Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: recommendations for Hp eradication treatment.
- Who it may be relevant to
- Registry conditions: Gastric (Stomach) Cancer. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gastric Cancer Prevention Strategies Based on Eradication of Helicobacter Pylori Subtypes at High Risk for Gastric Cancer: a Practical Cluster-randomized Controlled Trial
Overview
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.
Detailed description
Primary study objective: To compare the five-year gastric cancer incidence between the two groups during the follow-up period and assess the impact of the eradication strategy on the prevention of gastric cancer.
Secondary study objective: 1. To compare the ten-year gastric cancer incidence between the two groups during the follow-up period and further evaluate the long-term impact of the eradication strategy on the prevention of gastric cancer. 2. To compare the "high-risk SNP subtype eradication strategy" with routine Hp management in detecting early gastric cancer: Evaluate the difference in early gastric cancer detection between the intervention group and the routine management group during follow-up. 3. To compare the "high-risk SNP subtype eradication strategy" with routine Hp management in detecting gastric precancerous lesions: Assess the difference in the detection of gastric precancerous lesions between the two groups.
Other study objective: To evaluate the impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence.
Randomization: Subjects with high-risk subtypes who met the inclusion criteria were grouped into clusters and then randomized into an intervention group and a control group.
Intervention:
* Intervention group: Received standardized H. pylori eradication treatment recommendations provided by trial staff/physicians based on patient risk, clinical symptoms, and other factors. * Control group: Received standardized follow-up and routine management without treatment guidance for high-risk Hp subtypes.
Follow-up and Comparison:
The follow-up will compare the differences between the two groups in terms of the detection rate of gastric cancer or precancerous lesions, the incidence (or progression) of gastric cancer, patient adherence, and complications within a specified follow-up period.
Interventions
- Drug recommendations for Hp eradication treatment
A 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
Primary outcome measures
- Five-year gastric cancer incidence in both groups [Time frame: Through study completion, an average of 5 to 10 years]
Secondary outcome measures (3)
- Ten-year gastric cancer incidence in both groups [Time frame: Through study completion, an average of 5 to 10 years.]
- Difference in early gastric cancer detection between the intervention group and the routine management group during follow-up [Time frame: Through study completion, an average of 5 to 10 years.]
- Difference in the detection of gastric precancerous lesions between the two groups [Time frame: Through study completion, an average of 5 to 10 years.]
Eligibility criteria
Inclusion criteria
- 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.
- Detected as high-risk by Hp subtype test.
Exclusion criteria
- 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.
- Other conditions that the investigator deems inappropriate for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- People's Hospital of Tongling City — Tongling
Identifiers
NCT: NCT06943794 · 2025RCT