A Questionnaire Survey for Biliary Tract Cancers | NCT04731220

Studies
A Questionnaire Survey for Biliary Tract Cancers

NCT04731220

Sponsor

Kyungpook National University Chilgok Hospital

Status

Unknown status

Last Update Posted

Jan 29, 2021Actual

Enrollment

12,000Estimated

Phase

Not provided

Conditions

Biliary Tract Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2020Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 20, 2021

First Submission Date that Met QC Criteria

Jan 28, 2021

First Posted Date

Jan 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2021

Last Update Posted Date

Jan 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Kyungpook National University Chilgok HospitalOTHER

Collaborators

Name	Class
Kyungpook National University Hospital	OTHER
Pusan National University Hospital	OTHER
Pusan National University Yangsan Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Newly diagnosed as bile duct cancer
Control group		No history of cancer in previous 5 years

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Chilgok Hospital		Daegu		KS002	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001661	Biliary Tract Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided