Gallbladder CancerNCT02326948
Alcohol Consumption and Gallbladder Cancer
An observational study of Gallbladder Cancer, run by Cheju Halla General Hospital at 1 site in South Korea.
Trial summary
This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallbladder Cancer
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Nov 2014
- 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: Case group was defined as the patients newly diagnosed GBC at the Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea, during 2008 - 2013. And control groups were determined the randomly 1:1 matched subjects by the age and sex distributions of GBC cases, among the health care check-up examinees visited to Health Promotion Center in the same institute and same periods. Total 78 cases among 124 GBC patients and matched 78 controls from 7088 health check-up examinees were included this study.
Who may be able to join
- Case group : newly diagnosed gallbladder cancer patients in Digestive Disease Center, Department of Internal Medicine in Cheju Halla General Hospitalduring 2008-2013
- Control group : 1:1 age-sex matched controls underwent health care screening program in Department of Health Promotion Center in Cheju Halla General Hospital for 2008-2012.
Who cannot join
- Case group Ambiguous diagnosis primary tumor involving common bile duct follow up loss without pathologic confirmation Incomplete clinical records Couldn't be assessed the results of operation or radiologic imaging.
- Control group Cases unavailable for gallbladder imaging (abdominal ultrasonography ,computed tomography, or magnetic resonance imaging) Cases underwent previous cholecystectomy before enrollment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cheju Halla General Hopsital
Jeju City, Jeju Special Governing Province, 670-744
About this study
Official title: Alcohol Consumption and Gallbladder Cancer: Case-control Study in Jeju Island, Korea.
This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea.
Read the detailed description
In order to estimate region-specific risk factors for gallbladder cancer (GBC) in Jeju island, Korea the investigators performed a case-control study. Among 124 GBC patients and 7088 health controls, the investigators randomly selected 78 cases and 78 age-sex matched controls (1:1 matching) and compared their demographic features, combined diseases, and personal histories about known risk factors until now.
- Conditions
- Gallbladder Cancer
- Keywords
- Gallbladder cancer, Case-control study, Risk factor, Alcohol consumption, Polypoid lesions of gallbladder, Biliary stone
- Medical subject headings
- Gallbladder Neoplasms, Alcohol Drinking, Cholecystolithiasis
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 |
|---|---|---|
| Gallbladder cancer case group | Gallbladder cancer case group was defined as newly diagnosed gallbladder cancer diagnosed as GBC at the Department of Internal Medicine in Cheju Halla General Hospital, Jeju, Korea from 2009 to 2013. | |
| Age and sex matched control group | Age and sex matched control group was determined as age-sex matched subjects selected from the participants of Health Promotion Center in the same institute from 2009 to 2012. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with alcohol consumption
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies 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
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheju Halla General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung Hyo Cha, MD, Cheju Halla General Hospital
- Investigators
- Byung Hyo Cha, M.D., Principal investigator, Director of Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326948
- Sponsor's protocol ID
- 2014-L04
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Consumption and Gallbladder Cancer: Case-control Study in Jeju Island, Korea.
- ClinicalTrials.gov ID
- NCT02326948
- Acronym / sponsor ID
- 2014-L04
- Conditions
- Gallbladder Cancer
- Keywords
- Gallbladder cancer, Case-control study, Risk factor, Alcohol consumption, Polypoid lesions of gallbladder, Biliary stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Cheju Halla General HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Dec 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.
This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea.
Detailed description
In order to estimate region-specific risk factors for gallbladder cancer (GBC) in Jeju island, Korea the investigators performed a case-control study. Among 124 GBC patients and 7088 health controls, the investigators randomly selected 78 cases and 78 age-sex matched controls (1:1 matching) and compared their demographic features, combined diseases, and personal histories about known risk factors until now.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gallbladder cancer case group | – | –Gallbladder cancer case group was defined as newly diagnosed gallbladder cancer diagnosed as GBC at the Department of Internal Medicine in Cheju Halla General Hospital, Jeju, Korea from 2009 to 2013. |
| Age and sex matched control group | – | –Age and sex matched control group was determined as age-sex matched subjects selected from the participants of Health Promotion Center in the same institute from 2009 to 2012. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Case group was defined as the patients newly diagnosed GBC at the Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea, during 2008 - 2013. And control groups were determined the randomly 1:1 matched subjects by the age and sex distributions of GBC cases, among the health care check-up examinees visited to Health Promotion Center in the same institute and same periods. Total 78 cases among 124 GBC patients and matched 78 controls from 7088 health check-up examinees were included this study.
Key inclusion criteria (2 listed)
- Case group : newly diagnosed gallbladder cancer patients in Digestive Disease Center, Department of Internal Medicine in Cheju Halla General Hospitalduring 2008-2013
- Control group : 1:1 age-sex matched controls underwent health care screening program in Department of Health Promotion Center in Cheju Halla General Hospital for 2008-2012.
Key exclusion criteria (2 listed)
- Case group Ambiguous diagnosis primary tumor involving common bile duct follow up loss without pathologic confirmation Incomplete clinical records Couldn't be assessed the results of operation or radiologic imaging.
- Control group Cases unavailable for gallbladder imaging (abdominal ultrasonography ,computed tomography, or magnetic resonance imaging) Cases underwent previous cholecystectomy before enrollment.
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
Number of participants with alcohol consumption
Time frame: Up to 3 years
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 30 Dec 2014.
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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.
Byung Hyo Cha, M.D. principal investigator
Director of Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital, Korea
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 Gallbladder Cancer, run by Cheju Halla General 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 2 inclusion and 2 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 30 Dec 2014. 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?
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?
Number of participants with alcohol consumption (time frame: Up to 3 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 30 Dec 2014.