A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model
1 other identifier
interventional
10,000
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2026
CompletedFirst Submitted
Initial submission to the registry
July 13, 2026
CompletedFirst Posted
Study publicly available on registry
July 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
July 30, 2026
January 1, 2026
9.6 years
July 13, 2026
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups.
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 Outcomes (5)
The incidence of gastrointestinal cancer in the two groups
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
Baseline
All-cause mortality in the two groups
All-cause mortality among all participants within 5 years of enrollment
Detection rate of precancerous lesions and early-stage gastrointestinal tumors
At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
Incidence of endoscopy-related complications
Incidence of various endoscopy-related complications observed within 5 years
Study Arms (2)
Intervention group
EXPERIMENTALcontrol group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhaoqing Gaoyao People's Hospitalcollaborator
- First People's Hospital of Zhaoqingcollaborator
- The 960th Hospital of PLAcollaborator
- Gansu Wuwei Tumor Hospitalcollaborator
- Xijing Hospitallead
- Wuxi People's Hospitalcollaborator
- Yanting County Tumor Hospitalcollaborator
Study Sites (6)
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong, China
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan, China
Yanting County Tumor Hospital
Mianyang, China
Wuwei Cancer Hospital of Gansu Province
Wuwei, China
Wuxi People's Hospital
Wuxi, China
Zhaoqing First People's Hospital, Guangdong Province
Zhaoqing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2026
First Posted
July 17, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
December 31, 2035
Study Completion (Estimated)
December 31, 2035
Last Updated
July 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
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.