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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 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
RECRUITINGSensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard
Time frame: Day 1 At endoscopy and pathological confirmation after enrollment
Specificity of combined biomarkers for pan-digestive tract cancer screening
Time frame: Day 1 At endoscopy and pathological confirmation after enrollment
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer
Time frame: 5 years after enrollment
Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality.
Time frame: 5 years after enrollment
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