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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824953
• Other study ID #: KUH1010393
• Secondary ID: 1010393KUH 10103
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: August 15, 2013
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3328
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Adenoma
• Gastric Atrophy
• Gastric Cancer
• Gastric Neoplasm
• Gastritis, Atrophic
• Intestinal Metaplasia
• Metaplasia
• Stomach Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Helicobacter pylori	Presence of Helicobacter pylori infection	December 31, 2013	No
Primary	Newly developed gastric neoplasm	Newly developed gastric neoplasm	December 31, 2013	No
Secondary	Degree of gastric atrophy	Degree of gastric atrophy measured by serum pepsinogen I and II levels	December 31, 2013	No