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A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers
Sponsor: Xijing Hospital
Summary
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.
Official title: A Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers
Key Details
Gender
All
Age Range
45 Years - 74 Years
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2026-08-10
Completion Date
2035-12-31
Last Updated
2026-08-18
Healthy Volunteers
Yes
Conditions
Locations (7)
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong, China
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 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