Helicobacter Pylori EradicationNCT03924375
Serum Pepsinogen After H. Pylori Eradication
An observational study of Helicobacter Pylori Eradication, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Helicobacter Pylori Eradication
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2019to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Gastroscopy can be performed
- Serologic markers including serum pepsinogen can be measured
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, 04401
About this study
Official title: Serum Pepsinogen After Helicobacter Pylori Eradication for the Gastric Cancer Prevention
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.
Read the detailed description
This study aimed to evaluate the change of serum PGs after H. pylori eradication success and identify the optimal timing of eradication.
- Conditions
- Helicobacter Pylori Eradication
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum pepsinogen change after H. pylori eradication
Serum pepsinogen recovery
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start15 Mar 2019
- Primary completion15 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Jun-Hyung, M.D., Principal investigator, Digestive Disease Center, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924375
- Sponsor's protocol ID
- SCH-HP-2019
- Status last verified
- Jul 2020
- First submitted
- 20 Apr 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Pepsinogen After Helicobacter Pylori Eradication for the Gastric Cancer Prevention
- ClinicalTrials.gov ID
- NCT03924375
- Acronym / sponsor ID
- SCH-HP-2019
- Conditions
- Helicobacter Pylori Eradication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Gastroscopy can be performed
- Serologic markers including serum pepsinogen can be measured
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum pepsinogen change after H. pylori eradication
Time frame: after 8 weeks
Serum pepsinogen recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Hyung Jun-Hyung, M.D. principal investigator
Digestive Disease Center, Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Eradication, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum pepsinogen change after H. pylori eradication (time frame: after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.