Clinical Course of Korean Crohn's Disease Cohort

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Observation study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease