A Questionnaire Survey for Biliary Tract Cancers

January 28, 2021 updated by: Kyungpook National University Chilgok Hospital

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

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Anticipated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, KS002
        • Kyungpook National University Chilgok Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population should be defined in advance, stating eligibility criteria.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study group
Newly diagnosed as bile duct cancer
Control group
No history of cancer in previous 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Chilgok Hospital

Collaborators

Pusan National University Hospital
Kyungpook National University Hospital
Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUCH 2020-04-045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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