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

NCT ID: NCT01824953

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Gastric Neoplasm Gastric Cancer Gastric Adenoma Gastric Atrophy Intestinal Metaplasia

Keywords

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Gastric atrophy Helicobacter pylori Pepsinogen Gastric cancer Gastric adenoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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atrophy-/Hp- group

Subjects without Helicobacter pylori infection and without atrophy

No interventions assigned to this group

atrophy-/Hp+

Subjects with Helicobacter pylori infection and without atrophy

No interventions assigned to this group

atrophy+/Hp+

Subjects with Helicobacter pylori infection and with atrophy

No interventions assigned to this group

atrophy+/Hp-

Subjects without Helicobacter pylori infection and with atrophy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sun-Young Lee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sun-Young Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Konkuk Universtiy Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1010393

Identifier Type: OTHER

Identifier Source: secondary_id

KUH 1010393

Identifier Type: OTHER

Identifier Source: secondary_id

KUH1010393

Identifier Type: -

Identifier Source: org_study_id