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临床试验/NCT05883345
NCT05883345已完成不适用

Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric Neoplasms

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 1,490 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,490
试验地点
1
主要终点
Significant Blood Test Findings Correlated With Gastric Neoplasms

研究概览

简要总结

Helicobacter pylori infection rate is decreasing in younger population; however, biennial gastroscopy is still recommended for all Koreans aged between 40 and 75 years. This study aimed to validate blood tests for gastric cancer screening according to the infection status of H. pylori (naive, current, and past infection).

详细描述

Helicobacter pylori-seropositive rates are decreasing in South Korea. Seroprevalence was 74.3% in 1990, but it decreased to 43.9% in 2016. In Koreans, most gastric cancers are related to H. pylori infection. H. pylori-negative gastric cancers were found only in 2.3% among the 1,833 Korean gastric cancer patients. Despite these facts, the national guideline still recommends biennial gastroscopy for all Koreans aged between 40 and 75 years. Therefore, 8,462,570 (63.1%) Koreans underwent gastric cancer screening among the target population of 13,404,927 individuals in 2021.

In H. pylori-seroprevalent populations, diagnostic criteria for naive status should be strict based on histology, endoscopy, and serum pepsinogen (PG) assay findings. Naive condition should be diagnosed only when both invasive and non-invasive H. pylori tests show negative findings. Furthermore, there should be no intestinal metaplasia and atrophy on serum PG assay, endoscopy, and histology findings in H. pylori-naive participants. Based on those findings, H. pylori infection will be confirmed when invasive tests or urea breath test was positive. H. pylori-naive status will be diagnosed if there was no eradication history, no serologically detected atrophy (PG I ≤70 ng/mL and PG I/II ≤3), and no intestinal metaplasia or atrophy on endoscopy and histology.

This study aimed to determine the validity of blood tests for gastric cancer screening according to the H. pylori infection status. We tried to identify significant variables using GastroPanel tests and traditional serum PG assays in patients with gastric neoplasms.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who visited for gastric cancer screening

排除标准

  • History of gastrectomy
  • Renal insufficiency
  • Severe comorbidities requiring prompt management

结局指标

主要结局

Significant Blood Test Findings Correlated With Gastric Neoplasms

时间窗: 15 months

Serum pepsinogen I/II ratios indicating the presence gastric neoplasms (Minimum and maximum ratios were 0.2 and 19.1, respectively. Lower ratios indicate worse outcome.)

次要结局

  • Test Findings Correlated With the Presence of Gastric Neoplasms(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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