Chinese Patients With Inflammatory Bowel Disease
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Crohn's Disease Ulcerative Colitis Healthy Participants |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Genome Wide Association (GWA) Study in Chinese Patients With Inflammatory Bowel Disease |
- To identify genetic variation among three study groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Up to 20ml of blood sample will be collected in EDTA tube from IBD patients or controls and stored at -80 degree celcius. Blood samples will be transported to Wuhan University for DNA extraction and genetic analysis
| Estimated Enrollment: | 3600 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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
|
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Non-IBD patients
Ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy.
|
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 300 IBD patients and 500 controls to conduct a GWA study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
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| Contact: Siew C NG, PhD | +85226373509 | siewchienng@cuhk.edu.hk |
| Contact: Kim W AU, MSc | +85226322640 | kimau@surgery.cuhk.edu.hk |
| Hong Kong | |
| Prince of Wales Hospital | Recruiting |
| Shatin, Hong Kong | |
| Contact: Siew C NG, PhD +85226373509 siewchienng@cuhk.edu.hk | |
| Contact: Kim W AU, MSc +85226322640 kimau@surgery.cuhk.edu.hk | |
| Sub-Investigator: Joseph J SUNG, MD | |
| Sub-Investigator: Dorothy K CHOW | |
| Sub-Investigator: Francis K CHAN, MD | |
| Sub-Investigator: Justin C WU, MD | |
| Principal Investigator: | Siew C NG, PhD | Chinese University of Hong Kong |
More Information
No publications provided
| Responsible Party: | Siew Chien NG, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01140789 History of Changes |
| Other Study ID Numbers: | IBD GWA |
| Study First Received: | June 8, 2010 |
| Last Updated: | June 9, 2010 |
| Health Authority: | Hong Kong: Department of Health |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013