A British Feasibility Study of Molecular Stratification and Targeted Therapy to Optimize the Clinical Management of Patients With Glioma by Enhancing Clinical Outcomes, Reducing Avoidable Toxicity, Improving Management of Post-operative Residual & Recurrent Disease and Improving Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 14
- 主要终点
- Time (from biopsy) to integrated histological-molecular diagnosis using standard-of-care NHS practice
研究概览
简要总结
The main aim of the Tessa Jowell BRAIN MATRIX - Platform Study is to more precisely determine the exact type of tumour patients have by developing the essential infrastructure to provide rapid and accurate molecular diagnosis. A large network of clinical hubs across the United Kingdom, with expertise in managing patients with brain tumours, will be developed. Once established this infrastructure will facilitate the rapid introduction of clinical trials testing targeted therapies tailored to the genetic changes of an individual's tumour.
详细描述
Gliomas, a type of brain tumour, are the most common primary tumour of the central nervous system (CNS) and in 2016 there were 5250 deaths from brain tumours in the UK. However, brain tumours are a challenging disease to treat. The tumour's location within the brain and its tendency to grow into nearby brain tissue often make it very difficult to remove the tumour completely with surgery. There is also difficulty in delivering drugs in adequate amounts to the tumour due to the natural defences of the brain.
Brain tumours arise due to changes in the DNA and other molecules in cells of the brain. Different types of gliomas can have different changes and these can be used to determine a precise 'molecular diagnosis'. The ultimate goal for the Tessa Jowell BRAIN MATRIX is to learn how to use these molecular changes to more precisely determine what exact type of tumour patients have, and to identify, decide and test whether specific 'targeted' treatments could improve the survival and/or quality of life of patients with brain tumours.
Tessa Jowell BRAIN MATRIX is a programme of work, the principal purpose of which is to improve the knowledge of, and treatment for, glioma. The programme will include a Platform Study and subsequent interventional clinical trials. The Tessa Jowell BRAIN MATRIX Platform Study forms the backbone of this programme. In the Platform Study, the aim is to develop the infrastructure to provide rapid and accurate molecular diagnosis and the infrastructure to deliver clinical trials of new therapies in the future, thereby improving clinical outcomes in brain tumours.
The researchers aim to recruit 1,000 patients to the study. As gliomas occur at all ages and their specific subtype is hard to predict pre-operatively, the patient population eligible for the study is broad. A large network of clinical hubs across the UK, with expertise in managing patients with brain tumours, will be developed. Once established this infrastructure will facilitate the rapid introduction of clinical trials testing targeted therapies tailored to the genetic changes of an individual's tumour.
Eligible patients will either have had, or be about to have, surgery for their tumour. As part of this study, tumour removed during the operation will be analysed to look for specific molecular changes. As with normal standard care, the tumour will be analysed by a local pathologist. A small part will be sent for review by experts and advanced molecular analysis will be undertaken to get a detailed understanding of the DNA/molecular changes within the patient's tumour. These results will be fed back to the patient's treating doctor. It is intended that this will occur within 28 days; however, it may be longer while the study becomes fully operational.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a tumour sample matched to a blood sample.
- •Patients with progression with known WHO Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis).
- •Valid written informed consent for the study.
排除标准
- •Primary spinal cord tumours
- •Active treatment of other malignancy
- •Contraindication to MRI
- •Patients without standard of care imaging available
结局指标
主要结局
Time (from biopsy) to integrated histological-molecular diagnosis using standard-of-care NHS practice
时间窗: 28 days
This is defined as the difference (days) between date of biopsy and date of final local pathology report.
Time (from biopsy) to WGS report to the treating clinician using NHS Genomic Medicine Service
时间窗: 28
This is defined at the difference (days) between date of biopsy and date that a patient's Genomic Tumour Advisory Board (GTAB) report is produced.
次要结局
- Type of complications from treatments (standard of care) received.(To be achieved within a timescale of up to 5 years)
- Extent of surgical resection(To be achieved within a timescale of up to 5 years)
- Tumour and biological sample(s) quality control status(To be achieved within a timescale of up to 5 years)
- Imaging quality control status(To be achieved within a timescale of up to 5 years)
- Intracranial progression-free survival time(To be achieved within a timescale of up to 5 years)
- Overall survival time(To be achieved within a timescale of up to 5 years)
- Concordance of diagnoses(To be achieved within a timescale of up to 5 years)
- Post-mortem sampling consent status and sample collection confirmation(To be achieved within a timescale of up to 5 years)
- Time to completion of each node of tissue and imaging pathway(To be achieved within a timescale of up to 5 years)
- Type of interventions received(To be achieved within a timescale of up to 5 years)
- Samples and images centrally stored(To be achieved within a timescale of up to 5 years)
- Targetable mutation(s) identified(To be achieved within a timescale of up to 5 years)
- Number of applications to, and outputs resulting from data repository(To be achieved within a timescale of up to 5 years)
- Quality of Life (QoL) scores(To be achieved within a timescale of up to 5 years)
- Inter-rater agreement of Response Assessment in Neuro-Oncology (RANO) assessments(To be achieved within a timescale of up to 5 years)