NCT02308917

Brief Summary

The CIDsCaNN Network is being established with the major goals of identifying why IBD develops so commonly in children and adolescents living in Canada, and of determining the best treatment strategies for different types of IBD. Focusing on a prospective, inception cohort of Canadian children of widely varied racial origins provides a unique opportunity to explore environmental risk factors early in life and close in time to disease onset, their influence on the host microbiome, and in the context of genetic susceptibility. In keeping with current treatment targets, assessed outcomes will include not only symptom resolution and growth, but also intestinal healing. We aim to identify best practice and to institute processes for continual improvement in care nationally.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

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 Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

12.6 years

First QC Date

October 29, 2013

Last Update Submit

March 18, 2024

Conditions

Keywords

IBD-UCrohn'sUlcerative colitisIBD

Outcome Measures

Primary Outcomes (1)

  • Sustained Clinical Remission

    Primary outcome: To test the research hypothesis, the primary endpoint is sustained clinical remission, as defined for CD by PCDAI \<10 and for UC as PUCAI \< 10 at each of the 6, 12, and 18 month visits AND physician global assessment of interval disease severity as quiescent at each of these visits. This primary endpoint will be assessed at 18 months, although it is the intent of the network to continue evaluations of the cohort until transfer to adult care.

    18 months after enrollment onto study

Secondary Outcomes (1)

  • Other Clinical Outcomes (combination of Pediatric Crohn's Disease Activity Index, Pediatric Ulcerative Colitis Activity Index, physician global assessment of disease activity, serologic inflammatory markers and fecal calprotectin results)

    18 months after initial enrollment onto study

Other Outcomes (1)

  • Assessment of Intestinal Healing

    18 months after initial enrollment onto study

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The network will enroll all children and adolescents diagnosed with IBD - Crohn's, Ulcerative Colitis or inflammatory bowel disease undefined (Paris A1a or A1b definitions of age at diagnosis) at participating sites.

You may qualify if:

  • diagnosed with IBD - Crohn's, ulcerative colitis or inflammatory bowel disease undefined

You may not qualify if:

  • Refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Alberta Children'S Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Stollery Children'S Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Children'S Hospital of Bc

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Winnipeg Children'S Hospital

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

Janeway Children'S Health & Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

Izaak Walton Killam Hospital (Iwk)

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, L8L8E7, Canada

RECRUITING

CHILDRENS HOSPITAL OF WESTERN ONTARIO, Lawson Health Research Institute

London, Ontario, N6C2R5, Canada

RECRUITING

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

SickKids Hospital

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Montreal Children'S Hospital

Montreal, Quebec, H3H 1P3, Canada

RECRUITING

Hopital Ste. Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Stool samples Biopsy Samples Colonoscopy Washing Samples Colonoscopy Brushing Samples Resection Tissue Urine Samples

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Anne M Griffiths, MD, FRCPC

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne M Griffiths, MD, FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
144 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Gastroenterology, Hepathology and Nutrition

Study Record Dates

First Submitted

October 29, 2013

First Posted

December 5, 2014

Study Start

September 1, 2013

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations