Usefulness of Serum Pepsinogen and Gastrin as the Predictive Biomarker of Atrophic Gastritis, Intestinal Metaplasia and Gastric Cancer in Korea

March 14, 2019 updated by: Yonsei University
It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for atrophic gastritis and whether gastric atrophy based on the PG test would be improved after H. pylori eradication.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yong Chan Lee, MD, PhD
  • Phone Number: 82-2-2228-1960
  • Email: leeyc@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
          • Yong Chan Lee, MD, PhD
          • Phone Number: 82-2-2228-1960
          • Email: leeyc@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Over 19 years, the patients who have gastrointestinal discomfort or get esophagastroduodenoscopy (EGD) for health check up, the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer

Description

Inclusion Criteria:

  1. over 19 years
  2. the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy (EGD) for health check up
  3. the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer

Exclusion Criteria:

  1. gastrectomy history
  2. advanced gastric cancer (impossible to get the gastrectomy)
  3. Helicobacter eradication history
  4. the patients who have chronic disease
  5. cancer patients except gastric cancer within 6 months
  6. who cannot perform this study according to research's decision
  7. who have bleeding tendency (ex. taking antiplatelet agent, low platelet count or abnormal coagulation time)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
gastritis and pepsinogen
Drug: pepsinogen and gastrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of pepsinogen level before and after H. pylori eradication
Time Frame: baseline and 6 months
to compare the change of the pepsinogen level before and after H. pylori eradication and evaluate the correlation between the pepsinogen level and the atrophic gastritis
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0722

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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