Crohn's Disease Clinical Trial
Official title:
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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