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NCT Number: NCT06301464

Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer

The aim of this study to validate the role of pepsinogens in gastric cancer screening.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

Serum pepsinogens (PGs) are the biomarkers for gastric cancer (GC), especially atrophic gastritis which is a precursor of intestinal type GC and severe gastric inflammation which is an indicator for diffuse type GC in young age. So, test for serum PGs can be used to identify high risk patients for GC. The aim of this study is to validate the role of PGs in GC screening.

Sera and the data from esophagogastroduodenoscopy and questionnaires are collected from study subjects, and PGs and anti-H. pylori (HP) antibody are measured. Area under the curve and receiver operating characteristic curve are calculated to identify the optimal cutoff values for PGs.

To validate the usefulness of PGs to predict risk of GC, the subjects are divided into two groups based on each cut-off value for each PG value. Adjusted odds ratios (ORs) and 95% CIs are calculated using multivariate logistic regression. Risk stratification is conducted by combining each PG value and anti-HP antibody in GC subtype.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Who undergoes serum pepsinogens and anti-H. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at Seoul National University Hospital Gangnam center (SNUHGC) or Seoul National University Bundang Hospital (SNUBH)

Exclusion criteria

  • Who do not receive serum pepsinogens or anti-H. pylori antibody studies
  • Who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-H. pylori antibody tests
  • Subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment
  • Subjects with prior history of gastrectomy
  • Subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma
  • Subjects who do not agree to participate in the study or withdraw his/her consent

Treatment and study plan

Primary outcomes

  1. The level of serum pepsinogens

    Time frame: At the time of enrollment

    To compare the level of serum pepsinogens between the two groups

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Validation of Serum Pepsinogen II and Helicobacter Pylori Test in the Detection of Gastric Cancer in South Korea

Important dates

Study start
2003
Primary completion
2024
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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