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临床试验/NCT04989153
NCT04989153Unknown不适用

China Health Promotion Foundation/the Second Affiliated Hospital of Zhejiang University, School of Medicine

Second Affiliated Hospital, School of Medicine, Zhejiang University9 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2016年3月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
试验地点
9
主要终点
serum pepsinogen levels for GC and precancerous lesions

研究概览

简要总结

Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China.

详细描述

Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China. We operated a multicenter cross-sectional study of subjects who underwent health checkup at nine International Healthcare Centers in China. All participants underwent gastroscopy and pathological examination, serum PG, 13C-urea breath test, and/or Hp serological current infection marker rapid test, all on the same day. PG related parameters were analyzed in different Hp subgroups and regions.

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
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • intention to undergo gastroscopy during health checkup examination 25-75 years of age.

排除标准

  • a history of gastric ulcer, gastric polyp, or GC a history of gastrectomy treatment with a proton pump inhibitor in the last month contraindications to gastroscopy a history of Hp eradication a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month incomplete data.

结局指标

主要结局

serum pepsinogen levels for GC and precancerous lesions

时间窗: 1 year

cutoff values of pepsinogen level for GC and precancerous lesions in different regions in China and in different HP status

Risk factors for GC

时间窗: 1 year

the risk factors for GC, according to the logistic regression model

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (9)

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