A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers
1 other identifier
observational
5,000
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2026
CompletedStudy Start
First participant enrolled
August 10, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
August 18, 2026
June 1, 2026
9.4 years
July 13, 2026
August 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity 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
Day 1 At endoscopy and pathological confirmation after enrollment
Specificity of combined biomarkers for pan-digestive tract cancer screening
Day 1 At endoscopy and pathological confirmation after enrollment
Secondary Outcomes (8)
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
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
5 years after enrollment
- +3 more secondary outcomes
Eligibility Criteria
Eligible subjects shall be aged 45 to 74 years at enrollment, scheduled to receive digestive tract endoscopic screening, willing to complete five-year follow-up as specified by the protocol, and capable of signing the informed consent form.
You may qualify if:
- Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.
You may not qualify if:
- \. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (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, 710032, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongzhan Nie
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2026
First Posted
August 18, 2026
Study Start
August 10, 2026
Primary Completion (Estimated)
December 31, 2035
Study Completion (Estimated)
December 31, 2035
Last Updated
August 18, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Applications shall be submitted to the principal investigator upon study completion. Applicants are required to provide a data analysis plan, and data sharing will be approved after assessment.