Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2020-11-24
2027-03-01
Brief Summary
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Detailed Description
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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.
If samples are available from a patient's previous surgery to their tumour, these may also be analysed. Similarly, if available, other relevant samples such as cerebrospinal fluid, collected as part of their care, may also be analysed. In addition, as technologies and analyses improve the understanding of brain tumours, the researchers may find important results at a later date. These will be fed back to the patient's doctor. Patients will also be asked to give a blood sample, which will also be analysed to look at the molecular features, including of their DNA. This is required to identify what 'new' changes have occurred in the patient's tumour. Following surgery, patients will continue with other treatment(s) as directed by their doctor.
Treatment generally involves radiotherapy and chemotherapy. As is standard practice, patients will be closely monitored for signs of disease progression and the effects of the treatment given. As part of this study, information on patients' treatments and disease will be collected.
Images from brain scans patients undergo, along with relevant clinical information, will also be sent to and stored by the University of Edinburgh, and where appropriate, undergo expert review by a panel of radiologists with expertise in brain tumours. If patients have further surgery, some of the tissue removed may also be analysed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Matched Tumour and Blood Sample - Research Pathway
For patient's undergoing surgery fresh tissue will be collected from the initial surgery and frozen until shipment to the Oxford BRAIN MATRIX Lab. Matched blood sample for germline DNA will be taken post-Platform Study entry. For patients with progression with available tumour samples from previous tumour surgery, blood will be collected and sent to Oxford along with their tumour samples.
Samples will be shipped together to Oxford for molecular analysis (Whole Genome Sequencing (WGS) and EPIC array). The BRAIN MATRIX neuropathology and genomics team will produce an integrated report (histology, WGS, Heidelberg Classifier) for each case in consultation with the local neuropathology team. Once data is available, a virtual MDT with the BRAIN MATRIX neuropathology, genomics team and local site will be held to ensure all relevant information is incorporated in the final BRAIN MATRIX diagnostic report. The resulting integrated histological-molecular report will be available to local sites
Matched Tumour and Blood Sample - NHS GMS pathway
Tessa Jowell BRAIN MATRIX centres in England can submit matched tissue and blood samples for Whole Genome Sequencing through the standard of care NHS Genomic Medicine Service pathway via their Genomic Laboratory Hub. For those from Devolved Nations, samples must go to the Oxford BRAIN MATRIX Laboratory who can facilitate the processing of samples through an alternative NHS GMS GLH or via the research pathway.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Active treatment of other malignancy
* Contraindication to MRI
* Patients without standard of care imaging available
16 Years
ALL
No
Sponsors
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The Brain Tumour Charity
OTHER
University of Oxford
OTHER
University of Edinburgh
OTHER
Genomics England
UNKNOWN
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Colin Watts
Role: PRINCIPAL_INVESTIGATOR
Unviersity of Birmingham
Locations
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Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Queen Elizabeth Unviersity Hospital, NHS Greater Glasgow and Clyde Health Board
Glasgow, , United Kingdom
St James's University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
The Walton Centre, The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
King's College Hospital, King's College Hospital NHS Foundation Trust
London, , United Kingdom
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, , United Kingdom
The Christie Hospital, The Christie NHS Foundation Trust
Manchester, , United Kingdom
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Manchester, , United Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Victoria Wykes
Role: primary
Paul Brennan
Role: primary
Anthony Chalmers
Role: primary
Susan Short
Role: primary
Michael Jenkinson
Role: primary
Keyoumars Ashkan
Role: primary
Matthew Williams
Role: primary
Catherine McBain
Role: primary
David Coope
Role: primary
Joanne Lewis
Role: primary
Stuart Smith
Role: primary
Olaf Ansorge
Role: primary
References
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Watts C, Savage J, Patel A, Mant R, Wykes V, Pohl U, Bulbeck H, Apps J, Sharpe R, Thompson G, Waldman AD, Ansorge O, Billingham L; TJBM Investigators. Protocol for the Tessa Jowell BRAIN MATRIX Platform Study. BMJ Open. 2022 Sep 8;12(9):e067123. doi: 10.1136/bmjopen-2022-067123.
Related Links
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Other Identifiers
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14218060
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG_18-258
Identifier Type: -
Identifier Source: org_study_id