Gastric cancer screening using stool H. pylori high-risk gene testing and a risk questionnaire
Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer
We are testing whether a stool H. pylori genetic risk test plus a short risk questionnaire can find gastric cancer earlier in adults aged 40 and older.
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 | NCT06943781 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational screening effort to recruit 10,000–15,000 residents from selected communities in Tongling City. Each participant provides a stool sample for fecal H. pylori gastric cancer susceptibility (SNP) testing and completes a face-to-face gastric cancer risk questionnaire after providing informed consent. Anyone who tests positive on the stool test or is identified as high-risk by the questionnaire is referred for confirmatory fiberoptic endoscopy and biopsy, and those not diagnosed in the first year enter annual follow-up. Residual fecal samples will be banked at Fudan University Shanghai Cancer Center for future biomarker research.
Who should consider this trial
Good fit: Adults aged 40 years or older living in the selected Tongling communities who can give informed consent and can undergo endoscopy if referred.
Not a fit: People under 40, those with prior gastric or other digestive tract cancers, pregnant or breastfeeding women, or those too medically frail to undergo endoscopy are unlikely to benefit from this screening approach.
Why it matters
Potential benefit: If successful, this combined noninvasive screening approach could detect people at higher risk for gastric cancer earlier, enabling earlier diagnostic workup and treatment.
How similar studies have performed: Noninvasive H. pylori tests have proven useful for detecting infection, but using fecal H. pylori SNP panels specifically to predict gastric cancer susceptibility 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.