NCT03924375

Brief Summary

Helicobacter pylori has been recognized as a major pathogen in gastric carcinogenesis. Current guidelines recommend the H. pylori "test-and-treat" strategy for the purpose of primary and secondary gastric cancer prevention. Considering the "point of no return" theory, however, H. pylori eradication cannot reduce the risk of gastric cancer in subjects with gastric atrophy and intestinal metaplasia. The intragastric hypoacidic environment is associated with the risk of intestinal-type gastric cancer development. Recently, the secretory ability of the stomach can be measured using the serum pepsinogen (PG) assay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

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

March 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

April 20, 2019

Last Update Submit

July 24, 2020

Conditions

Helicobacter Pylori Eradication

Outcome Measures

Primary Outcomes (1)

  • Serum pepsinogen change after H. pylori eradication

    Serum pepsinogen recovery

    after 8 weeks

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

H. pylori-infected subjects who underwent an upper gastrointestinal endoscopy were enrolled in this study at a single, tertiary-care, academic medical center.

You may qualify if:

  • Gastroscopy can be performed
  • Serologic markers including serum pepsinogen can be measured

You may not qualify if:

  • Age \< 20 or \> 70 years
  • Anemia (serum hemoglobin level \< 10 g/dL)
  • Severe systemic disease
  • Advanced chronic liver disease
  • Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
  • History of H. pylori eradication
  • History of gastric surgery
  • Recent history of upper gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen would be obtained for urease test (commercial name: CLOtest).

Study Officials

  • Jun-Hyung Jun-Hyung, M.D.

    Digestive Disease Center, Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2019

First Posted

April 23, 2019

Study Start

March 15, 2019

Primary Completion

March 15, 2020

Study Completion

May 31, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)