Crohn's DiseaseNCT01140789
GWA Study in Patients With Inflammatory Bowel Disease
An observational study of Crohn's Disease and Ulcerative Colitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 3,600 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2010to Apr 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Siew C NG, PhD, +85235053996, siewchienng@cuhk.edu.hk
Whitney TANG, MPhil, +85235051519, whitneytang@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To identify genetic variation among three study groups
Data will be collected from follow up questionnaires
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2037 (estimated)
- Study completionApr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew C NG, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140789
- Sponsor's protocol ID
- IBD GWA
- Status last verified
- Feb 2023
- First submitted
- 8 Jun 2010
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome Wide Association (GWA) Study in Chinese Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01140789
- Acronym / sponsor ID
- IBD GWA
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Apr 2037 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify genetic variation among three study groups
Time frame: 2 years
Data will be collected from follow up questionnaires
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siew C NG, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siew C NG, PhD (+852 3505 3509, siewchienng@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify genetic variation among three study groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.