NCT04731220

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

4.5 years

First QC Date

January 20, 2021

Last Update Submit

January 28, 2021

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Study Arms (2)

Study group

Newly diagnosed as bile duct cancer

Control group

No history of cancer in previous 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, KS002, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 29, 2021

Study Start

July 14, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

KR(1)