NCT01554007

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

6 years

First QC Date

March 12, 2012

Last Update Submit

October 25, 2016

Conditions

Crohn's Disease

Keywords

Crohn's disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Crohn's disease

Korean patients diagnosed with Crohn's disease

Other: Observation study

Interventions

Observation studyOTHER

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

Crohn's disease

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hanyang University Guri Hospital

Guri-si, South Korea

Location

Kyunghee University Medical Center

Seoul, 180-702, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University

Seoul, South Korea

Location

Inje University

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

The Catholic University of Korea St. Vincent Hospital

Seoul, South Korea

Location

Yonsei University; Severance Hospital

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 20560811BACKGROUND

  • 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.

    PMID: 20479907BACKGROUND

  • 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.

    PMID: 19835218BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, DNA, and serum will be retained for central biobank

MeSH Terms

Conditions

Crohn Disease

Interventions

Observational Studies as Topic

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Joo Sung Kim, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 14, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(9)