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

August 17, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 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
Time Frame: Day 1 At endoscopy and pathological confirmation after enrollment
Day 1 At endoscopy and pathological confirmation after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
Time Frame: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
Time Frame: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
Time Frame: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 5 years after enrollment
5 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Yongzhan Nie, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2026

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262029-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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