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临床试验/NCT05200611
NCT05200611
Unknown
不适用

Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening

Shandong University2 个研究点 分布在 1 个国家目标入组 5,000 人2022年1月4日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Colorectal Cancer
发起方
Shandong University
入组人数
5000
试验地点
2
主要终点
The efficacy of fecal immunochemical test to detect advanced adenoma
最后更新
4年前

概览

简要总结

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

详细描述

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

注册库
clinicaltrials.gov
开始日期
2022年1月4日
结束日期
2022年7月1日
最后更新
4年前
研究类型
Observational
性别
All

研究者

发起方
Shandong University
责任方
Principal Investigator
主要研究者

Yanqing Li

Clinical Professor

Shandong University

入排标准

入选标准

  • Adults 50-75 years old

排除标准

  • People with history of intestinal surgery;
  • People with history of colorectal cancer;
  • People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
  • People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea;
  • Pregnancy, lactation or menstrual phase;
  • Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

结局指标

主要结局

The efficacy of fecal immunochemical test to detect advanced adenoma

时间窗: 6 months

The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma

次要结局

  • The efficacy of fecal immunochemical test to detect colorectal cancer(6 month)
  • The efficacy of fecal immunochemical test to detect colorectal neoplasms(6 month)

研究点 (2)

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