Clinical Course of Korean Crohn's Disease Cohort

NCT ID: NCT01554007

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Keywords

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Crohn's disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn's disease

Korean patients diagnosed with Crohn's disease

Observation study

Intervention Type OTHER

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

Interventions

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Observation study

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role collaborator

Seoul National University

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role collaborator

Konyang University Hospital

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role collaborator

Eulji General Hospital

OTHER

Sponsor Role collaborator

Eulji University

OTHER

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Soonchunhyang University Hospital

OTHER

Sponsor Role collaborator

Songdo hospital

UNKNOWN

Sponsor Role collaborator

Yeungnam University Hospital

OTHER

Sponsor Role collaborator

Wonkwang University

OTHER

Sponsor Role collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Jeju National University Hospital

OTHER

Sponsor Role collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Dongtan Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Chungbuk National University Hospital

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chang Kyun Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joo Sung Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Hanyang University Guri Hospital

Guri-si, , South Korea

Site Status

Kyunghee University Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University

Seoul, , South Korea

Site Status

Inje University

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea St. Vincent Hospital

Seoul, , South Korea

Site Status

Yonsei University; Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 20560811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20479907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19835218 (View on PubMed)

Other Identifiers

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KCDC 2011-088

Identifier Type: -

Identifier Source: org_study_id