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

Clinical Course of Korean Crohn's Disease Cohort

Sponsors

Lead sponsor: Kyunghee University Medical Center

Collaborator: 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

Source Kyunghee University Medical Center
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.

Overall Status Unknown status
Start Date December 2012
Completion Date December 2019
Primary Completion Date December 2018
Study Type Observational
Primary Outcome
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
Enrollment 2000
Condition
Intervention

Intervention type: Other

Intervention name: Observation study

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

Arm group label: Crohn's disease

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 16 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Joo Sung Kim, MD, PhD Study Chair Seoul National University Hospital
Location
facility
Hanyang University Guri Hospital | Guri, Korea, Republic of
Kyunghee University Medical Center | Seoul, 180-702, Korea, Republic of
Asan Medical Center | Seoul, Korea, Republic of
Chung-Ang University | Seoul, Korea, Republic of
Inje University | 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, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

October 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Kyunghee University Medical Center

Investigator full name: Chang Kyun Lee

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Crohn's disease

Description: Korean patients diagnosed with Crohn's disease

Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov