Tessa Jowell BRAIN MATRIX - Platform Study

Last updated: December 9, 2024
Sponsor: University of Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurofibromatosis

Cancer/tumors

Cancer

Treatment

Matched Tumour and Blood Sample - Research Pathway

Matched Tumour and Blood Sample - NHS GMS pathway

Clinical Study ID

NCT04274283
RG_18-258
14218060
  • Ages > 16
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) ANDsuitable for a diagnostic or therapeutic surgical procedure resulting in a tumoursample matched to a blood sample.

  • Patients with progression with known WHO Grade 2-4 glioma (those with availablefrozen tumour will be prioritised for detailed genomic analysis).

  • Valid written informed consent for the study.

Exclusion

Exclusion Criteria:

  • Primary spinal cord tumours

  • Active treatment of other malignancy

  • Contraindication to MRI

  • Patients without standard of care imaging available

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Matched Tumour and Blood Sample - Research Pathway
Phase:
Study Start date:
November 24, 2020
Estimated Completion Date:
March 01, 2027

Study 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.

Connect with a study center

  • Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

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

    Cambridge, CB2 0QQ
    United Kingdom

    Terminated

  • NHS Lothian

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Unviersity Hospital, NHS Greater Glasgow and Clyde Health Board

    Glasgow, G51 4TF
    United Kingdom

    Active - Recruiting

  • St James' University Hospital, Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • St James's University Hospital, Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • The Walton Centre, The Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ
    United Kingdom

    Active - Recruiting

  • Walton Centre, Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ
    United Kingdom

    Active - Recruiting

  • Charing Cross Hospital, Imperial College Healthcare NHS Trust

    London, W6 8RF
    United Kingdom

    Active - Recruiting

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

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Kings College Hospital, Kings College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Manchester, M6 8HD
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital, Salford Royal NHS Foundation Trust

    Manchester, M6 8HD
    United Kingdom

    Active - Recruiting

  • The Christie Hospital, The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

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

    Newcastle Upon Tyne, j.savage.1@bham.ac.uk
    United Kingdom

    Active - Recruiting

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

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

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

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • Queens Medical Centre, Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

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