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GliomaBRAIN MATRIXNCT04274283

Tessa Jowell BRAIN MATRIX - Platform Study

An observational study of Glioma, run by University of Birmingham at 14 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Glioma
What is being tested?
Matched Tumour and Blood Sample - Research Pathway and Matched Tumour and Blood Sample - NHS GMS pathway
How many people
1,000 participants
Where
14 sitesUnited Kingdom
Study dates
24 Nov 2020to Feb 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: * Patients with a newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a frozen 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).

Who may be able to join

  • 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.

Who cannot join

  • Primary spinal cord tumours
  • Active treatment of other malignancy
  • Contraindication to MRI
  • Patients without standard of care imaging available

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

14 sites in 1 country

United Kingdom14 sites, 11 recruiting
  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

    Victoria Wykes

    Recruiting
  • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

    Terminated
  • Velindre Cancer Centre, Velindre University NHS Trust

    Cardiff, CF14 2TL

    Jillian Maclean

    Recruiting
  • NHS Lothian

    Edinburgh, EH4 2XU

    Active, not recruiting
  • Queen Elizabeth Unviersity Hospital, NHS Greater Glasgow and Clyde Health Board

    Glasgow, G51 4TF

    Active, not recruiting
  • St James's University Hospital, Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

    Ryan Mathew

    Recruiting
  • The Walton Centre, The Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ

    Michael Jenkinson

    Recruiting
  • King's College Hospital, King's College Hospital NHS Foundation Trust

    London, SE5 9RS

    Keyoumars Ashkan

    Recruiting
  • Charing Cross Hospital, Imperial College Healthcare NHS Trust

    London, W6 8RF

    Matthew Williams

    Recruiting
  • The Christie Hospital, The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Catherine McBain

    Recruiting
  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Manchester, M6 8HD

    David Coope

    Recruiting
  • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

    Joanne Lewis

    Recruiting
  • Queen's Medical Centre, Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

    Stuart Smith

    Recruiting
  • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

    Meera Nandhabalan

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the detailed description

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.

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
Glioma
Being tested
Matched Tumour and Blood Sample - Research Pathway, Matched Tumour and Blood Sample - NHS GMS pathway
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Matched Tumour and Blood Sample - Research PathwayOther

    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 pathwayOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time (from biopsy) to integrated histological-molecular diagnosis using standard-of-care NHS practice

    This is defined as the difference (days) between date of biopsy and date of final local pathology report.

    Measured: 28 days

  2. Time (from biopsy) to WGS report to the treating clinician using NHS Genomic Medicine Service

    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.

    Measured: 28

Secondary outcomes (15)
  1. Time to completion of each node of tissue and imaging pathway

    The time to each node of the pathway will be measured from the date of receipt at the current node to date of delivery at the next.

    Measured: To be achieved within a timescale of up to 5 years

  2. Tumour and biological sample(s) quality control status

    Tumour and biological sample collection will be measured against protocol guidelines. These data will be collected in the surgical and pathological forms.

    Measured: To be achieved within a timescale of up to 5 years

  3. Imaging quality control status

    Imaging will be measured against established clinical guideline. The imaging form will measure compliance against these guidelines.

    Measured: To be achieved within a timescale of up to 5 years

  4. Inter-rater agreement of Response Assessment in Neuro-Oncology (RANO) assessments

    Scans will be assessed and scored according to RANO criteria by the hub of Neuro-radiologists.

    Measured: To be achieved within a timescale of up to 5 years

  5. Extent of surgical resection

    Evaluated from the post-operative MRI scan and categorised as follows: Closed biopsy, open biopsy, debulking <50%, subtotal resection 50-90%, near total resection 90-<100%, gross total resection 100%.

    Measured: To be achieved within a timescale of up to 5 years

  6. Overall survival time

    Defined as the time from date of diagnosis to the date of death. Patients who are alive at the time of analysis will be censored at the date last seen in clinic.

    Measured: To be achieved within a timescale of up to 5 years

  7. Intracranial progression-free survival time

    Defined as the time from date of registration to the earliest of date of intracranial progressive disease or death from disease. The date of an event is defined as the earliest confirmation of progression by radiological assessment, clinical symptoms or MDT. Patients without progression at the time of analysis will be censored at the date last seen in clinic.

    Measured: To be achieved within a timescale of up to 5 years

  8. Quality of Life (QoL) scores

    Longitudinal measures of QoL will be generated from the QoL questionnaire according to the questionnaire-specific algorithm for scoring.

    Measured: To be achieved within a timescale of up to 5 years

  9. Type of interventions received

    Details of the type of interventions received will be monitored throughout the follow-up period and recorded on the Case Report Form.

    Measured: To be achieved within a timescale of up to 5 years

  10. Type of complications from treatments (standard of care) received.

    Details of complications relating to standard of care treatments received will be monitored throughout the follow-up period and recorded on the Case Report Form.

    Measured: To be achieved within a timescale of up to 5 years

  11. Concordance of diagnoses

    In relation to initial local radiological diagnosis, local pathological diagnosis and integrated histological-molecular diagnosis, any difference between the tiers of diagnoses will be highlighted and categorised as: discordant; agreed; refined.

    Measured: To be achieved within a timescale of up to 5 years

  12. Samples and images centrally stored

    Defined as confirmed central storage of images and material.

    Measured: To be achieved within a timescale of up to 5 years

  13. Targetable mutation(s) identified

    Relevant targetable mutations identified by Whole Genome Sequencing and Epigenomic Classification.

    Measured: To be achieved within a timescale of up to 5 years

  14. Post-mortem sampling consent status and sample collection confirmation

    Based on receipt of post-mortem consent form, and on post-mortem samples with confirmed central storage.

    Measured: To be achieved within a timescale of up to 5 years

  15. Number of applications to, and outputs resulting from data repository

    As per title.

    Measured: To be achieved within a timescale of up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start24 Nov 2020
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274283
Sponsor's protocol ID
RG_18-258
Other IDs
14218060
Acronym
BRAIN MATRIX
Status last verified
Apr 2026
First submitted
14 Feb 2020
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Scientifically sound proposals from appropriately qualified researchers will be considered for data sharing. Requests should be made by returning a Data Sharing Request Form to newbusiness@trials.bham.ac.uk; this captures the research requirements, statistical analysis plan, and intended publication schedule. Requests will be reviewed by the Cancer Research UK Clinical Trials Unit (CRCTU) Directors in discussion with the Chief Investigator (CI), Study Management Group (SMG) and independent Scientific Advisory Board (SAB). They will consider the scientific validity of the request, qualifications of the researchers, CI, SMG \& SAB views, consent arrangements, practicality of anonymizing the requested data \& contractual obligations. If supportive of the request, and where not already obtained, Sponsor consent for data transfer will be sought before notifying applicants of the outcome. It is anticipated that applicants will be notified within 3 months of receipt of the original request.

Publications

  • 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.

    PubMed 36378622

Questions about this trial

What is this clinical trial studying?

An observational study of Glioma, run by University of Birmingham at 14 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rhys Mant (0121 414 6788, brainmatrix@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time (from biopsy) to integrated histological-molecular diagnosis using standard-of-care NHS practice (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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