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Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
Sponsor: Xijing Hospital
Summary
This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.
Official title: Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2026-08-10
Completion Date
2027-12-31
Last Updated
2026-08-11
Healthy Volunteers
Yes
Conditions
Interventions
Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkers
Stool samples are collected from participants before endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing. The results are used to screen for gastrointestinal cancers.
Locations (13)
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
Hami, China
Cao County People's Hospital
Heze, China
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan, China
PetroChina Central Hospital, Hebei
Langfang, China
Huoqiu County People's Hospital
Liu‘an, China
Qingdao Municipal Hospital
Qingdao, China
Central Theater Command General Hospital
Wuhan, China
Wuwei Cancer Hospital of Gansu Province
Wuwei, China
Wuxi People's Hospital
Wuxi, China
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, China
Zhaoqing First People's Hospital, Guangdong Province
Zhaoqing, China