NCT01731665

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2012Jun 2029

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

16.5 years

First QC Date

November 18, 2012

Last Update Submit

January 11, 2021

Conditions

Crohn's DiseaseUlcerative ColitisEpidemiologyKorea

Keywords

Crohn's diseaseulcerative colitisepidemiologyKorea

Outcome Measures

Primary Outcomes (1)

  • Incidence rate and prevalence rate of IBD

    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.

    1986-2017 (up to 31 years)

Secondary Outcomes (1)

  • Clinical features of patients with IBD

    1986-2017 (up to 31 years)

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • IBD unclassified
  • Ethnic groups other than Korean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17941073BACKGROUND

  • Yang 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.

    PMID: 11059934BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Suk-Kyun Yang, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suk-Kyun Yang, M.D.

CONTACT

+82-2-3010-3901sky@amc.seoul.kr

Byong Duk Ye, M.D.

CONTACT

+82-2-3010-3181bdye@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

December 1, 2012

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)