Clinical Course of Korean Crohn's Disease Cohort

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01554007
• Other study ID #: KCDC 2011-088
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 12, 2012
• Last updated: October 25, 2016
• Start date: December 2012
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Observation study
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University	Seoul
Korea, Republic of	Inje University	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea St. Vincent Hospital	Seoul
Korea, Republic of	Yonsei University; Severance Hospital	Seoul

Sponsors (30)

Lead Sponsor

Collaborator

Kyunghee University Medical Center

Asan Medical Center, Chonnam National University Hospital, Chuncheon Sacred Heart Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Chungbuk National University Hospital, Dongtan Sacred Heart Hospital, Eulji General Hospital, Eulji University, Ewha Womans University, Hangang Sacred Heart Hospital, Hanyang University, Inje University, Jeju National University Hospital, Kangbuk Samsung Hospital, Konyang University Hospital, Korea University, Korea University Anam Hospital, Kyung Hee University Hospital at Gangdong, Pusan National University Hospital, Samsung Medical Center, Seoul National University, Severance Hospital, SMG-SNU Boramae Medical Center, Songdo hospital, Soonchunhyang University Hospital, The Catholic University of Korea, Wonju Severance Christian Hospital, Wonkwang University, Yeungnam University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No