Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial

Fudan University

Status: Begins enrollment this month

Conditions: Gastric (Stomach) Cancer

Treatments: Drug: recommendations for Hp eradication treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06943794

2025RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,824 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

1. Age ≥ 40 years, gender is not limited.
2. Voluntary participation with signed informed consent.
3. No H. pylori eradication treatment received within the past 1 month.
4. Able to complete stool sample collection and related examinations as per study requirements.
5. Detected as high-risk by Hp subtype test.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,824 participants in 2 patient groups

Treatment group (high-risk Hp subtype guidance + eradication treatment)

Experimental group

Description:

The guidance team, consisting of the attending physician and trial-related personnel, will conduct individualized assessments and education based on factors such as Hp infection, SNP results, gastric mucosa condition, and medical history, and provide eradication treatment recommendations.

Treatment:

Drug: recommendations for Hp eradication treatment

Control group (routine Hp management)

No Intervention group

Description:

According to the routine management of HP infected patients, symptomatic relief treatment will be provided, and no intervention guidance from the 'high-risk Hp subtype guidance group' will be given.