Clinical Course of Korean Crohn's Disease Cohort

• Conditions: Crohn's Disease
• Interventions: Other: Observation study

• Registration Number: NCT01554007
• Lead Sponsor: Kyunghee University Medical Center

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.

Study Timeline

• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Study Start: 2012-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's disease	Observation study	Korean patients diagnosed with Crohn's disease

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Hanyang University Guri Hospital; 🇰🇷 Guri, Korea, Republic of

Chung-Ang University; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yonsei University; Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Inje University; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea St. Vincent Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of