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Completed

NCT Number: NCT01824953

Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years

Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis. The investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the participants will be followed for an expected average of 3 years.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konkuk University Medical Center, Seoul, South Korea

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About this study

According to the Correa's hypothesis, the combination method using serum pepsinogen levels and serum Helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries (Korea, Japan, and China), most of the aged population are have current or had past H. pylori infection. Therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Korean adults older than 18 year-old
  • Subjects who agreed on serum pepsinogen tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day

Exclusion criteria

  • Subjects who had past history of gastric surgery
  • Abnormal endoscopic or laboratory finding that require further treatment
  • Any evidence of malignancy other than gastric neoplasm

Treatment and study plan

Primary outcomes

  1. Newly developed gastric neoplasm

    Time frame: December 31, 2013

    Newly developed gastric neoplasm

Secondary outcomes

  1. Degree of gastric atrophy

    Time frame: December 31, 2013

    Degree of gastric atrophy measured by serum pepsinogen I and II levels

Other outcomes

  1. Helicobacter pylori

    Time frame: December 31, 2013

    Presence of Helicobacter pylori infection

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Aug 16, 2013

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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