Gastrointestinal cancer screening using a multi-target detection model
Official title: A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model: A Multi-center Prospective Randomized Controlled Trial
Run by Xijing Hospital · NCT07712107 · Data updated 2026-11-12
A randomized trial tests whether a combined blood and stool screening approach can reduce 5-year gastrointestinal cancer deaths compared with standard routine observation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 74 Years |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 6 sites (Zhaoqing, Guangdong and 5 other locations) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | December 31, 2035 |
| Study ends | December 31, 2035 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07712107 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 45–74 without a history of cancer and who are willing to be randomized and commit to five years of follow-up.
✕Probably not a fit
Patients who do not benefit may be those unlikely to benefit from early screening due to short life expectancy or those at high risk where screening would be unsafe or not beneficial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial compares two screening strategies for adults aged 45–74. Participants are randomly assigned to receive a combined screening model (blood methylation plus fecal tests) with follow-up endoscopy for positives or routine observation for negatives, or routine observation alone. All participants are followed for five years to track gastrointestinal cancer incidence and mortality. The study aims to determine if the active screening strategy lowers cancer mortality compared with routine care.
Why it matters
Potential benefit: If successful, the approach could enable earlier detection and potentially reduce deaths from gastrointestinal cancers.
How similar studies have gone: Previous studies using multi-target screening concepts have shown promise, but this exact combination plus long-term mortality outcomes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be between 45 and 74 years of age at the time of enrollment; * Participants must agree to be randomly assigned to different screening and follow-up strategies; * Participants must agree to undergo a five-year follow-up in accordance with the protocol; * Participants must be willing to participate and sign an informed consent form. Exclusion Criteria: * Underwent upper gastrointestinal endoscopy screening within the past year; * History of any type of malignant tumor; * Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders; * Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy); * Pregnant or breastfeeding women.
Where it's running
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Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong, 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 -
Zhaoqing First People's Hospital, Guangdong Province
Zhaoqing, China Recruiting
Study contacts
- Study coordinator: Yongzhan Nie
- 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.