Pan-digestive tract cancer screening using blood methylation and fecal biomarkers
Official title: A Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers
Run by Xijing Hospital · NCT07769892 · Data updated 2026-11-12
This study tests a combined blood and stool biomarker approach to screen for cancers throughout the digestive tract in adults awaiting endoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years to 74 Years |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 7 sites (Zhaoqing, Guangdong and 6 other locations) |
| Status | Recruiting |
| Started | August 10, 2026 |
| Main results expected | December 31, 2035 |
| Study ends | December 31, 2035 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07769892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 45-74 who are scheduled for digestive tract endoscopic screening and are willing to participate in five-year follow-up.
✕Probably not a fit
Patients with prior cancer, those not undergoing endoscopy, or those with conditions that preclude follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study enrolls adults aged 45-74 who are scheduled for digestive tract endoscopy. Blood multi-gene methylation and fecal biomarkers (FIT and calprotectin) are collected before endoscopy, and participants are followed for five years after baseline screening. The primary goal is to determine the sensitivity and specificity of the combined biomarkers for detecting pan-digestive tract cancers. Endoscopic results will be used as reference for evaluating biomarker performance. No interventions are being tested; the study observes real-world screening outcomes over time.
Why it matters
Potential benefit: If successful, the biomarker panel could improve early detection of digestive tract cancers and inform screening strategies.
How similar studies have gone: Previous work in biomarker-based screening has shown promise, but comprehensive pan-digestive tract testing remains exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.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. Exclusion Criteria: * 1\. 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.
Where it's running
-
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong, China Recruiting -
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China Recruiting -
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan, China Recruiting -
Yanting County Tumor Hospital
Mianyang, China Recruiting -
Wuwei Cancer Hospital of Gansu Province
Wuwei, China Recruiting -
Wuxi People's Hospital
Wuxi, China Recruiting
Show 1 more location
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Zhaoqing First People's Hospital, Guangdong Province
Zhaoqing, China Recruiting
Study contacts
- Principal investigator: Yongzhan Nie — Xijing Hospital
- Study coordinator: Rong Zheng
- Email: zhengrong4956@163.com
- Phone: +86 198 2975 8242
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.