Crohn's Disease
Conditions
Keywords
Crohn's disease
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.
Interventions
OTHERObservation study
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
Sponsors
Asan Medical Center
Hanyang University
Seoul National University
Severance Hospital
Samsung Medical Center
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Kyung Hee University Hospital at Gangdong
Kangbuk Samsung Hospital
Konyang University Hospital
Korea University Anam Hospital
Korea University
Eulji General Hospital
Eulji University
SMG-SNU Boramae Medical Center
Pusan National University Hospital
Inje University
Soonchunhyang University Hospital
Songdo hospital
Yeungnam University Hospital
Wonkwang University
Wonju Severance Christian Hospital
Ewha Womans University
Chonnam National University Hospital
Jeju National University Hospital
Chuncheon Sacred Heart Hospital
Hangang Sacred Heart Hospital
Dongtan Sacred Heart Hospital
Chungbuk National University Hospital
The Catholic University of Korea
Kyunghee University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | 10 years |
Countries
South Korea
Outcome results
None listed