跳至主要内容
临床试验/NCT07312500
NCT07312500进行中(未招募)不适用

Application of Fecal DNA Methylation and Fecal Helicobacter Pylori Gastric Cancer Susceptibility Genes in Clinical Diagnosis, Treatment, and Relapse and Metastasis of Gastric Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,000
试验地点
1
主要终点
Positive predictive value of early diagnosis of gastric cancer

研究概览

简要总结

Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. In addition, the study observed the association between different loci and post-treatment recurrence, metastasis, or long-term survival rate through long-term follow-up of gastric cancer patients; Follow up with individuals with benign diseases such as gastritis and healthy individuals, compare cases of gastric cancer, and compare their sample data during follow-up with controls who did not have the disease.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Age ≥ 18 years old, male or female not limited.
  • Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.
  • Patients must be able to fully understand the informed consent form and be able to personally sign it.

排除标准

  • Severe heart, liver, kidney dysfunction, or mental illness.
  • History of malignant tumors in the upper gastrointestinal tract.
  • Pregnant women.
  • Those with unclear pathology.
  • Those with unsatisfactory sample retention (such as insufficient sample size).

结局指标

主要结局

Positive predictive value of early diagnosis of gastric cancer

时间窗: baseline

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

Dazhi Xu

Director of the gastric surgery department

Fudan University

研究点 (1)

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