Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,403
- 试验地点
- 1
- 主要终点
- Detection rates of H. pylori infection
研究概览
简要总结
There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program.
Initially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
详细描述
Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies.
Objective
A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.
Methods：Open labeled, randomized controlled trial Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
Outcome analysis:
- Detection rate of H. pylori infection
- To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
- To assess the diagnostic accuracy of these tests.
- To verify the compliance(/adherence) and feasibility of this two-stage screening method
- Long-term Outcomes: To assess the risk reduction of gastric cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 20 years or older
- •Never screened and treated for H. pylori infection
排除标准
- •Ever undergone gastrectomy
- •Patients with gastric cancer
- •Have been screened or tested for H. pylori infection
- •Ever received H. pylori eradication therapy
- •Have taken proton pump inhibitor within two weeks
- •Have taken antibiotics within two weeks
结局指标
主要结局
Detection rates of H. pylori infection
时间窗: 2-8 weeks
The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.
次要结局
- The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups(2 weeks to 1 year)