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Canadian Children Inflammatory Bowel Disease Network (CIDsCANN) (CIDsCaNN)

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ClinicalTrials.gov Identifier: NCT02308917
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : June 24, 2019
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
British Columbia Children's Hospital
Alberta Children's Hospital
Stollery Children's Hospital
IWK Health Centre
Montreal Children's Hospital of the MUHC
St. Justine's Hospital
Health Sciences Centre, Winnipeg, Manitoba
Eastern Health
Children's Hospital of Western Ontario
McMaster Children's Hospital
Information provided by (Responsible Party):
Anne Griffiths, The Hospital for Sick Children

Brief Summary:
The initial network clinical study will be an inception cohort study in children with new onset IBD (Inflammatory Bowel Disease) rigorously phenotyped and prospectively followed. 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. Anticipated variation between network sites in choices of evidence-based therapies, even among phenotypically similar sub-types of Crohn disease and ulcerative colitis, will allow comparisons outcomes with disparate treatments, aiming to identify best practice and to institute processes for continual improvement in care nationally.

Condition or disease
Inflammatory Bowel Diseases Crohn Ulcerative Colitis

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Canadian Children Inflammatory Bowel Disease Network (CIDsCANN): A Joint Partnership of CIHR and C.H.I.L.D. Foundation: Multi-center Inception Cohort Study
Study Start Date : September 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Sustained Clinical Remission [ Time Frame: 18 months after enrollment onto study ]
    Primary outcome: To identify sustained clinical remission which is defined for Crohn's Disease by PCDAI (Pediatric Crohn's Disease Activity Index) <10 and for Ulcerative Colitis as PUCAI (Pediatric Ulcerative Colitis Activity Index) < 10 at each of the 6, 12, and 18 month visits AND including physician global assessment of interval disease severity as quiescent at each of these visits. This primary endpoint will be assessed at 18 months after study enrollment to determine if sustained clinical remission is maintained.


Secondary Outcome Measures :
  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) [ Time Frame: 18 months after initial enrollment onto study ]
    Initial treatment response will be assessed at 30 days using a combination of PCDAI (Pediatric Crohn's Disease Activity Index), PUCAI (Pediatric Ulcerative Colitis Activity Index), physician global assessment of disease activity, serologic inflammatory markers and fecal calprotectin results where applicable. Information from ongoing studies shows that 60% of patients are in a sustained clinical remission by 12 months. These results will identify the percentage of patients at achieve initial treatment response within 30 days.


Other Outcome Measures:
  1. Assessment of Intestinal Healing [ Time Frame: 18 months after initial enrollment onto study ]
    Assessment of intestinal healing will be captured at Network Sites. Sites will be asked annually to record whether or not reassessment via endoscopy and/or MR imaging have/ has been performed and, if so, to record findings using the multi-item measures as at time of diagnosis. After 4 years of study initiation, the results will be analysed to ascertain whether including assessment using endoscopy and/or MR imaging is more accurate than assessing clinical symptoms and signs alone.


Biospecimen Retention:   Samples With DNA
Blood samples Urine Samples Biopsy Samples Colonoscopy Washing Samples Stool Samples


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Ages Eligible for Study:   24 Months to 198 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The network will enroll all children and adolescents newly diagnosed with IBD - Crohn's, Ulcerative Colitis or inflammatory bowel disease undefined (Paris A1a or A1b definitions of age at diagnosis) at participating sites.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to give informed consent

Information from the National Library of Medicine

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): NCT02308917


Contacts
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Contact: Anne M Griffiths, MD, FRCPC (416) 813-8757 anne.griffiths@sickkids.ca

Locations
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Canada, Alberta
Alberta Children'S Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Jennifer De Bruyne, MD    403-955-3071    Jennifer.debruyn@albertahealthservices.ca   
Principal Investigator: Jennifer De Bruyn, MD         
Stollery Children'S Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Hien Huynh, MD    780-248-5420    hien.huynh@ualberta.ca   
Principal Investigator: Hien Huynh, MD         
Canada, British Columbia
Children'S Hospital of Bc Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Kevan Jacobson, MD    604-875-2332 ext 1    kjacobson@cw.bc.ca   
Principal Investigator: Kevan Jacobson, MD         
Canada, Manitoba
Winnipeg Children'S Hospital Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Wael El-Matary, MD    204-787-1039    welmatary@exchange.hsc.mb.ca   
Principal Investigator: Wael El-Matary, MD         
Canada, Newfoundland and Labrador
Janeway Children'S Health & Rehabilitation Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Jeffrey Critch, MD    709-777-4134    jeff.critch@easternhealth.ca   
Principal Investigator: Jeffrey Critch, MD         
Canada, Nova Scotia
Izaak Walton Killam Hospital (Iwk) Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Anthony Otley, MD    902-470-8784 ext 8225    arotley@iwk.nshealth.ca   
Principal Investigator: Anthony Otley, MD         
Canada, Ontario
William Osler Health System Active, not recruiting
Brampton, Ontario, Canada, L6R3J7
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L8E7
Contact: Mary Sherlock    905-521-2100    sherlom@mcmaster.ca   
CHILDRENS HOSPITAL OF WESTERN ONTARIO, Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6C2R5
Contact: Kevin Bax    519-685-8354    kevin.bax@lhsc.on.ca   
Children's Hospital of Eastern Ontario (CHEO) Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: David Mack, MD    613-737-7600 ext 2516    dmack@cheo.on.ca   
Principal Investigator: David Mack, MD         
SickKids Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Peter Church, MD    416-813-7733    peter.church@sickkids.ca   
Contact: Thomas Walters, MD    416-813-5143    thomas.walters@sickkids.ca   
Principal Investigator: Peter Church, MD         
Canada, Quebec
Montreal Children'S Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Ernest Seidman, MD    514-934-1934 ext 44385    ernest.seidman@mcgill.ca   
Principal Investigator: Ernest Seidman, MD         
Hopital Ste. Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Colette Deslandres, MD    514-346-4931 ext 6203    Colette_deslandres@ssss.gouv.qc.ca   
Principal Investigator: Colette Deslandres, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
British Columbia Children's Hospital
Alberta Children's Hospital
Stollery Children's Hospital
IWK Health Centre
Montreal Children's Hospital of the MUHC
St. Justine's Hospital
Health Sciences Centre, Winnipeg, Manitoba
Eastern Health
Children's Hospital of Western Ontario
McMaster Children's Hospital
Investigators
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Principal Investigator: Anne M Griffiths, MD, FRCPC The Hospital for Sick Children

Additional Information:

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Responsible Party: Anne Griffiths, Division Head, Gastroenterology, Hepathology and Nutrition, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02308917     History of Changes
Other Study ID Numbers: 1000039604
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Keywords provided by Anne Griffiths, The Hospital for Sick Children:
IBD
Crohn's
Ulcerative
Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes