ISRCTN21731605进行中（未招募）未知
Stratified medicine paediatrics: genomic characterisation of relapsed paediatric cancers for diagnostics and stratified therapy
Institute of Cancer Research, London0 个研究点目标入组 550 人开始时间: 2019年1月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 15/03/2023:
- •1. Patients with a relapsed or refractory paediatric tumour (all solid tumours, central nervous system (CNS) tumours and lymphoma) or leukaemia
- •2. For solid tumours: Formalin fixed paraffin embedded (FFPE) tumour available from a biopsy, resection or other surgical procedure that was taken within 8 weeks of trial entry*
- •3. For leukaemia: Viable fresh or frozen Bone Marrow aspirate sample taken at a prior assessment within 8 weeks prior to trial entry**
- •3. Written informed consent of patient/parent/guardian/legal guardian***
- •* To allow full multi-omic analysis both fresh frozen and Formalin fixed paraffin embedded (FFPE) tumour plus a blood sample for constitutional (germline) and circulating tumour (ct) DNA will need to be available.
- •Original diagnostic slides should be submitted at the same time as block from current relapse/refractory episode either in same shipment.
- •** Where available, a cerebrospinal fluid (CSF) sample in the event of an isolated or combined CNS relapse should also be provided in addition to the bone marrow aspirate.
- •*** Some adult patients with brain tumours or brain metastases may be incapable of providing their own consent due to the neurological effects of their disease. In such cases, these patients will be classed as an incapacitated adult and a consultee will be sought.
- •Previous inclusion criteria:
- •1. Patients with a relapsed or refractory paediatric tumour (all solid tumours, central nervous system (CNS) tumours and lymphoma)
- •2. Formalin fixed paraffin embedded (FFPE) tumour available from a biopsy, resection or other surgical procedure that was taken within 8 weeks of trial entry*
- •3. Written informed consent of patient/parent/guardian/legal guardian**
- •* To allow full multi-omic analysis both fresh frozen and Formalin fixed paraffin embedded (FFPE) tumour plus a blood sample for constitutional (germline) and circulating tumour (ct) DNA will need to be available.
- •Original diagnostic slides should be submitted at the same time as block from current relapse/refractory episode either in same shipment or via PathXL (see laboratory manual for further details).
- •** Some adult patients with brain tumours or brain metastases may be incapable of providing their own consent due to the neurological effects of their disease. In such cases, these patients will be classed as an incapacitated adult and a consultee will be sought.
排除标准
- •Does not meet inclusion criteria
研究者
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