Gastric CancerNCT02457624
Gastric Cancer Screening Quality Improvement System Establishment
An observational study of Gastric Cancer and Gastritis, Atrophic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Gastritis, Atrophic, Intestinal Metaplasia
- What is being tested?
- Education and feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Dec 2020
- How long will I take part?
- 6 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.
Who may be able to join
- Patients who received endoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.
Who cannot join
- Age < 18 years
- Those who refused to be included in the research
- History of gastric cancer
- Current medication with proton pump inhibitor, non-steroidal anti-inflammatory drug or aspirin
- Active/healing stage of gastric ulcer or gastric ulcer scar
- Active/healing stage of duodenal ulcer
- History of previous surgical or endoscopic resection of stomach
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Healthcare System Gangnam Center, Seoul National University Hospital
Seoul
Joo Hyun Lim, M.D., 82-2-2112-5807, joohyunlim@snuh.org
About this study
Official title: A Prospective Cohort Study for Development of Korean Gastric Cancer Prediction Model and Tailored Gastric Cancer Screening Program
Experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education.
Read the detailed description
This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods. First, the detection rate of gastric premalignant lesions and the correlation between endoscopic and serologic diagnosis of premalignant lesions will be analyzed retrospectively from March 2008 till February 2009 and from March 2013 till February 2014, when the levels of serum pepsinogen were achieved from the patients. In the second period from March 2015 till April 2015, quality assurance program will be activated. Endoscopists will be educated on the Kimura-Takemoto classification for chronic atrophic gastritis. After that their diagnosis will be tested and they will have feedback and discussion all together. In this period, inter-observer agreement rate will be assessed serially. Third, prospective trial will run from May 2015 till April 2020, in which all the endoscopists' detection rate of gastric premalignant lesion, the correlation between endoscopic and serologic diagnosis of premalignant lesions, and their inter-observer agreement will be analyzed. Finally, cumulative incidence and mortality rate of gastric cancer and incidence rate of gastric dysplasia will be investigated until December 2020.
- Conditions
- Gastric Cancer, Gastritis, Atrophic, Intestinal Metaplasia
- Being tested
- Education and feedback
- Keywords
- gastric cancer, chronic atrophic gastritis, intestinal metaplasia
- 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.
Education and feedbackBehavioural
Experienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests.
| Study group | Role | What they receive |
|---|---|---|
| Experienced endoscopists | All the experienced endoscopists will receive education and feedback on the diagnosis for premalignant lesion of chronic atrophic gastritis and intestinal metaplasia Receives: Behavioral: Education and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate for gastric premalignant lesion
Measured: 7 years
Secondary outcomes (4)
Correlation between endoscopic and serologic diagnosis of premalignant lesions
Measured: 7 years
Inter-observer agreement rate for the diagnosis of premalignant lesions
Measured: 2 months
Detection rate for gastric cancer
Measured: 7 years
Detection rate for gastric dysplasia
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMar 2008
- Primary completionApr 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 17 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Chung, Seoul National University Hospital
- Investigators
- Su Jin Chung, MD.PhD., Principal investigator, Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457624
- Sponsor's protocol ID
- 1503-044-655
- Status last verified
- Apr 2016
- First submitted
- 25 Mar 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study for Development of Korean Gastric Cancer Prediction Model and Tailored Gastric Cancer Screening Program
- ClinicalTrials.gov ID
- NCT02457624
- Acronym / sponsor ID
- 1503-044-655
- Conditions
- Gastric Cancer, Gastritis, Atrophic, Intestinal Metaplasia
- Keywords
- gastric cancer, chronic atrophic gastritis, intestinal metaplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 May 2015 (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.
Experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education.
Detailed description
This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods. First, the detection rate of gastric premalignant lesions and the correlation between endoscopic and serologic diagnosis of premalignant lesions will be analyzed retrospectively from March 2008 till February 2009 and from March 2013 till February 2014, when the levels of serum pepsinogen were achieved from the patients. In the second period from March 2015 till April 2015, quality assurance program will be activated. Endoscopists will be educated on the Kimura-Takemoto classification for chronic atrophic gastritis. After that their diagnosis will be tested and they will have feedback and discussion all together. In this period, inter-observer agreement rate will be assessed serially. Third, prospective trial will run from May 2015 till April 2020, in which all the endoscopists' detection rate of gastric premalignant lesion, the correlation between endoscopic and serologic diagnosis of premalignant lesions, and their inter-observer agreement will be analyzed. Finally, cumulative incidence and mortality rate of gastric cancer and incidence rate of gastric dysplasia will be investigated until December 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced endoscopists | – | Behavioral: Education and feedbackAll the experienced endoscopists will receive education and feedback on the diagnosis for premalignant lesion of chronic atrophic gastritis and intestinal metaplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.
Key inclusion criteria (1 listed)
- Patients who received endoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.
Key exclusion criteria (7 listed)
- Age < 18 years
- Those who refused to be included in the research
- History of gastric cancer
- Current medication with proton pump inhibitor, non-steroidal anti-inflammatory drug or aspirin
- Active/healing stage of gastric ulcer or gastric ulcer scar
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 |
|---|---|---|
| Education and feedbackExperienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests. | Behavioural | Experienced endoscopists |
Primary outcome
Detection rate for gastric premalignant lesion
Time frame: 7 years
4 secondary outcomes
Correlation between endoscopic and serologic diagnosis of premalignant lesions
Time frame: 7 years
Inter-observer agreement rate for the diagnosis of premalignant lesions
Time frame: 2 months
Detection rate for gastric cancer
Time frame: 7 years
Detection rate for gastric dysplasia
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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.
Su Jin Chung, MD.PhD. principal investigator
Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National 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 Gastric Cancer and Gastritis, Atrophic, run by Seoul National 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 1 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 Apr 2016. 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 Joo Hyun Lim, MD. (+82-02-2112-5807, limz00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate for gastric premalignant lesion (time frame: 7 years). 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 Apr 2016.