Clinical Course of Korean Crohn's Disease Cohort
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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 |
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 |
About 500 patients diagnosed with Crohn's disease in the period of January 2009 to December 2013 in academic teaching hospitals in Korea.
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| 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 | |
| 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 May 16, 2013