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Clinical Course of Korean Crohn's Disease Cohort

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ClinicalTrials.gov Identifier: NCT01554007
Recruitment Status : Enrolling by invitation
First Posted : March 14, 2012
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Chang Kyun Lee, 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.

Condition or disease Intervention/treatment
Crohn's Disease Other: Observation study

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.


Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Course of Crohn's Disease: a Prospective Multicenter Long-term Follow-up Study in Korea
Study Start Date : December 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Group/Cohort Intervention/treatment
Crohn's disease
Korean patients diagnosed with 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.



Primary Outcome Measures :
  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 [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, DNA, and serum will be retained for central biobank


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554007


Locations
Korea, Republic of
Hanyang University Guri Hospital
Guri, Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of, 180-702
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
Sponsors and Collaborators
Kyunghee University Medical Center
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
Investigators
Study Chair: Joo Sung Kim, MD, PhD Seoul National University Hospital

Publications:
Responsible Party: Chang Kyun Lee, Associate Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01554007     History of Changes
Other Study ID Numbers: KCDC 2011-088
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Kyun Lee, Kyunghee University Medical Center:
Crohn's disease

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