NCT01140789

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for all trials

Timeline
130mo left

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Apr 2010Apr 2037

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
26.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2037

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

27 years

First QC Date

June 8, 2010

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • To identify genetic variation among three study groups

    Data will be collected from follow up questionnaires

    2 years

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood 1. Up to 50ml of blood sample will be collected and stored at -80°C. 2. Some blood samples will be sent overseas for DNA extraction and genetic analysis. Stool 3. 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. Biopsy 4. For some patients, biopsies from sigmoid will be collected, snap frozen and stored at -80°C, 1 routine biopsy may also be collected for histology. Some will be sent overseas for analysis.

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Siew C NG, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 10, 2010

Study Start

April 1, 2010

Primary Completion (Estimated)

April 1, 2037

Study Completion (Estimated)

April 1, 2037

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations