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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
10,000
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.
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong, China
RECRUITINGThe 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan, China
RECRUITINGYanting County Tumor Hospital
Mianyang, China
RECRUITINGWuwei Cancer Hospital of Gansu Province
Wuwei, China
RECRUITINGWuxi People's Hospital
Wuxi, China
RECRUITINGZhaoqing First People's Hospital, Guangdong Province
Zhaoqing, China
RECRUITINGDifferences 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.
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
Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group
Time frame: Baseline
All-cause mortality in the two groups
Time frame: 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
Incidence of endoscopy-related complications
Time frame: Incidence of various endoscopy-related complications observed within 5 years
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