Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02308917 |
| Other study ID # |
1000039604 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2013 |
| Est. completion date |
April 1, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
The Hospital for Sick Children |
| Contact |
Anne M Griffiths, MD, FRCPC |
| Phone |
(416) 813-8757 |
| Email |
anne.griffiths[@]sickkids.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
IBD is also known as Crohn's Disease or Ulcerative Colitis. Please read the definitions of
each of these conditions below:
1. Crohn's Disease: A condition that causes "inflammation" which is swelling, redness,
soreness, in different parts of your intestines; either the large intestine only, the
small intestine only or both.
2. Ulcerative Colitis: A condition that causes "inflammation" which is swelling, redness
and soreness in the lining of your large intestine (colon) only.
IBD may run in families, meaning that it can be passed down through genes. However, compared
to other parts of the world, it has been found that the number of children with IBD living in
Canada is higher. It has also been found that children whose families have come from parts of
the world where IBD is not common, have the same chance of developing IBD as children born
and raised in Canada. This seems particularly true for children, whose families have come
here from South Asia. Because of this, doctors think that aside from genetic factors, there
may be factors in the environment to explain why this has been observed.
At this time, the factors in the environment which can trigger the development of IBD are not
well understood. By working together in the Network, physicians who treat IBD will be able to
gain a better understanding of the environmental factors that contribute to the development
of IBD.
We aim to enroll children and teenagers who have developed IBD and are being treated at
participating Network centers in Canada with the goal of sharing biological samples,
demographic and lifestyle information, disease history, and treatment outcomes.
Samples may be stored indefinitely so that, as additional genes, biomarkers, and microbes are
discovered, their role in intestinal disease can be assessed. The importance of these samples
increase over time as outcomes of intestinal disease and treatment may be tracked. As
required in future, research studies proposing to use biobank data and/or samples will be
submitted to a study committee and the REB (Research Ethics Board) for approval.
Approximately 2400 participants will be recruited to the Networks Inception Cohort study.
They will be followed from recruitment until transfer to adult care.
The National Coordinating Centre Team and Organizational Structure
The Network's National Coordinating Centre is housed at The Hospital for Sick Children,
University of Toronto. Information Technology infrastructure and support will be provided by
the SickKids Research Institute's Research IT Department. Additional 'ad-hoc' resources
related to IT development/support, legal counsel, bio-statistical assistance will be
available to the centre as required via the resources of the SickKids Research Institute.
The National Coordinating Centre is responsible for data-integrity and completeness and
ensures accountability by sites for full and timely data completeness. Support systems for
collecting and recording data and encourages 'real-time' data abstraction and direct data
entry. The Network is utilizing the REDCap (Research Electronic Data Capture) application as
its primary data-collection platform. REDCap is a secure, web-based application designed to
support data capture for research studies, providing: 1) an intuitive interface for validated
data entry; 2) audit trails for tracking data manipulation and export procedures; 3)
automated export procedures for seamless data download to common statistical packages; and 4)
procedures for importing data from external sources. Within the data collection platform,
numerous 'real-time' and 'post hoc' data check procedures will be implemented. Statistics
concerning 'data-integrity' will be reported to the Executive Committee on a regular and
frequent basis. The National Coordinating Centre will conduct site-specific staff training at
the initiation of the study, when new staff are employed, and when any new tools or
significant study procedures are added to the protocol.
ORGANIZATION and GOVERNANCE of NETWORK
Preamble: During the next 5-year period, the Network Executive will aim to provide both the
opportunity and governance to foster development of new leaders in pediatric IBD in Canada;
continue to lead in pediatric IBD research; and initiate a plan for sustainability in
leadership and research productivity/funding. Diversity in the broadest sense, inclusiveness
and engagement will be core values for performance. Taken together, the proposed Network
governance has been changed in the following ways:
1. A plan for regular renewal of the 3-person Executive committee, which going forward will
always consist of 2 co-chairs and a co-chair elect.
2. A Steering Committee (composed of committee leads or co-leads and with two additional
early career representatives) will be formed in which each committee will be responsible
for specific academic areas and will develop a process for renewal of its leadership.
The Steering Committee will meet on a monthly basis and report to the Executive
committee to update progress in their areas of responsibility and the two bodies
together will drive Network activities and plans.
3. A more comprehensive, broader-ranging committee structure with clear responsibilities
and deliverables.
1) 3-person Executive committee The 3-person executive committee is responsible for the
overall directions, operation, and decisions of the Network. In a Network that aims to be
sustainable, it is mandatory that there be a mechanism for renewal and revitalization of such
leadership.
For the sake of continuity, heading into phase 2, the previous Chair (Griffiths) and one
Co-chair (Mack) of the former Network Management Committee (NMC) will remain on the Executive
Committee as Co-chairs. A nomination committee, consisting of Drs. David Mack, Anthony Otley,
and Sally Lawrence, geographically representing respectively Central, Eastern and Western
Canada, will establish a slate of candidates for the Co-chair elect position to be voted on
by the Network membership in the context of the late fall annual meeting. Process for voting
to be established at late August steering committee meeting.
In general, as the Network continues in the future, an elected incoming Co-chair elect, will
serve on the Executive committee for 3 years (one year as co-chair Elect; two years as
Co-chair), long enough to allow success in leadership, but short enough so that the
opportunity for such leadership is open to the many qualified individuals within the Network,
which will enrich the reach and impact of the Network efforts. As a new Chair-elect joins the
3-person executive committee, the longest serving Co-chair moves off, having in general
served for 3 years.
The first co-chair Elect will join Drs Griffiths and Mack on the Executive committee in the
late fall of 2021. Given the crucial period of the upcoming two years, this Executive
committee will exceptionally remain in place until fall of 2023 (rather than 2022, as would
happen in general). The delayed movement of Dr. Griffiths off the Executive committee and
correspondingly delayed second election of a new member will mean that the 2021 co-chair
elect will exceptionally serve in leadership for 4 years instead of the customary three
years.
2) Steering committee Members of the Steering Committee are either committee Leads or (for
larger committees) Co-Leads, with the exception that two positions are reserved for early
career representatives (one representing Basic Research; one representing Clinical and
Translational research). These are all named in Figure. The early career representatives,
chosen based on their abilities, accomplishments and contributions to the Network to date,
are affiliated with committees, but are not being given administrative responsibilities for
committee leadership. It is anticipated that they will contribute meaningfully to Steering
committee discussions in these roles, which have been developed as part of the Network's
commitment to Training and Mentoring of the next generation of leaders.
At monthly joint meetings of the Steering and Executive committees, the expectations are 1)
that committee leads will report on their activities and 2) all members together will discuss
and make decisions about Network initiatives.
This change in governance structure is being made for four main reasons: 1) to allow more
regular and more productive interactions between leaders with clinical investigative
expertise and those with basic research expertise, given the phase 2 mandate to ensure
optimal utilization of collected biospecimens, 2) to allow delegation of responsibilities
with accountability, thereby aiming to increase transparency and productivity 3) to allow for
greater engagement of Canadian pediatric IBD sub-specialists to find solutions for pediatric
IBD, to further standardize care and 4) to foster development of new and emerging leaders.
3) Broader committee structure As shown in the Figure, the scope of committee involvement has
increased from the time of Network initiation to now include Clinical care and research;
Education; Patient engagement and advocacy; Training and Mentorship in addition to the prior
(but somewhat renamed and refocused) Basic and Translational Research; Data management and
integration; Health services research. Committees with larger portfolios will have co-leads,
with shared responsibilities.
Basic and Translational research committee (BTRC): Co-Leads: Bruce Vallance and Eytan Wine
Clinical care and research committee (CCRC): Co-leads, Hien Huynh and Wael El-Matary Data
Management and Integration: Lead,: Thomas Walters Health Services Research: Lead, Eric
Benchimol Training and Mentorship: Lead, Kevan Jacobson Education: Co-leads, Colette
Deslandres and Sally Lawrence Patient engagement and advocacy: Lead, Anthony Otley
The Network remains primarily a Network for research aimed at enhancing clinical outcomes, be
it development of disease prevention strategies or superior treatment paradigms. It is
committed to encouraging individuals to drive specific questions using the infrastructure
provided and drawing on a larger patient base than is available in individual centres. A
robust data management platform with feedback of data to sites will support collection and
utilization of biospecimens for basic research. Consent for linkage of data/samples to
administrative health data will facilitate long-term follow-up.
An important improvement in Governance structure is the planned crosstalk between committees
(e.g., ensuring mutual input between BTRC and CCRC projects), which will be achieved through
the steering committee meetings as well as via co-membership in lead committees.
The addition of network-wide virtual educational initiatives over the past year has
demonstrated that this is an effective way of engaging more physicians, researchers, and
allied healthcare professionals in the Network. We anticipate that such interactive
educational sessions will in turn 1) encourage greater engagement in prospective research and
2) provide a forum wherein data generated within the Network's studies will be shared,
thereby stimulating further research and benefiting the clinical care of other patients
nationally.
We anticipate that the Patient engagement and advocacy committee will have similar impact
within the network.
