Clinical Course of Korean Crohn's Disease Cohort | NCT01554007

Studies
Clinical Course of Korean Crohn's Disease Cohort

NCT01554007

Sponsor

Kyunghee University Medical Center

Status

Unknown status

Last Update Posted

Oct 26, 2016Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Crohn's Disease

Interventions

Observation study

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

Oct 2016

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

Dec 2012

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Mar 12, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 14, 2012Estimated

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

Oct 25, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang Kyun Lee, Associate Professor, Kyunghee University Medical CenterPrincipal Investigator

Lead Sponsor

Kyunghee University Medical CenterOTHER

Collaborators

Name	Class
Asan Medical Center	OTHER
Hanyang University	OTHER
Seoul National University	OTHER
Severance Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In the past decade, the incidence and prevalence of CD (Crohn's disease) has continued to increase in Korea. Previous studies have indicated that Asian IBD (inflammatory bowel disease) patients differ from those of Western patients with regard to the genetic susceptibility and some clinical features. However, the available published data from retrospective studies in Korea were largely incomplete. The investigators aim of the study is a set-up of Korean cohort for CD, and thereby to assess the clinical course of Korean CD patients through a prospective multicenter long-term follow-up study. Secondary aims of this study are as follows: (1) to evaluate the efficacy, tolerability, and predictors to response to anti-TNF therapy for CD, (2) to identify the risk factors for postoperative recurrence on the basis of information obtained at initial diagnosis, and (3) to evaluate genotype-phenotype correlation.

Detailed Description

From 2009 to 2018, new cases of CD diagnosed will be recruited. Participants for this study will be enrolled from 33 academic teaching hospitals or colorectal specialized hospitals across Korea.

Medical records will be used to register demographic data, disease phenotype, the use of medication, flare-ups, surgery, hospitalizations, and mortality. Whole blood will be collected to central biobank with extraction of DNA ans seroum. The Montreal classification of Crohn's disease and the Crohn's disease activity index (CDAI) will be used to describe disease location, behavior and severity. F/U data will be analyzed using Kaplan-Meier analysis with log rank test and Cox regression analysis. An electronic database will be established in use of processing data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Crohn's disease		Korean patients diagnosed with Crohn's disease	Other: Observation study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation study	Other	No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.	Crohn's disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To explore natural course of Crohn's disease and to identify prognostic factors for poor disease outcome in Korean patients with Crohn's disease		10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over the age of 16
Informed consent
Patients who had a definitive diagnosis of Crohn's disease (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria)
be capable of understanding the study and replying to the questionnaires

Exclusion Criteria:

Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

About 2000 patients diagnosed with Crohn's disease in the period of January 2009 to December 2018 in multiple hospitals in Korea.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joo Sung Kim, MD, PhD	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University Guri Hospital		Guri-si			South Korea
Kyunghee University Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20560811	Background	Ye BD, Yang SK, Cho YK, Park SH, Yang DH, Yoon SM, Kim KJ, Byeon JS, Myung SJ, Yu CS, Kim JH. Clinical features and long-term prognosis of Crohn's disease in Korea. Scand J Gastroenterol. 2010 Oct;45(10):1178-85. doi: 10.3109/00365521.2010.497936.
20479907	Background	Kim ES, Kim WH. Inflammatory bowel disease in Korea: epidemiological, genomic, clinical, and therapeutic characteristics. Gut Liver. 2010 Mar;4(1):1-14. doi: 10.5009/gnl.2010.4.1.1. Epub 2010 Mar 25.

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D000068456	Clinical Studies as Topic
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods
D008919	Investigative Techniques