Chinese Patients With Inflammatory Bowel Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01140789|
Recruitment Status : Recruiting
First Posted : June 10, 2010
Last Update Posted : April 25, 2017
|Condition or disease|
|Crohn's Disease Ulcerative Colitis|
|Study Type :||Observational|
|Estimated Enrollment :||3600 participants|
|Official Title:||Genome Wide Association (GWA) Study in Chinese Patients With Inflammatory Bowel Disease|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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.
- To identify genetic variation among three study groups [ Time Frame: 2 years ]Data will be collected from follow up questionnaires
Biospecimen Retention: Samples With DNA
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140789
|Contact: Siew C NG, PhD||+852 3505 email@example.com|
|Contact: Kim W AU, MSc||+852 3505 firstname.lastname@example.org|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Siew C NG, PhD +85226373509 email@example.com|
|Contact: Kim W AU, MSc +85226322640 firstname.lastname@example.org|
|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|