Crohn's DiseaseNCT01731665
Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.
An observational study of Crohn's Disease and Ulcerative Colitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul, Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Epidemiology
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study is performed in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. The population of the study area was racially and ethnically homogeneous and was relatively stable in number.
Who may be able to join
- Definite cases of CD and UC
- Patients are diagnosed with CD if they meet at least 2 of the following criteria:
- clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
- endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
- radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
- macroscopic appearance of bowel wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
Show all 12Show fewer
- pathologic findings of transmural inflammation and/or epithelioid granulomas
- Only patients who meet these criteria for at least 2 months are included.
- Patients are diagnosed with UC only if all 3 of the following criteria are present
- a typical history of diarrhea or blood and pus or both in the stool for longer than 4 weeks
- a typical sigmoidoscopic or colonoscopic picture with diffusely granular, friable, or ulcerated mucosa without rectal sparing or skip lesions or radiological signs of characteristic continuous granular or ulcerated mucosa
- characteristic histopathological signs of inflammation on biopsy
Who cannot join
- IBD unclassified
- Ethnic groups other than Korean
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Suk-Kyun Yang, M.D., +82-2-3010-3901, sky@amc.seoul.kr
Byong Duk Ye, M.D., +82-2-3010-3181, bdye@amc.seoul.kr
About this study
The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul, Korea.
Read the detailed description
Inflammatory bowel disease (IBD), which is comprised of Crohn's disease (CD) and ulcerative colitis (UC) is a chronic inflammatory disease of gut with uncertain etiopathogenesis. According to our previous study (Yang, et al. Inflamm Bowel Dis 2008; 14: 542-549), the incidence and prevalence of IBD in Korea are still low compared with those in Western countries, but are rapidly increasing. However, the long-term trends of epidemiology of CD and UC together with their characteristics and prognosis in Korea are uncertain yet. The investigators therefore aim to elucidate the incidence and prevalence of CD and UC over a 30-year period, from 1986 to 2017, in the Songpa-Kangdong district of Seoul, Korea. In addition, the investigators also aim to reveal the clinical features at the time of diagnosis of IBD, long-term evolution of disease and prognosis.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Epidemiology, Korea
- Keywords
- Crohn's disease, ulcerative colitis, epidemiology, Korea
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The Songpa-Kangdong cohort of IBD | Incident cases of IBD in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. For the prevalent cases, the inhabitants with IBD at Dec 31, 2007 in the Songpa-Kangdong district are included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate and prevalence rate of IBD
- Annual incidence rate of Crohn's disease and ulcerative colitis
- Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.
Measured: 1986-2017 (up to 31 years)
Secondary outcomes (1)
Clinical features of patients with IBD
- Clinical characteristics of patients newly diagnosed with Crohn's disease or ulcerative colitis: gender, presenting symptoms, duration between symptoms to diagnosis, and phenotypes, etc.
- Clinical course of patients newly diagnosed with Crohn's disease or ulcerative colitis: development of complications (strictures, perforations), intestinal resection rate, hospitalization rate, mortality, and pregnancies and their outcomes
- Treatment modalities of IBD and their trends: use of medication (5-ASA, corticosteroids, immunomodulators, and biologic agents, etc.)
Measured: 1986-2017 (up to 31 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Seoul National University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center, Konkuk University Medical Center, National Police Hospital, Seoul Veterans Hospital, hansol hospital, Kangdong Seoul Clinic, Jamsil Seoul Surgical Clinic, Song Do Colorectal Hospital, Yang Hospital, Daehang Hospital, Kangdong Sacred Heart Hospital
- Responsible party
- Principal investigator, Suk-Kyun Yang, Asan Medical Center
- Investigators
- Suk-Kyun Yang, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731665
- Sponsor's protocol ID
- 2012-0634
- Status last verified
- Jan 2021
- First submitted
- 18 Nov 2012
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yang SK, Yun S, Kim JH, Park JY, Kim HY, Kim YH, Chang DK, Kim JS, Song IS, Park JB, Park ER, Kim KJ, Moon G, Yang SH. Epidemiology of inflammatory bowel disease in the Songpa-Kangdong district, Seoul, Korea, 1986-2005: a KASID study. Inflamm Bowel Dis. 2008 Apr;14(4):542-9. doi: 10.1002/ibd.20310.
PubMed 17941073Yang SK, Hong WS, Min YI, Kim HY, Yoo JY, Rhee PL, Rhee JC, Chang DK, Song IS, Jung SA, Park EB, Yoo HM, Lee DK, Kim YK. Incidence and prevalence of ulcerative colitis in the Songpa-Kangdong District, Seoul, Korea, 1986-1997. J Gastroenterol Hepatol. 2000 Sep;15(9):1037-42. doi: 10.1046/j.1440-1746.2000.02252.x.
PubMed 11059934
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.
- ClinicalTrials.gov ID
- NCT01731665
- Acronym / sponsor ID
- 2012-0634
- Conditions
- Crohn's Disease, Ulcerative Colitis, Epidemiology, Korea
- Keywords
- Crohn's disease, ulcerative colitis, epidemiology, Korea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Seoul National University Hospital, Seoul National University Bundang Hospital, Samsung Medical Center, Konkuk University Medical Center, National Police Hospital, Seoul Veterans Hospital, hansol hospital, Kangdong Seoul Clinic, Jamsil Seoul Surgical Clinic, Song Do Colorectal Hospital, Yang Hospital, Daehang Hospital, Kangdong Sacred Heart Hospital
- Study start
- Dec 2012 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Nov 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.
The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul, Korea.
Detailed description
Inflammatory bowel disease (IBD), which is comprised of Crohn's disease (CD) and ulcerative colitis (UC) is a chronic inflammatory disease of gut with uncertain etiopathogenesis. According to our previous study (Yang, et al. Inflamm Bowel Dis 2008; 14: 542-549), the incidence and prevalence of IBD in Korea are still low compared with those in Western countries, but are rapidly increasing. However, the long-term trends of epidemiology of CD and UC together with their characteristics and prognosis in Korea are uncertain yet. The investigators therefore aim to elucidate the incidence and prevalence of CD and UC over a 30-year period, from 1986 to 2017, in the Songpa-Kangdong district of Seoul, Korea. In addition, the investigators also aim to reveal the clinical features at the time of diagnosis of IBD, long-term evolution of disease and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Songpa-Kangdong cohort of IBD | – | –Incident cases of IBD in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. For the prevalent cases, the inhabitants with IBD at Dec 31, 2007 in the Songpa-Kangdong district are included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study is performed in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. The population of the study area was racially and ethnically homogeneous and was relatively stable in number.
Key inclusion criteria (12 listed)
- Definite cases of CD and UC
- clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
- endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
- radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
- macroscopic appearance of bowel wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
Key exclusion criteria (2 listed)
- IBD unclassified
- Ethnic groups other than Korean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate and prevalence rate of IBD
Time frame: 1986-2017 (up to 31 years)
1. Annual incidence rate of Crohn's disease and ulcerative colitis 2. Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.
1 secondary outcome
Clinical features of patients with IBD
Time frame: 1986-2017 (up to 31 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 17941073Yang SK, Yun S, Kim JH, Park JY, Kim HY, Kim YH, Chang DK, Kim JS, Song IS, Park JB, Park ER, Kim KJ, Moon G, Yang SH. Epidemiology of inflammatory bowel disease in the Songpa-Kangdong district, Seoul, Korea, 1986-2005: a KASID study. Inflamm Bowel Dis. 2008 Apr;14(4):542-9. doi: 10.1002/ibd.20310.
- Background: PubMed 11059934Yang SK, Hong WS, Min YI, Kim HY, Yoo JY, Rhee PL, Rhee JC, Chang DK, Song IS, Jung SA, Park EB, Yoo HM, Lee DK, Kim YK. Incidence and prevalence of ulcerative colitis in the Songpa-Kangdong District, Seoul, Korea, 1986-1997. J Gastroenterol Hepatol. 2000 Sep;15(9):1037-42. doi: 10.1046/j.1440-1746.2000.02252.x.
- 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.
Suk-Kyun Yang, M.D. principal investigator
Asan Medical Center
1 site 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 and Ulcerative Colitis, run by Asan Medical Center at 1 site 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 12 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suk-Kyun Yang, M.D. (+82-2-3010-3901, sky@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate and prevalence rate of IBD (time frame: 1986-2017 (up to 31 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 NCT01731665, which also lists 2 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 13 Jan 2021.