Stool-based multi-target DNA screening for stomach cancer
A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire
This project tests whether a stool multi-target DNA test (detecting Helicobacter pylori genes and methylated DNA markers) can help find stomach cancer earlier in people aged 40 and over.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Tongling) |
| Trial ID | NCT06943807 on ClinicalTrials.gov |
What this trial studies
This prospective program will recruit about 10,000–15,000 residents from selected communities in Tongling City who are 40 years or older to provide a stool sample and complete a gastric cancer risk questionnaire. Screening positives—defined by a positive stool multi-target DNA test or a high-risk questionnaire—will be referred for diagnostic fiberoptic endoscopy and biopsy. Individuals not diagnosed with cancer in the first year will enter annual follow-up, and leftover stool specimens will be stored at the Fudan University Shanghai Cancer Center biobank for future biomarker research. The study compares H. pylori gene detection and fecal methylated DNA markers, alone and in combination, to see if they enable earlier gastric cancer diagnosis.
Who should consider this trial
Good fit: Ideal candidates are local residents aged 40 or older who can give informed consent, have no prior digestive tract cancer, and can undergo endoscopy if screening is positive.
Not a fit: People with a history of gastric or other digestive tract cancers, severe comorbidities that limit follow-up, pregnancy or breastfeeding, or inability to undergo endoscopy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier, less invasive detection of stomach cancer through a simple stool test, allowing earlier treatment.
How similar studies have performed: Multi-target fecal DNA testing has proven useful for colorectal cancer screening, but using fecal methylation markers combined with H. pylori DNA specifically for gastric cancer is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥40 years, male or female. 2. No contraindications to endoscopy and able to cooperate with endoscopy. 3. Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person. Exclusion Criteria: 1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract. 2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical. 3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior. 4. Pregnant or breastfeeding women. 5. Other conditions that the investigator deems inappropriate for participation in the study.
Where this trial is running
Tongling
- People's Hospital of Tongling City — Tongling, China (Recruiting)
Study contacts
- Study coordinator: Dazhi Xu, PhD
- Email: xudzh@fudan.edu.cn
- Phone: 86-18121299796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.