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


N/A
18 Years
90 Years
Open (Enrolling)
Both
Gastric Neoplasm, Gastric Cancer, Gastric Adenoma, Gastric Atrophy, Intestinal Metaplasia

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Trial Information

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


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Newly developed gastric neoplasm

Outcome Description:

Newly developed gastric neoplasm

Outcome Time Frame:

December 31, 2013

Safety Issue:

No

Principal Investigator

Sun-Young Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine, Konkuk Universtiy Medical Center

Authority:

Korea: Institutional Review Board

Study ID:

KUH1010393

NCT ID:

NCT01824953

Start Date:

January 2010

Completion Date:

December 2014

Related Keywords:

  • Gastric Neoplasm
  • Gastric Cancer
  • Gastric Adenoma
  • Gastric Atrophy
  • Intestinal Metaplasia
  • Gastric atrophy
  • Helicobacter pylori
  • Pepsinogen
  • Gastric cancer
  • Gastric adenoma
  • Adenoma
  • Neoplasms
  • Gastritis
  • Gastritis, Atrophic
  • Stomach Neoplasms
  • Metaplasia
  • Atrophy

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