A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model

ClinicalTrials.gov ID

NCT07712107

Lead Sponsor

Xijing HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

10,000Estimated

Last Update Posted

Aug 14, 2026Actual

Start Date

Jun 15, 2026Actual

Primary Completion Date

Dec 31, 2035Estimated

Completion Date

Dec 31, 2035Estimated

Official Title

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

Brief Summary

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.

• Gastrointestinal Tumors

• Multi-target blood methylation + fecal FIT + fecal calprotectin

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Underwent upper gastrointestinal endoscopy screening within the past year;
• History of any type of malignant tumor;
• 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;
• 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);
• Pregnant or breastfeeding women.

Primary Purpose

Screening

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Xijing HospitalOTHER

546331446@qq.com+86 13778157819

lulinzh12006@163.com+8613659359016

fangmeian@njmu.edu.cn+8613382241680

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