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

This study has been completed.
Information provided by (Responsible Party):
Sun-Young Lee, Konkuk University Medical Center Identifier:
First received: March 28, 2013
Last updated: August 15, 2013
Last verified: August 2013
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.

Gastric Neoplasm
Gastric Cancer
Gastric Adenoma
Gastric Atrophy
Intestinal Metaplasia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study

Resource links provided by NLM:

Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • Newly developed gastric neoplasm [ Time Frame: December 31, 2013 ]
    Newly developed gastric neoplasm

Secondary Outcome Measures:
  • Degree of gastric atrophy [ Time Frame: December 31, 2013 ]
    Degree of gastric atrophy measured by serum pepsinogen I and II levels

Other Outcome Measures:
  • Helicobacter pylori [ Time Frame: December 31, 2013 ]
    Presence of Helicobacter pylori infection

Biospecimen Retention:   Samples Without DNA
Serum for Helicobacter pylori antibody and pepsinogen levels Gastric biopsy for the diagnosis of intestinal metaplasia, atrophy, inflammatory cells, Helicobacter pylori, and the presence of gastric neoplasm if any.

Enrollment: 3328
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
atrophy-/Hp- group
Subjects without Helicobacter pylori infection and without atrophy
Subjects with Helicobacter pylori infection and without atrophy
Subjects with Helicobacter pylori infection and with atrophy
Subjects without Helicobacter pylori infection and with atrophy

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic Korean adults who underwent serum PG tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day at our center.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01824953

Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Konkuk University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Konkuk University Medical Center
Principal Investigator: Sun-Young Lee, MD Department of Internal Medicine, Konkuk Universtiy Medical Center
  More Information

Responsible Party: Sun-Young Lee, Associate professor, Konkuk University Medical Center Identifier: NCT01824953     History of Changes
Other Study ID Numbers: KUH1010393  1010393  KUH 1010393 
Study First Received: March 28, 2013
Last Updated: August 15, 2013

Keywords provided by Konkuk University Medical Center:
Gastric atrophy
Helicobacter pylori
Gastric cancer
Gastric adenoma

Additional relevant MeSH terms:
Stomach Neoplasms
Gastritis, Atrophic
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes processed this record on February 20, 2017