NCT04037904

Brief Summary

We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

15.9 years

First QC Date

July 28, 2019

Last Update Submit

April 12, 2023

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriInterleukin-1 betaGastric H+, K+- APTase

Outcome Measures

Primary Outcomes (1)

  • Interleukin-1B and H+,K+-ATPase mRNA expression

    Gastric Interleukin-1B and H+,K+-ATPase mRNA expression in subjects with and without H. pylori infection at baseline, and changes of Interleukin-1B and H+,K+-ATPase mRNA expression with time in subjects without H. pylori infection and subjects who underwent H. pylori eradication successfully. Gastric Interleukin-1B and H+,K+-ATPase mRNA expression measured by reverse transcription polymerase chain reaction, using the gastric mucosa specimen obtained during esophagogastroduodenoscopy

    1 year

Study Arms (2)

H. pylori negative group

Subjects who have not have H. pylori infection, and had not receive H. pylori eradication

H. pylorieradicated group

Subjects who have had H. pylori infection currently and received successful H. pylori eradication according to appropriated indication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Controls and patients with gastric dysplasia or gastric cancer who received esophagogastroduodenoscopy and underwent H. pylori tests

You may qualify if:

  • Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy
  • Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report

You may not qualify if:

  • Subjects with previous eradication treatment for H. pylori
  • Subjects with previous gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2019

First Posted

July 30, 2019

Study Start

February 1, 2006

Primary Completion

January 1, 2022

Study Completion

December 1, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

KR(1)