A Multicenter Prospective Study of the Feasibility and Clinical Value of a Diagnostic Service for Identifying Therapeutic Targets and Recommending Personalised Treatment for Children and Adolescents With High-risk Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
- 试验地点
- 8
- 主要终点
- Personalized medicine recommendation
研究概览
简要总结
This is a multicentre prospective study of the feasibility and clinical value of a diagnostic service for identifying therapeutic targets and recommending personalised treatment for children and adolescents with high-risk cancer.
详细描述
This is a multicentre study conducted under the Zero Childhood Cancer Program. The study will be enrolling patients under the age of 21 with high-risk cancer over 3 years from cancer centres in Australia. Patient's cancer cells will be tested for genetic abnormalities (mutations) and undergoing drug testing in highly specialised laboratories. A Multidisciplinary Tumour Board comprising of oncologists, clinical geneticists and scientists will then discuss the results of each case and determine whether a personalised medicine recommendation can be made. A report describing the results and Tumour Board recommendation (if any) will be provided to the patient's treating doctor. It is always at the discretion of the treating doctor whether to alter the patient's management based on the information arising from this research project.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Personalized medicine recommendation
时间窗: 5 years
Proportion of patients for whom personalized medicine recommendation can be made using a comprehensive diagnostic platform within a clinically relevant timeframe
次要结局
- Patients receiving the recommended personalized therapy(5 years)
- Identification of potential treatment by in vitro or in vivo drug screening(5 years)
- Tumor samples with actionable molecular alterations(5 years)
- Successfully conducted in vitro high throughput drug screening and in vivo drug sensitivity testing(5 years)
- Reporting turnaround time(5 years)
- Barriers or reasons for patients not receiving the recommended personalized therapy(5 years)
研究者
Dr David Ziegler
Professor
Sydney Children's Hospitals Network