Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Sensitivity of GastroPanel blood test
研究概览
简要总结
Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis.
Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care
- •Patients with increased risk of gastric cancer (at least one of the following criteria):
- •age > 50 years,
- •family cases of gastric cancer,
- •known precancerous lesions,
- •Biermer disease,
- •H. Pylori infection,
- •genetic predisposition (ex: Lynch syndrome),
- •MALT lymphoma,
- •dyspepsia.
- •Subjects affiliated with an appropriate social security system
排除标准
- •Subjects with known active cancer
- •Pregnancy
- •Patients receiving proton-pump inhibitors
- •Conditions that may interfere with the study objectives according to the investigator
结局指标
主要结局
Sensitivity of GastroPanel blood test
时间窗: One assessment at baseline
The pepsinogen I (PGI) level measure will be compared with the gold standard method (anatomopathological examination of gastric biopsy). Results will be expressed in accordance with Sydney system. Patients will be classified as ill if PGI\<30µg/l, healthy if PGI \>=30µg/l. The sensitivity of GastroPanel test will be calculated with their 95% confidence interval.
次要结局
未报告次要终点