Gastric NeoplasmNCT01824953
Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years
An observational study of Gastric Neoplasm and Gastric Cancer, run by Konkuk University Medical Center at 2 sites in South Korea.
Trial summary
Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Neoplasm, Gastric Cancer, Gastric Adenoma
- How many people
- 3,328 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2010to Aug 2013
- How long will I take part?
- 3 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asymptomatic Korean adults who underwent serum PG tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day at our center.
Who may be able to join
- Korean adults older than 18 year-old
- Subjects who agreed on serum pepsinogen tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day
Who cannot join
- Subjects who had past history of gastric surgery
- Abnormal endoscopic or laboratory finding that require further treatment
- Any evidence of malignancy other than gastric neoplasm
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Konkuk University Medical Center
Seoul, 143-729
Konkuk University Medical Center
Seoul
About this study
Official title: Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study
Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis. The investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the participants will be followed for an expected average of 3 years.
Read the detailed description
According to the Correa's hypothesis, the combination method using serum pepsinogen levels and serum Helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries (Korea, Japan, and China), most of the aged population are have current or had past H. pylori infection. Therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.
- Keywords
- Gastric atrophy, Helicobacter pylori, Pepsinogen, Gastric cancer, Gastric adenoma
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| atrophy-/Hp- group | Subjects without Helicobacter pylori infection and without atrophy | |
| atrophy-/Hp+ | Subjects with Helicobacter pylori infection and without atrophy | |
| atrophy+/Hp+ | Subjects with Helicobacter pylori infection and with atrophy | |
| atrophy+/Hp- | Subjects without Helicobacter pylori infection and with atrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly developed gastric neoplasm
Newly developed gastric neoplasm
Measured: December 31, 2013
Secondary outcomes (1)
Degree of gastric atrophy
Degree of gastric atrophy measured by serum pepsinogen I and II levels
Measured: December 31, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 3,328 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun-Young Lee, Konkuk University Medical Center
- Investigators
- Sun-Young Lee, MD, Principal investigator, Department of Internal Medicine, Konkuk Universtiy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824953
- Sponsor's protocol ID
- KUH1010393
- Other IDs
- 1010393, KUH 1010393
- Status last verified
- Aug 2013
- First submitted
- 28 Mar 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study
- ClinicalTrials.gov ID
- NCT01824953
- Acronym / sponsor ID
- KUH1010393
- Keywords
- Gastric atrophy, Helicobacter pylori, Pepsinogen, Gastric cancer, Gastric adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,328 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Apr 2013 (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.
Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis. The investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the participants will be followed for an expected average of 3 years.
Detailed description
According to the Correa's hypothesis, the combination method using serum pepsinogen levels and serum Helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries (Korea, Japan, and China), most of the aged population are have current or had past H. pylori infection. Therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| atrophy-/Hp- group | – | –Subjects without Helicobacter pylori infection and without atrophy |
| atrophy-/Hp+ | – | –Subjects with Helicobacter pylori infection and without atrophy |
| atrophy+/Hp+ | – | –Subjects with Helicobacter pylori infection and with atrophy |
| atrophy+/Hp- | – | –Subjects without Helicobacter pylori infection and with atrophy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic Korean adults who underwent serum PG tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day at our center.
Key inclusion criteria (2 listed)
- Korean adults older than 18 year-old
- Subjects who agreed on serum pepsinogen tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day
Key exclusion criteria (3 listed)
- Subjects who had past history of gastric surgery
- Abnormal endoscopic or laboratory finding that require further treatment
- Any evidence of malignancy other than gastric neoplasm
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
Newly developed gastric neoplasm
Time frame: December 31, 2013
Newly developed gastric neoplasm
1 secondary outcome
Degree of gastric atrophy
Time frame: December 31, 2013
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 16 Aug 2013.
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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.
Sun-Young Lee, MD principal investigator
Department of Internal Medicine, Konkuk Universtiy Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Neoplasm and Gastric Cancer, run by Konkuk University Medical Center at 2 sites 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 3 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 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Newly developed gastric neoplasm (time frame: December 31, 2013). 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 16 Aug 2013.