Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk | NCT02193464

Studies
Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk

NCT02193464

Sponsor

Kyungpook National University Hospital

Status

Recruiting

Last Update Posted

Jan 12, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Idiopathic Chronic Inflammatory Bowel Disease

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

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jul 16, 2014

First Submission Date that Met QC Criteria

Jul 16, 2014

First Posted Date

Jul 17, 2014Estimated

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 8, 2021

Last Update Posted Date

Jan 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Soo Kim, MD, PhD, Professor, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Name	Class
Yeungnam University Hospital	OTHER
Daegu Catholic University Medical Center	OTHER
DongGuk University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigate the incidence and natural course of inflammatory bowel disease in the southeastern area of Korea.

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

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
inflammatory bowel disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All newly diagnosed cases	In one year, all inflammatory bowel disease including Crohn's disease and ulcerative colitis which is newly diagnosed in Daegu-Gyeongbuk province of Korea is recorded.	one year

Secondary Outcomes

Measure	Description	Time Frame
All operation cases	For one year, all patients who have surgical managements for IBD are counted.	one year

Other Outcomes

Measure	Description	Time Frame
All cases of disease relapse	For one year, all patients who have disease worsening are counted.	one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of inflammatory bowel disease including Crohn's disease and ulcerative colitis
Followed up for at least 6 months for the correct diagnosis

Exclusion Criteria:

Patients who do not live in Daegu-Gyeongbuk province

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with inflammatory bowel disease from primary, secondary, and tertiary hospital in Daegu-Gyeongbuk province of Korea.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eun Soo Kim, MD. PhD	Contact	+82-53-250-7088		dandy813@hanmail.net

Overall Officials

Name	Affiliation	Role
Eun Soo Kim, MD, PhD	Keimyung University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyung University Dongsan Medical Center	Recruiting	Daegu		700-712	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided