Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Incidence of gastric cancer or high grade dysplasia of the gastric mucosa
研究概览
简要总结
This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.
As secondary objectives, among the patients included in the cohort, the study will:
- assess the incidence of low grade dysplasia,
- assess the incidence of high grade dysplasia in patients with low grade dysplasia,
- identify risk factors of progression to dysplasia and gastric cancer.
详细描述
This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.
All patients will undergo an endoscopy with gastric sampling in order to biopsy:
- 1 sample each in anterior and posterior surfaces of antrum
- 1 sample in lesser curvature
- 1 sample each in anterior and posterior surfaces of body of stomach
Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.
During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:
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
- 否
入选标准
- •Age > 18 years.
- •Gastroscopic examination with biopsy in the 6 months preceding inclusion, with intestinal metaplasia in body of stomach or angular incisure.
- •Patient does not oppose to participate to the study.
排除标准
- •Progressive concomitant disease with life expectancy less than 3 years.
- •Gastric cancer at the time of inclusion.
- •Patient with previous oesophageal cancer.
- •Patient with previous gastric surgery.
- •Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).
结局指标
主要结局
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa
时间窗: 3 years
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.
次要结局
- Percentage of development of low grade dysplasia(3 years)
- Percentage of development of gastric cancer or high grade dysplasia(3 years)