Gastric Intestinal MetaplasiaNCT01490541
The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population
An observational study of Gastric Intestinal Metaplasia, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population. Objective: To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Intestinal Metaplasia
- How many people
- 280 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2011to Oct 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All GIM patients in KCMH whose diagnosed from 1997 to 2005, at least 280.
Who may be able to join
- All patients were diagnosed GIM
- All patients have to sign the consent form
Who cannot join
- Previous gastric surgery including gastrectomy and bypass surgery
- Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
- HIV infection
- History of proton pump inhibitor use within 1 week
- History of antibiotic use within 4 weeks
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rapat Pittayanon
Bangkok, Bangkok, 10330
Rapat Pittayanon, MD, 66813132112, rapat125@gmail.com
Nuttapaht Namjud, M.Sc, 66894971957, ampere_nut@hotmail.com
About this study
The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population.
Objective:
To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people.
Research Design:
Single center, retrospective-cohort study.
Read the detailed description
Study population and Sample size at Faculty of Medicine, Chulalongkorn University The patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. Estimate sample size =280
- Investigational product, dosage \& route of administration
- Questionnaire for explore the risk factors
- EGD with biopsy
- Blood sampling for gastro panel
- Duration of participation
- 5 years or until diagnose gastric cancer
Statistical method:
Unconditional-binary-logistic regression
- Conditions
- Gastric Intestinal Metaplasia
- Keywords
- Gastric intestinal metaplasia
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 |
|---|---|---|
| Gastric intestinal metaplasia patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population
In Thailand, gastric cancer patients usually presented with advance stage and carried the dismal prognosis. GIM is a well known precancerous lesion. The appropriate follow-up period in high risk GIM patient can increase the prevalence of early gastric cancer and reduce the mortality rate of gastric cancer
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
- Investigators
- Rungsun Rerknimitr, Professor, Study director, King Chulalongkorn Memorial HospitalRapat Pittayanon, MD, Principal investigator, King Chulalongkron Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490541
- Sponsor's protocol ID
- RP003
- Status last verified
- Jun 2012
- First submitted
- 5 Dec 2011
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population
- ClinicalTrials.gov ID
- NCT01490541
- Acronym / sponsor ID
- RP003
- Conditions
- Gastric Intestinal Metaplasia
- Keywords
- Gastric intestinal metaplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 13 Dec 2011 (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.
The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population.
Objective:
To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people.
Research Design:
Single center, retrospective-cohort study.
Detailed description
Study population and Sample size at Faculty of Medicine, Chulalongkorn University The patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. Estimate sample size =280
- Investigational product, dosage \& route of administration
- Questionnaire for explore the risk factors
- EGD with biopsy
- Blood sampling for gastro panel
- Duration of participation
- 5 years or until diagnose gastric cancer
Statistical method:
Unconditional-binary-logistic regression
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric intestinal metaplasia patient | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All GIM patients in KCMH whose diagnosed from 1997 to 2005, at least 280.
Key inclusion criteria (2 listed)
- All patients were diagnosed GIM
- All patients have to sign the consent form
Key exclusion criteria (5 listed)
- Previous gastric surgery including gastrectomy and bypass surgery
- Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
- HIV infection
- History of proton pump inhibitor use within 1 week
- History of antibiotic use within 4 weeks
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
The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population
Time frame: Up to 5 years
In Thailand, gastric cancer patients usually presented with advance stage and carried the dismal prognosis. GIM is a well known precancerous lesion. The appropriate follow-up period in high risk GIM patient can increase the prevalence of early gastric cancer and reduce the mortality rate of gastric cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Ethic committee of KCMHLink provided by the sponsor.
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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.
Rungsun Rerknimitr, Professor study director
King Chulalongkorn Memorial Hospital
Rapat Pittayanon, MD principal investigator
King Chulalongkron Memorial 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 Intestinal Metaplasia, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 5 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 25 Jun 2012. 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 Thailand. 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 Rapat Pittayanon, MD (66813132112, Rapat125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population (time frame: Up to 5 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 25 Jun 2012.