Gastric Cancer Prevention Strategies Based on Eradication of Helicobacter Pylori Subtypes at High Risk for Gastric Cancer: a Practical Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,824
- 试验地点
- 1
- 主要终点
- Five-year gastric cancer incidence in both groups
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant)
盲法说明
Subjects (high-risk SNP-positive) are uninformed about their group assignment (conventional treatment, intervention guidance) during the study. The high-risk Hp subtype steering group was informed about their subgroup. Collection of assessment data and data analysis statisticians were blinded.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group (high-risk Hp subtype guidance + eradication treatment)
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.
干预措施: recommendations for Hp eradication treatment (Drug)
Control group (routine Hp management)
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.
结局指标
主要结局
Five-year gastric cancer incidence in both groups
时间窗: Through study completion, an average of 5 to 10 years
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.
次要结局
- Ten-year gastric cancer incidence in both groups(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(Through study completion, an average of 5 to 10 years.)
- Difference in the detection of gastric precancerous lesions between the two groups(Through study completion, an average of 5 to 10 years.)
研究者
Dazhi Xu
Director of the gastric surgery department
Fudan University