Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Risk stratification
研究概览
简要总结
The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered and performed endoscopic surveillance.
详细描述
Gastric cancer is still an important healthcare problem with significant mortality rates. Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less effective.
Ideally, gastric cancer could be prevented by detecting gastric precancerous conditions/lesions and identifying those individuals at high-risk of progressing to cancer to the follow-up.
Population based endoscopic screening for gastric cancer is not recommended for the early detection of gastric cancer generally deemed not to be cost-effective.
However, in the absence of screening, patients present with advanced disease, and prognosis is poor.
Targeted endoscopic surveillance strategies for gastric cancer should be introduced following the principles of the recent European guidelines: Management of precancerous conditions and lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing upper endoscopy Motivation to participate in the study Signed consent
排除标准
- •Known gastric cancer Unwillingness or inability to co-operate
结局指标
主要结局
Risk stratification
时间窗: At baseline
The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progressing to gastric cancer. The measurements for the risk stratification will be used following the updated Sydney grading and classification system e.g. degree and extent of atrophy, intestinal metaplasia and dysplasia in the stomach mucosa
次要结局
- Scheduled follow-up procedures (gastroscopies) for high risk group patients(At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion)
- Gastric, faecal microbiome in cancer patients and patients with precancerous lesions(At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion)