A Multicenter Clinical Study of Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,176
- 试验地点
- 4
- 主要终点
- Evaluation of consistency between fecal gene detection kit and first generation sequencing
研究概览
简要总结
The purpose of this study was to evaluate the detection ability of Helicobacter pylori 23S rRNA/gyrA gene mutation detection kit (fluorescent PCR fusion curve method) for Helicobacter pylori gene mutation.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requriment will be included in this simultaneous blind test.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Helicobacter pylori infection who need gastroscopy;
- •patients with positive Helicobacter pylori culture in gastric mucosa
- •Helicobacter pylori negative patients
排除标准
- •1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy
结局指标
主要结局
Evaluation of consistency between fecal gene detection kit and first generation sequencing
时间窗: 4 weeks
Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and first generation sequencing
Evaluation of consistency between fecal gene detection kit and Drug sensitivity test
时间窗: 4 weeks
Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and drug sensitivity test
次要结局
未报告次要终点
研究者
Zhenyu Zhang
Senior professional title
Nanjing First Hospital, Nanjing Medical University