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RECRUITING
NCT07600125

Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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