Clinical Course of Korean Crohn's Disease Cohort

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Asan Medical Center
Hanyang University
Inje University
Seoul National University
Yonsei University
Eisai Korea Inc.
Samsung Medical Center
The Catholic University of Korea
Chung-Ang University
Kyung Hee University Gangdong Hospital
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
Soonchunhyang University Hospital
Songdo hospital
Yeungnam University
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
Information provided by (Responsible Party):
Chang Kyun Lee, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01554007
First received: March 12, 2012
Last updated: January 13, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Crohn's Disease
Other: Observation study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Course of Crohn's Disease: a Prospective Multicenter Long-term Follow-up Study in Korea

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Biospecimen Retention:   Samples With DNA

Whole blood and faeces will be retained for central biobank


Estimated Enrollment: 2000
Study Start Date: December 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Crohn's disease Other: Observation study
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.

Detailed Description:

From 2009-2013, new cases of CD diagnosed will be recruited. Participants for this study will be enrolled from 30 academic teaching hospitals across Korea. Each center will enroll between 5 and 30 participants each. The cohort will be systematically followed up for 5 years after diagnosis.

Medical records will be reviewed to register demographic data, disease phenotype, the use of medication, flare-ups, surgery, hospitalizations, and mortality. Whole blood and feces will be collected to central biobank. The Montreal classification and the Crohn's disease activity index (CDAI) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

About 500 patients diagnosed with Crohn's disease in the period of January 2009 to December 2013 in academic teaching hospitals in Korea.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554007

Locations
Korea, Republic of
Hanyang University Guri Hospital
Guri, Korea, Republic of
Yonsei University; Severance Hospital
Seoul, Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of, 180-702
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Inje University
Seoul, Korea, Republic of
The Catholic University of Korea St. Vincent Hospital
Seoul, Korea, Republic of
Seoul National University SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Chung-Ang University
Seoul, Korea, Republic of
Sponsors and Collaborators
Kyunghee University Medical Center
Asan Medical Center
Hanyang University
Inje University
Seoul National University
Yonsei University
Eisai Korea Inc.
Samsung Medical Center
The Catholic University of Korea
Chung-Ang University
Kyung Hee University Gangdong Hospital
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
Soonchunhyang University Hospital
Songdo hospital
Yeungnam University
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
Investigators
Study Chair: Dong Soo Han, MD, PhD Hanyang University
  More Information

Publications:
Responsible Party: Chang Kyun Lee, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01554007     History of Changes
Other Study ID Numbers: KCDC 2011-088
Study First Received: March 12, 2012
Last Updated: January 13, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 20, 2014