Chinese Patients With Inflammatory Bowel Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01140789
First received: June 8, 2010
Last updated: April 29, 2014
Last verified: April 2014
  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

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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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
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.

Criteria

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
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

Contacts
Contact: Siew C NG, PhD +85226373509 siewchienng@cuhk.edu.hk
Contact: Kim W AU, MSc +85226322640 kimau@surgery.cuhk.edu.hk

Locations
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         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Siew C NG, PhD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Siew Chien NG, Assistant Professor, 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: April 29, 2014
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 August 27, 2014