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

NCT02184910 | Unknown

• 1 other identifier: 4-2013-0722
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophic Gastritis

Keywords

atrophic gastritis, pepsinogen, Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• the change of pepsinogen level before and after H. pylori eradication

  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

Study Arms (1)

gastritis and pepsinogen

Drug: pepsinogen and gastrin

Interventions

pepsinogen and gastrin DRUG

gastritis and pepsinogen

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic

Interventions

Pepsinogen A; Gastrins

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Pepsinogens; Enzyme Precursors; Enzymes and Coenzymes; Protein Precursors; Proteins; Amino Acids, Peptides, and Proteins; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Nerve Tissue Proteins

Central Study Contacts

Yong Chan Lee, MD, PhD

CONTACT

82-2-2228-1960; leeyc@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 9, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

KR (1)