- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01140789
GWA Study in Patients With Inflammatory Bowel Disease
February 7, 2023 updated by: Siew Chien NG, Chinese University of Hong Kong
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
3600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Siew C NG, PhD
- Phone Number: +852 3505 3509
- Email: siewchienng@cuhk.edu.hk
Study Contact Backup
- Name: Kim W AU, MSc
- Phone Number: +852 3505 2640
- Email: kimau@surgery.cuhk.edu.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- Prince of Wales Hospital
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Contact:
- Siew C NG, PhD
- Phone Number: +85235053996
- Email: siewchienng@cuhk.edu.hk
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Contact:
- Whitney TANG, MPhil
- Phone Number: +85235051519
- Email: whitneytang@cuhk.edu.hk
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Sub-Investigator:
- Francis K CHAN, MD
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Sub-Investigator:
- Justin C WU, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify genetic variation among three study groups
Time Frame: 2 years
|
Data will be collected from follow up questionnaires
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2010
Primary Completion (ANTICIPATED)
April 1, 2037
Study Completion (ANTICIPATED)
April 1, 2037
Study Registration Dates
First Submitted
June 8, 2010
First Submitted That Met QC Criteria
June 9, 2010
First Posted (ESTIMATE)
June 10, 2010
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBD GWA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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