Tessa Jowell BRAIN MATRIX - Platform Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04274283
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Colin Watts
Principal Investigator Affiliation Unviersity of Birmingham
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Birmingham, United Kingdom

Status

Recruiting

Address

Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS Foundation Trust

Birmingham, , B15 2TH

Cambridge, United Kingdom

Status

Active, not recruiting

Address

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, , CB2 0QQ

NHS Lothian, Edinburgh, United Kingdom

Status

Recruiting

Address

NHS Lothian

Edinburgh, , EH4 2XU

Glasgow, United Kingdom

Status

Recruiting

Address

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

Glasgow, , G51 4TF

Leeds, United Kingdom

Status

Recruiting

Address

St James' University Hospital, Leeds Teaching Hospitals NHS Trust

Leeds, , LS9 7TF

Liverpool, United Kingdom

Status

Recruiting

Address

Walton Centre, Walton Centre NHS Foundation Trust

Liverpool, , L9 7LJ

London, United Kingdom

Status

Recruiting

Address

Kings College Hospital, Kings College Hospital NHS Foundation Trust

London, , SE5 9RS

Manchester, United Kingdom

Status

Recruiting

Address

The Christie Hospital, The Christie NHS Foundation Trust

Manchester, , M20 4BX

Manchester, United Kingdom

Status

Recruiting

Address

Salford Royal Hospital, Salford Royal NHS Foundation Trust

Manchester, , M6 8HD

Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

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

Nottingham, United Kingdom

Status

Recruiting

Address

Queens Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, , NG7 2UH

Oxford, United Kingdom

Status

Not yet recruiting

Address

John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, , OX3 9DU

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