A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model: A Multi-center Prospective Randomized Controlled Trial

July 13, 2026 updated by: Xijing Hospital
This study is a multicenter, randomized controlled trial. The plan is to enroll eligible participants and randomly assign them to two groups: one group will undergo testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calpetin"; those with positive results will immediately undergo standard gastrointestinal endoscopy, while those with negative results will enter routine observation; the other group will undergo only routine observation and follow-up. All enrolled participants will undergo a 5-year prospective follow-up, during which information on gastrointestinal cancer incidence and mortality will be collected through regular contact and review of medical records. The primary endpoint of the study is the difference in 5-year all-gastrointestinal cancer mortality between the two groups.This project aims to use a randomized controlled trial design to evaluate whether an active screening strategy based on a combined model can effectively reduce the population-level mortality from gastrointestinal cancers compared to routine surveillance. The objective is to provide high-level evidence for establishing a new screening strategy that reduces the disease burden and delivers public health benefits. It lays the foundation for validating novel biomarkers and exploring the biological and behavioral factors that influence screening outcomes, and offers clear decision-making support for optimizing China's comprehensive prevention and control system for gastrointestinal cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

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:

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

Description

Inclusion Criteria:

  • 1) Participants must be between 45 and 74 years of age at the time of enrollment; 2) Participants must agree to be randomly assigned to different screening and follow-up strategies; 3) Participants must agree to undergo a five-year follow-up in accordance with the protocol; 4) Participants must be willing to participate and sign an informed consent form.

Exclusion Criteria:

  • 1) Underwent upper gastrointestinal endoscopy screening within the past year; 2) History of any type of malignant tumor; 3) Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders; 4) Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy); 5) Pregnant or breastfeeding 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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: Intervention group
Diagnostic test: Multi-target blood methylation + fecal FIT + fecal calprotectin
The intervention group underwent testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calprotectin"; those with positive results subsequently underwent standard gastrointestinal endoscopy, while those with negative results were placed under routine observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups.
Time Frame: Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.
Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of gastrointestinal cancer in the two groups
Time Frame: Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment
Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment
Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group
Time Frame: Diagnostic performance metrics calculated based on baseline screening results and the gold standard of pathology
Diagnostic performance metrics calculated based on baseline screening results and the gold standard of pathology
All-cause mortality in the two groups
Time Frame: All-cause mortality among all participants within 5 years of enrollment
All-cause mortality among all participants within 5 years of enrollment
Detection rate of precancerous lesions and early-stage gastrointestinal tumors
Time Frame: At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
Incidence of endoscopy-related complications
Time Frame: Incidence of various endoscopy-related complications observed within 5 years
Incidence of various endoscopy-related complications observed within 5 years

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Collaborators

Wuxi People's Hospital
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing First People's Hospital, Guangdong Province
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Wuwei Cancer Hospital of Gansu Province
Yanting County Tumor 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 (Actual)

June 15, 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

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262032-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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