Chinese Patients With Inflammatory Bowel Disease
Verified October 2015 by Chinese University of Hong Kong
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong
First received: June 8, 2010
Last updated: October 5, 2015
Last verified: October 2015
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Genome Wide Association (GWA) Study in Chinese Patients With Inflammatory Bowel Disease
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
- To identify genetic variation among three study groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Up to 50ml of blood sample will be collected and stored at -80°C.
Some blood samples will be transported to Wuhan University for DNA extraction and genetic analysis. Some will be used for targeted gene capture, NGS and validation in Hong Kong. Some will be sent to Germany for transethnic response mapping. Some will be transported to the UK and DNA will be extracted and genetic analysis will be performed in the UK.
Stool samples will be collected and stored at -80°C. Some will be analysed with PCR for norovirus and faecal calprotectin in Hong Kong. Some will be sent to Germany for transethnic response mapping.Others will be stored for future analysis.
- 5 biopsies from sigmoid will be collected, snap frozen and stored at -80°C, 1 routine biopsy will also be collected for histology. Some will be sent to Germany for analysis.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
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
Ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140789
|Prince of Wales Hospital
|Shatin, Hong Kong |
|Contact: Siew C NG, PhD +85226373509 firstname.lastname@example.org |
|Contact: Kim W AU, MSc +85226322640 email@example.com |
|Sub-Investigator: Joseph J SUNG, MD |
|Sub-Investigator: Dorothy K CHOW |
|Sub-Investigator: Francis K CHAN, MD |
|Sub-Investigator: Justin C WU, MD |
Chinese University of Hong Kong
||Siew C NG, PhD
||Chinese University of Hong Kong
||Siew Chien NG, Assistant Professor, Chinese University of Hong Kong
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 8, 2010
||October 5, 2015
||Hong Kong: Department of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 26, 2016
Inflammatory Bowel Diseases
Digestive System Diseases