Atrophic GastritisNCT02184910
Usefulness of Serum Pepsinogen and Gastrin as the Predictive Biomarker of Atrophic Gastritis, Intestinal Metaplasia and Gastric Cancer in Korea
An observational study of Atrophic Gastritis, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Atrophic Gastritis
- What is being tested?
- pepsinogen and gastrin
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2023
- How long will I take part?
- 4 Years
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Over 19 years, the patients who have gastrointestinal discomfort or get esophagastroduodenoscopy (EGD) for health check up, the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer
Who may be able to join
- over 19 years
- the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy (EGD) for health check up
- the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer
Who cannot join
- gastrectomy history
- advanced gastric cancer (impossible to get the gastrectomy)
- Helicobacter eradication history
- the patients who have chronic disease
- cancer patients except gastric cancer within 6 months
- who cannot perform this study according to research's decision
- who have bleeding tendency (ex. taking antiplatelet agent, low platelet count or abnormal coagulation time)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 120-752
Yong Chan Lee, MD, PhD, 82-2-2228-1960, leeyc@yuhs.ac
About this study
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 H. pylori eradication.
- Conditions
- Atrophic Gastritis
- Being tested
- pepsinogen and gastrin
- Keywords
- atrophic gastritis, pepsinogen, Helicobacter pylori
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pepsinogen and gastrinDrug
| Study group | Role | What they receive |
|---|---|---|
| gastritis and pepsinogen | Not described Receives: Drug: pepsinogen and gastrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of pepsinogen level before and after H. pylori eradication
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
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic GastritisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184910
- Sponsor's protocol ID
- 4-2013-0722
- Status last verified
- Mar 2019
- First submitted
- 4 Jul 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Serum Pepsinogen and Gastrin as the Predictive Biomarker of Atrophic Gastritis, Intestinal Metaplasia and Gastric Cancer in Korea
- ClinicalTrials.gov ID
- NCT02184910
- Acronym / sponsor ID
- 4-2013-0722
- Conditions
- Atrophic Gastritis
- Keywords
- atrophic gastritis, pepsinogen, Helicobacter pylori
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- 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.
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 H. pylori eradication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastritis and pepsinogen | – | Drug: pepsinogen and gastrin |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 19 years, the patients who have gastrointestinal discomfort or get esophagastroduodenoscopy (EGD) for health check up, the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer
Key inclusion criteria (3 listed)
- over 19 years
- the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy (EGD) for health check up
- the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer
Key exclusion criteria (7 listed)
- gastrectomy history
- advanced gastric cancer (impossible to get the gastrectomy)
- Helicobacter eradication history
- the patients who have chronic disease
- cancer patients except gastric cancer within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pepsinogen and gastrin | Drug | gastritis and pepsinogen |
Primary outcome
the change of pepsinogen level before and after H. pylori eradication
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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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.
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 Atrophic Gastritis, run by Yonsei University 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Chan Lee, MD, PhD (82-2-2228-1960, leeyc@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of pepsinogen level before and after H. pylori eradication (time frame: baseline and 6 months). 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 18 Mar 2019.