跳至主要内容
临床试验/NCT05638243
NCT05638243招募中不适用

Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program in Xuhui District, Shanghai

Fudan University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2022年8月20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
10,000
试验地点
1
主要终点
Proportion of subjects receiving colonoscopy

研究概览

简要总结

The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%.

This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 years old and<75 years old;
  • The initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive); ③ Receive sample collection; ④ Sign the informed consent form.

排除标准

  • ① History of colorectal cancer, colorectal adenoma, and treatment;
  • Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.

结局指标

主要结局

Proportion of subjects receiving colonoscopy

时间窗: Three years

Proportion of subjects receiving colonoscopy

Proportion of subjects suffering early colorectal cancer

时间窗: Three years

Proportion of stageⅠcancer in total colorectal cancer

Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

时间窗: Three years

Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

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

Xu jianmin

Director of Colorectal Surgery

Fudan University

研究点 (1)

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