GWA Study in Patients With Inflammatory Bowel Disease

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT01140789
Collaborator
(none)
3,600
1
324
11.1

Study Details

Study Description

Brief Summary

The aim of this study is to identify new genes in Chinese patients that help investigators to understand the biological pathway and functions in a population in whom the incidence of Inflammatory Bowel Disease (IBD) is increasing. And to explore the genetic variations in Chinese patients with IBD.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory disorders of the gut that cause major life-long disability. Afflicting mostly young people at an age when they are most active both in their private and professional life, inflammatory bowel disease (IBD) represents an important public health problem affecting both the patients education, working abilities, social life . In the past two decades, the incidence and prevalence of CD and UC have been rapidly increasing in Asia. Familial aggregation, twin studies, and recent genetic studies suggest that there is an important genetic component to IBD. In the West, genome wide association (GWA) studies have identified more than 50 genes associated with CD including genes involved in bacterial handling, NOD 2, and the genes involved in autophagy ATG16L1 and IRGM. Only a few of these genes have been studied in Asian populations. Of those which have been studied, such as NOD2, there have been clear differences from Western populations. To date most of the GWA studies have been carried out in cohorts of Caucasian patients. Genetic studies in ethnically different populations may identify new causal variants in IBD, which are likely to lead to further insights into pathophysiology and potential treatments. The aim is to perform a GWA study in Chinese patients with CD and UC. Identifying new genes in Chinese patients will help the investigators to understand the biological pathway and functions in a population in whom the incidence of IBD is increasing. As part of a collaborative project with China, we aim to collect blood samples from 1600 IBD patients and 2000 control subjects in Hong Kong to conduct a GWA study. Samples of 300 IBD patients and 500 controls will be contributed to a collaborative project with China.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3600 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Genome Wide Association (GWA) Study in Chinese Patients With Inflammatory Bowel Disease
    Actual Study Start Date :
    Apr 1, 2010
    Anticipated Primary Completion Date :
    Apr 1, 2037
    Anticipated Study Completion Date :
    Apr 1, 2037

    Arms and Interventions

    Arm Intervention/Treatment
    Crohn's disease patients

    Diagnosis of Crohn's disease by endoscopy, radiology and histology

    Ulcerative colitis patients

    Diagnosis of ulcerative colitis defined by endoscopy, radiology and histology

    Non-IBD patients

    Ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy.

    Outcome Measures

    Primary Outcome Measures

    1. To identify genetic variation among three study groups [2 years]

      Data will be collected from follow up questionnaires

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18 or above

    • Informed consent given by patient or family

    Case group (IBD patients) Diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology

    Control group (non-IBD cases) Ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy.

    Exclusion Criteria:
    • No consent

    • Controls will be excluded if they have previously been diagnosed with IBD or if they have a first or second degree relative with IBD.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Siew C NG, PhD, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Siew Chien NG, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT01140789
    Other Study ID Numbers:
    • IBD GWA
    First Posted:
    Jun 10, 2010
    Last Update Posted:
    Apr 29, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2020