Clinical Course of Korean Crohn's Disease Cohort

October 25, 2016 updated by: Chang Kyun Lee, Kyunghee University Medical Center

Clinical Course of Crohn's Disease: a Prospective Multicenter Long-term Follow-up Study in Korea

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2000

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
      • Guri, Korea, Republic of
        • Hanyang University Guri Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 180-702
        • KyungHee University Medical Center
      • Seoul, Korea, Republic of
        • Chung-Ang University
      • Seoul, Korea, Republic of
        • Inje University
      • Seoul, Korea, Republic of
        • Seoul National University SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of
        • The Catholic University of Korea St. Vincent Hospital
      • Seoul, Korea, Republic of
        • Yonsei University; Severance 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crohn's disease
Korean patients diagnosed with Crohn's disease
Other: Observation study
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 10 years
10 years

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Collaborators

Hangang Sacred Heart Hospital
Samsung Medical Center
Pusan National University Hospital
Asan Medical Center
Chonnam National University Hospital
Korea University Anam Hospital
Korea University
Seoul National University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Hanyang University
SMG-SNU Boramae Medical Center
Yeungnam University Hospital
Ewha Womans University
The Catholic University of Korea
Kangbuk Samsung Hospital
Severance Hospital
Eulji General Hospital
Kyung Hee University Hospital at Gangdong
Soonchunhyang University Hospital
Jeju National University Hospital
Wonju Severance Christian Hospital
Chungbuk National University Hospital
Wonkwang University
Dongtan Sacred Heart Hospital
Chuncheon Sacred Heart Hospital
Konyang University Hospital
Eulji University
Songdo hospital

Investigators

  • Study Chair: Joo Sung Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCDC 2011-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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