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

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02184910
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Duration (Months): 120
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

1. pylori eradication.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Gastritis	Drug: pepsinogen and gastrin

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 108 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Dec 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
gastritis and pepsinogen	Drug: pepsinogen and gastrin

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02184910
• Other Study ID Numbers: 4-2013-0722
• First Posted: Jul 9, 2014
• Last Update Posted: Mar 18, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Yonsei University: atrophic gastritis, pepsinogen, Helicobacter pylori
• Additional relevant MeSH terms: Gastritis; Gastritis, Atrophic; Atrophy; Gastrins

Study Results

No Results Posted as of Mar 18, 2019