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Crohn's DiseaseNCT01140789

GWA Study in Patients With Inflammatory Bowel Disease

An observational study of Crohn's Disease and Ulcerative Colitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Crohn's Disease, Ulcerative Colitis
How many people
3,600 participants
Where
1 siteHong Kong
Study dates
Apr 2010to Apr 2037
Phase
Observational

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Crohn's disease or ulcerative colitis patients as the case groups, Patients attend clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy as the control group.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    Siew C NG, PhD, +85235053996, siewchienng@cuhk.edu.hk

    Whitney TANG, MPhil, +85235051519, whitneytang@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Genome Wide Association (GWA) Study in Chinese Patients With Inflammatory Bowel Disease

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.

Read the 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.

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 groups in NCT01140789
Study groupRoleWhat they receive
Crohn's disease patientsDiagnosis of Crohn's disease by endoscopy, radiology and histology
Ulcerative colitis patientsDiagnosis of ulcerative colitis defined by endoscopy, radiology and histology
Non-IBD patientsEthically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify genetic variation among three study groups

    Data will be collected from follow up questionnaires

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2037 (estimated)
  4. Study completionApr 2037 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
3,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01140789
Sponsor's protocol ID
IBD GWA
Status last verified
Feb 2023
First submitted
8 Jun 2010
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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