Risk FactorNCT03059732
Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan
An observational study of Risk Factor, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk Factor
- What is being tested?
- Treatment
- How many people
- 700 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2016to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014 in King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan.
Who may be able to join
- all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.
Who cannot join
- Age < 18 years
- Incomplete data
- Miss diagnosis of gastric adenocarcinoma
- Died from other causes (not related to gastric adenocarcinoma).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Bangkok, Patum Wan, 10330
About this study
The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Therefore, this study aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors associated with different outcome in Thailand and Japan to find a clue to improve patients' survival in low prevalence country such as Thailand.
This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan. Eligible cases were selected by using standardized search protocols: formal computer searches of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.Two physicians, who were informed the definition of each variable, individually reviewed chart of patients.
- Conditions
- Risk Factor
- Being tested
- Treatment
- Keywords
- Gastric cancer, Thailand, Japan
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Observe the treatments of gastric cancer in each group
| Study group | Role | What they receive |
|---|---|---|
| Thailand | Thai patients who diagnosed gastric cancer Receives: Other: Treatment | |
| Japan | Japanese patients who diagnosed gastric cancer Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors that associated with mortality rate in Thailand compared to Japan
Measured: 2010-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Dec 2016
- Primary completion28 Feb 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk FactorStudies 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Responsible party
- Principal investigator, Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059732
- Sponsor's protocol ID
- 029/59
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan
- ClinicalTrials.gov ID
- NCT03059732
- Acronym / sponsor ID
- 029/59
- Conditions
- Risk Factor
- Keywords
- Gastric cancer, Thailand, Japan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Collaborators
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 23 Feb 2017 (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.
The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Therefore, this study aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors associated with different outcome in Thailand and Japan to find a clue to improve patients' survival in low prevalence country such as Thailand.
This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan. Eligible cases were selected by using standardized search protocols: formal computer searches of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.Two physicians, who were informed the definition of each variable, individually reviewed chart of patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thailand | – | Other: TreatmentThai patients who diagnosed gastric cancer |
| Japan | – | Other: TreatmentJapanese patients who diagnosed gastric cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014 in King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan.
Key inclusion criteria (1 listed)
- all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.
Key exclusion criteria (4 listed)
- Age < 18 years
- Incomplete data
- Miss diagnosis of gastric adenocarcinoma
- Died from other causes (not related to gastric adenocarcinoma).
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 |
|---|---|---|
| TreatmentObserve the treatments of gastric cancer in each group | Other | Japan, Thailand |
Primary outcome
Factors that associated with mortality rate in Thailand compared to Japan
Time frame: 2010-2014
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 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Risk Factor, 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 1 inclusion and 4 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 Feb 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 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?
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?
Factors that associated with mortality rate in Thailand compared to Japan (time frame: 2010-2014). 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 Feb 2019.