About this trial
This study is a prospective, multicenter cluster randomized controlled trial. Additional fecal screening for high-risk SNP subtypes, in conjunction with routine Hp testing, may improve the identification of individuals at high risk for gastric cancer. Moreover, the implementation of eradication interventions in high-risk groups has the potential to significantly reduce the incidence and progression of gastric cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 40 years, gender is not limited.
Voluntary participation with signed informed consent.
No H. pylori eradication treatment received within the past 1 month.
Able to complete stool sample collection and related examinations as per study requirements.
Disqualifiers
A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
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.
Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
Pregnant or breastfeeding women.
Trial design
Parallel
Treatments tested in this trial
recommendations for Hp eradication treatment
DrugA high-risk Hp subtype guidance group consisting of the receiving physician + trial-related personnel conducts individualized assessment based on Hp infection, SNP test results, gastric mucosa condition, medical history and other factors, and provides subjects with medical explanations and recommendations for eradication treatment. Eradication group protocol: standard quadruple therapy for H. pylori eradication program (PPI + bismuth + two antibiotics) 1. Omeprazole (or esomeprazole): 20mg, 2 times/day 2. Bismuth citrate: 220mg, 2 times/day 3. Metronidazole: 400mg, 3 times/day 4. Tetracycline: 500mg, 3 times/day 5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test.
Treatment groups
Trial outcomes
Primary outcomes
Five-year gastric cancer incidence in both groups
To compare the incidence of gastric cancer between the two groups during the follow-up period to assess the impact of the eradication strategy on the prevention of gastric cancer.
Secondary outcomes
Ten-year gastric cancer incidence in both groups
To compare the incidence of gastric cancer between the two groups during the follow-up period to further evaluate the long-term impact of the eradication strategy on the prevention of gastric cancer.
Difference in early gastric cancer detection between the intervention group and the routine management group during follow-up
To comparison of the "high-risk SNP subtype eradication strategy" and routine Hp management in detecting early gastric cancer.
Difference in the detection of gastric precancerous lesions between the two groups
To comparison of the "high-risk SNP subtype eradication strategy" and routine Hp management in detecting gastric precancerous lesions.
Other outcomes
Impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence
To evaluate how the eradication strategy affects adherence to treatment and management of Hp infection.
Sponsors and contacts
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