Precision Medicine for Every Child With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 11
- 主要终点
- Utility of recommended personalized therapy for HR childhood cancer patients.
研究概览
简要总结
To improve outcomes for childhood cancer patients through the implementation of precision medicine.
详细描述
Through the pilot TARGET and national PRISM trials the feasibility and benefits of using comprehensive molecular profiling and preclinical drug testing in real time for high-risk (HR) patients has been demonstrated. However, the role of precision medicine, especially in facilitating diagnosis and risk stratification in non-HR childhood cancers has not been studied. Integrative tumor-germline whole genome sequencing (WGS) analysis has the potential to advance our understanding of cancer predisposition. In this study, the ZERO platform will be extended to all children with cancer in Australia and New Zealand, evaluating the benefits of precision medicine in different childhood cancer types and risk groups.
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
- 0 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.
- •Life expectancy >6 weeks at time of enrolment
- •Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent/guardian of participant aged <18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.
排除标准
- 未提供
结局指标
主要结局
Utility of recommended personalized therapy for HR childhood cancer patients.
时间窗: 5 years
Disease control rate (stable disease + partial response + complete response) in HR patients who have received recommended personalized therapy which are molecularly and/or preclinically directed
Utility of recommended personalized therapy for non-HR childhood cancer patients.
时间窗: 5 years
The proportion of non-HR patients for whom the disease specific, clinically relevant, virtual molecular panel provides additional or equivalent results for diagnosis and risk stratification when compared with routine diagnostic tests.
次要结局
- Utility of comprehensive precision medicine for patients with rare tumors in childhood.(5 years)
- Clinical utility of germline WGS in patients with childhood cancers.(5 years)
- Utility of pre-defined virtual molecular panel for non-HR childhood cancer patients.(5 years)
- Utility of preclinical testing in HR childhood cancer patients.(5 years)
- Utility of Molecular Tumour Board (MTB) recommendation tier system for HR childhood cancer patients.(5 years)
- Treatment outcome in HR childhood cancer patients who have received recommended personalised therapy which are molecularly and/or preclinically directed.(5 years)