The Canadian Children Inflammatory Bowel Disease Network (CIDsCaNN): A Partnership With the CH.I.L.D. Foundation: Multi-center Inception Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 12
- 主要终点
- Sustained Clinical Remission
研究概览
简要总结
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.
详细描述
IBD is also known as Crohn's Disease or Ulcerative Colitis. Please read the definitions of each of these conditions below:
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with IBD - Crohn's, ulcerative colitis or inflammatory bowel disease undefined
排除标准
- •Refusal to give informed consent
结局指标
主要结局
Sustained Clinical Remission
时间窗: 18 months after enrollment onto study
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.
次要结局
- 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)
研究者
Anne Griffiths
Division Head, Gastroenterology, Hepathology and Nutrition
The Hospital for Sick Children