Crohn's DiseaseNCT01554007
Clinical Course of Korean Crohn's Disease Cohort
An observational study of Crohn's Disease, run by Kyunghee University Medical Center at 9 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Observation study
- How many people
- 2,000 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Dec 2012to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: About 2000 patients diagnosed with Crohn's disease in the period of January 2009 to December 2018 in multiple hospitals in Korea.
Who may be able to join
- 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
Who cannot join
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Hanyang University Guri Hospital
Guri-si
Kyunghee University Medical Center
Seoul, 180-702
Asan Medical Center
Seoul
Chung-Ang University
Seoul
Inje University
Seoul
Samsung Medical Center
Seoul
Seoul National University SMG-SNU Boramae Medical Center
Seoul
The Catholic University of Korea St. Vincent Hospital
Seoul
Yonsei University; Severance Hospital
Seoul
About this study
Official title: Clinical Course of Crohn's Disease: a Prospective Multicenter Long-term Follow-up Study in Korea
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Observation study
- Keywords
- Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation studyOther
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | Korean patients diagnosed with Crohn's disease Receives: Other: Observation study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore natural course of Crohn's disease and to identify prognostic factors for poor disease outcome in Korean patients with Crohn's disease
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Hanyang University, Seoul National University, Severance Hospital, Samsung Medical Center, Chung-Ang University Hospital, 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
- Responsible party
- Principal investigator, Chang Kyun Lee, Kyunghee University Medical Center
- Investigators
- Joo Sung Kim, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554007
- Sponsor's protocol ID
- KCDC 2011-088
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20560811Kim 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.
PubMed 20479907Ye 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.
PubMed 19835218
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course of Crohn's Disease: a Prospective Multicenter Long-term Follow-up Study in Korea
- ClinicalTrials.gov ID
- NCT01554007
- Acronym / sponsor ID
- KCDC 2011-088
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Asan Medical Center, Hanyang University, Seoul National University, Severance Hospital, Samsung Medical Center, Chung-Ang University Hospital, 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
- Study start
- Dec 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | Other: Observation studyKorean patients diagnosed with Crohn's disease |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- About 2000 patients diagnosed with Crohn's disease in the period of January 2009 to December 2018 in multiple hospitals in Korea.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation studyNo intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy. | Other | Crohn's disease |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 20560811Ye 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.
- Background: PubMed 20479907Kim 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.
- Background: PubMed 19835218Ye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Sung Kim, MD, PhD study chair
Seoul National University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Kyunghee University Medical Center at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01554007, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.