Clinical trial NCT01554007: Clinical Course of Korean Crohn's Disease Cohort
Official title: Clinical Course of Crohn's Disease: a Prospective Multicenter Long-term Follow-up Study in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Keywords: Crohn's disease
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Hanyang University
name: Seoul National University
name: Severance Hospital
name: Samsung Medical Center
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Kyung Hee University Hospital at Gangdong
name: Kangbuk Samsung Hospital
name: Konyang University Hospital
name: Korea University Anam Hospital
name: Korea University
name: Eulji General Hospital
name: Eulji University
name: SMG-SNU Boramae Medical Center
name: Pusan National University Hospital
name: Inje University
name: Soonchunhyang University Hospital
name: Songdo hospital
name: Yeungnam University Hospital
name: Wonkwang University
name: Wonju Severance Christian Hospital
name: Ewha Womans University
name: Chonnam National University Hospital
name: Jeju National University Hospital
name: Chuncheon Sacred Heart Hospital
name: Hangang Sacred Heart Hospital
name: Dongtan Sacred Heart Hospital
name: Chungbuk National University Hospital
name: The Catholic University of Korea
First posted: 2012-03-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To explore natural course of Crohn's disease and to identify prognostic factors for poor disease outcome in Korean patients with Crohn's disease
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University
city: Seoul
country: Korea, Republic of
facility: Inje University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University; Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joo Sung Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Ye BD, Yang SK, Cho YK, Park SH, Yang DH, Yoon SM, Kim KJ, Byeon JS, Myung SJ, Yu CS, Kim JH. Clinical features and long-term prognosis of Crohn's disease in Korea. Scand J Gastroenterol. 2010 Oct;45(10):1178-85. doi: 10.3109/00365521.2010.497936.
citation: Kim ES, Kim WH. Inflammatory bowel disease in Korea: epidemiological, genomic, clinical, and therapeutic characteristics. Gut Liver. 2010 Mar;4(1):1-14. doi: 10.5009/gnl.2010.4.1.1. Epub 2010 Mar 25.
citation: Ye BD, Jang BI, Jeen YT, Lee KM, Kim JS, Yang SK; IBD Study Group of the Korean Association of the Study of Intestinal Diseases. [Diagnostic guideline of Crohn's disease]. Korean J Gastroenterol. 2009 Mar;53(3):161-76. Korean.