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临床试验/NCT05053945
NCT05053945招募中不适用

Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
260
试验地点
2
主要终点
Clinical outcomes of H. pylori patients

研究概览

简要总结

Since much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

详细描述

Helicobacter pylori is believed to affect more than half of the world's population and is thought to affect nearly 2 million people in Hong Kong alone. It is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers. Since 1994, the World Health Organization has designated H. pylori infection as a class 1 carcinogen. Gastric cancer was the sixth commonest malignancy in Hong Kong in 2015; it was also the second commonest cause of death from cancer in Asia. It is thought that chronic inflammation of the gastric mucosa caused by H. pylori progresses to pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia, before developing into frank dysplasia and carcinoma. Successful H. pylori eradication can lead to a rapid decrease in active inflammation, with early treatment effective in preventing the progression of disease. It is believed that atrophic gastritis may be reversible, whereas intestinal metaplasia has passed the point of no return and unlikely to have regression. National screening programmes in both Japan and Korea recommend endoscopy for all men and women over 40 years of age with several uncontrolled trials suggesting that this has led to a reduction of mortality due to gastric cancer. However, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective. Much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

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

入选标准

  • Adults >= 18 years of age
  • Written informed consent obtained
  • Diagnosed with current or past H. pylori infection,
  • Histologically proven atrophic gastritis (body and/or antrum of stomach), intestinal metaplasia (complete and incomplete), dysplasia (any grade) and/or gastric cancer (post- treatment)

排除标准

  • Co-morbid illness that prohibit endoscopic surveillance
  • Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol

结局指标

主要结局

Clinical outcomes of H. pylori patients

时间窗: 3 years

Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer

次要结局

  • Risk factors of gastric pre-cancerous lesions and cancers(3 years)
  • Risk factors of atrophic gastirtis(3 years)
  • Risk factors of intestinal metaplasia(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louis Ho Shing Lau

Assistant Professor

Chinese University of Hong Kong

研究点 (2)

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