Clinical trial NCT01824953: Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years
Official title: Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Neoplasm
Gastric Cancer
Gastric Adenoma
Gastric Atrophy
Intestinal Metaplasia
Keywords: Gastric atrophy
Helicobacter pylori
Pepsinogen
Gastric cancer
Gastric adenoma
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 3328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Newly developed gastric neoplasm
timeFrame: December 31, 2013
Secondary outcomes:
measure: Degree of gastric atrophy
timeFrame: December 31, 2013
Other outcomes:
measure: Helicobacter pylori
timeFrame: December 31, 2013
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Department of Internal Medicine, Konkuk Universtiy Medical Center
name: Sun-Young Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: