Biliary Tract CancerNCT04731220
A Questionnaire Survey for Biliary Tract Cancers
An observational study of Biliary Tract Cancer, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is: To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program Development of programs by creating a multi-center biliary tract cancer registration system Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biliary Tract Cancer
- How many people
- 12,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2020to 31 Dec 2025
- 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: The study population should be defined in advance, stating eligibility criteria.
Who may be able to join
- Study population :
- Newly diagnosis of biliary tract cancers - Pathological or Radiological or other clinical diagnosis of biliary tract cancers
- Informed consent
- Control :
- with no previous cancer diagnosis
- Informed consent
Who cannot join
- Previous diagnosis of bile duct cancer with resection operation, endoscopic resection, chemotherapy or radiation therapy
- Prior diagnosis of other cancer in 5 years or ongoing cancer treatment
- Patients' refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Chilgok Hospital
Daegu, KS002
About this study
Official title: A Questionnaire Survey Study for Establishment of Surveillance and Prevention Through the Analysis of Epidemiologic Risk Factors in Patients With Biliary Tract Cancers
The purpose of this study is:
- To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program
- Development of programs by creating a multi-center biliary tract cancer registration system
- Conditions
- Biliary Tract Cancer
- Medical subject headings
- Biliary Tract Neoplasms
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 |
|---|---|---|
| Study group | Newly diagnosed as bile duct cancer | |
| Control group | No history of cancer in previous 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of cases and controls who complete each part of the study
Information is obtained by a questionnaire, laboratory findings, image data, physiological parameter.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start14 Jul 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract 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
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Hospital, Pusan National University Hospital, Pusan National University Yangsan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731220
- Sponsor's protocol ID
- KNUCH 2020-04-045
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 29 Jan 2021
- 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 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire Survey Study for Establishment of Surveillance and Prevention Through the Analysis of Epidemiologic Risk Factors in Patients With Biliary Tract Cancers
- ClinicalTrials.gov ID
- NCT04731220
- Acronym / sponsor ID
- KNUCH 2020-04-045
- Conditions
- Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Hospital, Pusan National University Hospital, Pusan National University Yangsan Hospital
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jan 2021 (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 purpose of this study is:
- To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program
- Development of programs by creating a multi-center biliary tract cancer registration system
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Newly diagnosed as bile duct cancer |
| Control group | – | –No history of cancer in previous 5 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population should be defined in advance, stating eligibility criteria.
Key inclusion criteria (6 listed)
- Study population :
- Control :
Key exclusion criteria (3 listed)
- Previous diagnosis of bile duct cancer with resection operation, endoscopic resection, chemotherapy or radiation therapy
- Prior diagnosis of other cancer in 5 years or ongoing cancer treatment
- Patients' refusal
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 and percentage of cases and controls who complete each part of the study
Time frame: 5 years
Information is obtained by a questionnaire, laboratory findings, image data, physiological parameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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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 Biliary Tract Cancer, run by Kyungpook National University Chilgok 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 6 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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?
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 and percentage of cases and controls who complete each part of the study (time frame: 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 29 Jan 2021.