resolution of 800 pixels or more (image area)
- •Images captured using an Olympus or Fujifilm endoscope
- •Five or more images per lesion
- •Suitable for deep depth diagnosis, as shown below
- •The entire gastric tumor is generally visible (without using close-up or magnifying endoscopy, etc.)
- •The details of the tumor's shape can be observed (without moving the lens too far from the tumor)
- •Sufficient insufflation is performed.
排除标准
- •The following images are excluded
- •Images that do not show the gastric tumor (such as normal areas)
- •Images taken after treatment such as biopsy or clipping, or images with severe bleeding
- •Images that show foreign objects such as food residue
- •Blurred or unclear images due to poor focus or other factors
- •Images that only show a portion of the lesion due to magnifying endoscopy or close-up photography
- •Individuals who have undergone gastric resection or gastric tube reconstruction at the time of endoscopic image acquisition or specimen collection.
- •Individuals with lesions extending to the esophagus or duodenum at the time of endoscopic image acquisition or specimen collection.
- •Individuals with a history of chemotherapy or radiation therapy to the upper abdomen within the year prior to the target endoscopic examination.
- •Patients who have refused to participate in the study.
结局指标
主要结局
-
Sensitivity of mucosal gastric cancer (M cancer) diagnosed by this program.
次要结局
- Diagnostic accuracy rate of mucosal gastric cancer (M cancer) diagnosed by this program
- Specificity of mucosal gastric cancer (M cancer) diagnosed by this program
研究者
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