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

Официальное название

Gastric Cancer Prevention Strategies Based on Eradication of Helicobacter Pylori Subtypes at High Risk for Gastric Cancer: a Practical Cluster-randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Five-year gastric cancer incidence in both groups [Срок оценки: Through study completion, an average of 5 to 10 years]

Вторичные конечные точки (3)

• Ten-year gastric cancer incidence in both groups [Срок оценки: 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 [Срок оценки: Through study completion, an average of 5 to 10 years.]
• Difference in the detection of gastric precancerous lesions between the two groups [Срок оценки: Through study completion, an average of 5 to 10 years.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• People's Hospital of Tongling City — Tongling

Идентификаторы

NCT: NCT06943794 · 2025RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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