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A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers

2026年8月17日 更新者：Xijing Hospital

A Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers

This project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract endoscopy are enrolled. Blood and stool samples are collected prior to endoscopic examination for detection of blood multi-gene methylation, fecal immunochemical test (FIT) and calprotectin. Endoscopic procedures are then performed. Following completion of baseline endoscopic screening, all enrolled participants will be followed up for 5 years. The primary endpoint of this study is the sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for pan-digestive tract cancers.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

5000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Jinan、中国
        • 招聘中
        • The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
        • 接触：
      • Mianyang、中国
        • 招聘中
        • Yanting County Tumor Hospital
        • 接触：
      • Wuwei、中国
        • 招聘中
        • Wuwei Cancer Hospital of Gansu Province
        • 接触：
      • Wuxi、中国
        • 招聘中
        • Wuxi People's Hospital
        • 接触：
      • Zhaoqing、中国
        • 招聘中
        • Zhaoqing First People's Hospital, Guangdong Province
        • 接触：
    • Guangdong
      • Zhaoqing、Guangdong、中国
        • 招聘中
        • Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国、710032
        • 招聘中
        • The First Affiliated Hospital of Air Force Military Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Eligible subjects shall be aged 45 to 74 years at enrollment, scheduled to receive digestive tract endoscopic screening, willing to complete five-year follow-up as specified by the protocol, and capable of signing the informed consent form.

描述

Inclusion Criteria:

  • 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.

Exclusion Criteria:

  • 1. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard
大体时间：Day 1 At endoscopy and pathological confirmation after enrollment
Day 1 At endoscopy and pathological confirmation after enrollment
Specificity of combined biomarkers for pan-digestive tract cancer screening
大体时间：Day 1 At endoscopy and pathological confirmation after enrollment
Day 1 At endoscopy and pathological confirmation after enrollment

次要结果测量

结果测量
大体时间
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
大体时间：5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
大体时间：5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
大体时间：5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
大体时间：5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer
大体时间：5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer
大体时间：5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer
大体时间：5 years after enrollment
5 years after enrollment
Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality.
大体时间：5 years after enrollment
5 years after enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Xijing Hospital

调查人员

  • 首席研究员：Yongzhan Nie、Xijing Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月10日

初级完成 (估计的)

2035年12月31日

研究完成 (估计的)

2035年12月31日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KY20262029-C-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Applications shall be submitted to the principal investigator upon study completion. Applicants are required to provide a data analysis plan, and data sharing will be approved after assessment.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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