NCT03855657

Brief Summary

Inflammatory bowel disease (IBD) affects 1 in 500 to 1,000 people in the West. Previously a disease predominantly of the West, there is now a marked increase in the incidence of ulcerative colitis (UC) and Crohn's disease (CD) in Asia, with an estimated prevalence of 1 in 3,000 and 1 in 10,000 respectively\[1\]. The rapid increase of IBD in Asian raising concern of investigators. Therefore setting up a large scale biobank with comprehensive clinical data is require.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
97mo left

Started Mar 2014

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%
Mar 2014Jul 2034

Study Start

First participant enrolled

March 1, 2014

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2034

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2034

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

19.9 years

First QC Date

June 27, 2018

Last Update Submit

February 7, 2023

Conditions

Keywords

Biobank

Outcome Measures

Primary Outcomes (1)

  • Setup a large scale biobank

    Set up a large scale biobank to collect data such as comprehensive clinical data, such as patient's demographic and clinical information (e.g. age, weight, gender, family history of IBD, appendectomy history, drug usage etc.)

    20 years

Secondary Outcomes (7)

  • Intestinal microbiota of IBD patient

    20 years

  • Genetics and epigenetic markers in IBD

    20 years

  • Therapeutic drug monitoring

    20 years

  • Biomarker of IBD

    20 years

  • Pathobionts of IBD

    20 years

  • +2 more secondary outcomes

Study Arms (3)

Inflammatory Bowel Disease Patient

Patient with confirmed diagnosis of Inflammatory Bowel Disease

Healthy control

Controls (non-IBD) will comprise individuals undergoing colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms, and friends and spouses or partners of patients at Prince of Wales Hospital or Alice Ho Miu Ling Nethersole Hospital, or any individuals who are interested to participate in this study.

Healthy relatives of Inflammatory Bowel Disease patient

Relatives or household members of both patients with IBD or other diseases and controls will be recruited.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology Control will comprise individuals undergoing colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms, and friends and spouses or partners of patients at Prince of Wales Hospital or Alice Ho Miu Ling Nethersole Hospital, or any individuals who are interested to participate in this study. Relatives or household members of both patients with IBD or other diseases and controls will be recruited.

You may qualify if:

  • Patient ≥18 with a diagnosis of Crohn's disease or ulcerative colitis
  • Informed Consent obtained

You may not qualify if:

  • Known current infection with an enteric pathogen
  • Previously been diagnosed with IBD (Control)
  • Have a first of second degree relative with IBD (Control)

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, Urine, Stool, Saliva and biopsies from gastrointestinal tract

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Siew Chien Ng, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siew Chien Ng, PhD

CONTACT

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 27, 2018

First Posted

February 27, 2019

Study Start

March 1, 2014

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

July 1, 2034

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations