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Serum Pepsinogen After H. Pylori Eradication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924375
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Jun-Hyung Cho, Soonchunhyang University Hospital

Study Description
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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.

Condition or disease
Helicobacter Pylori Eradication

Detailed Description:
This study aimed to evaluate the change of serum PGs after H. pylori eradication success and identify the optimal timing of eradication.
Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Serum Pepsinogen After Helicobacter Pylori Eradication for the Gastric Cancer Prevention
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : May 31, 2020

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Serum pepsinogen change after H. pylori eradication [ Time Frame: after 8 weeks ]
    Serum pepsinogen recovery


Biospecimen Retention:   Samples Without DNA
Biospecimen would be obtained for urease test (commercial name: CLOtest).

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924375


Locations
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Korea, Republic of
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, Korea, Republic of, 04401
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Jun-Hyung Jun-Hyung, M.D. Digestive Disease Center, Soonchunhyang University Hospital
More Information
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Responsible Party: Jun-Hyung Cho, Associate Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT03924375    
Other Study ID Numbers: SCH-HP-2019
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No