Tessa Jowell BRAIN MATRIX
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 Tessa Jowell BRAIN MATRIX)
- Lead researcher: Professor Colin Watts
- Where: University of Birmingham and other centers
- When: March 2019 - February 2024
- Cost: £2,829,449 initially.
- Research type: Adult and Paediatric, Any glioma Grade 2 Grade 3 or Grade 4, Clinical Trial
The Tessa Jowell BRAIN MATRIX is a first-of-its-kind study that will enable doctors to treat brain tumours with drugs that are more targeted than ever before. We are excited to be investing £2.8 million to set the study up, and to drive it into the future.
Although the study is being led from the UK, we expect it to deliver global impact for brain cancer patients.
This study has been named the Tessa Jowell BRAIN MATRIX in honour of Baroness Tessa Jowell, who bravely shared her diagnosis of a brain tumour on her 70th birthday. Following that revelation Tessa used her influence as a former minister to work towards 'more people living longer better lives with cancer'. She was a strong advocate for adaptive clinical trials and for enabling people to share their data to improve the understanding of these terrible diseases. Both of these ideals are the core foundations that were also driving our researchers when they developed BRAIN MATRIX.
What's so special about this study?
The forward-thinking design of the Tessa Jowell BRAIN MATRIX provides a platform for trialing precision medicines in the UK. It has a multi-center “portal” protocol to recruit patients and enable enrolment into biomarker-driven trials. This study will essentially pave the way for future drug treatments to be tested faster.
All participants in Tessa Jowell BRAIN MATRIX will have their tumour tested in a lab to uncover its molecular profile. In addition to the information about molecular changes in the tumour, imaging, treatment and other clinical data from each participant will be collected and analysed at a central hub. This will allow for more powerful analysis than ever before.
By having molecular profiles ready-to-hand future trials will be a step ahead and people will know, sooner, if the new experimental treatments could be appropriate for them.
The criteria are relatively wide, meaning the 10 UK neurocentres taking part will be able to offer the study to more people than any other brain tumour trial.
Initially, it will be open to any adult who is newly diagnosed with a grade 2, 3 or 4 glioma, who is able to undergo a surgical procedure, including biopsy. It will also include adults with recurrent tumours if the clinical team can access an appropriate sample of their original tumour.
The team are working hard to broaden the criteria to include children in the near future.
At the moment the study is not open for recruitment. We'll make an announcement at a later date and then, if you're interested in enrolling you'll need to discuss it with your consultant. The Brain Tumour Charity is NOT able to enroll you directly onto the study.
This ground-breaking study is under the leadership of Professor Colin Watts. Colin is Professor of Neurosurgery at the Queen Elizabeth Hospital Birmingham and Chair of the University of Birmingham's Brain Cancer Program. Along with Birmingham, the initial centres that will be able to recruit people onto this study are in Edinburgh, Leeds, Kings College London, Cambridge, Glasgow, Liverpool, Manchester, Nottingham and Oxford.
All of these locations house major referral centres for people with a suspected glioma, and it means that the majority of people in Scotland and England with a brain tumour will come under their care.
At the moment the study is not open for recruitment. If you are not being treated at one of the recruitment centres and are interested in the study please discuss it with your consultant. You may still be able to be involved in the study, however you will need to be able to travel regularly to one of the centres. The Brain Tumour Charity are NOT able to enroll you directly onto the study.
In the first phase of the study, everyone who takes part will have surgery or a biopsy. The tumour that is removed will then be tested so participants, and the researchers, will know the molecular profile of their tumour. This is called molecular diagnosis.
All participants will receive the current gold standard treatment, along with added monitoring.
Tessa Jowell BRAIN MATRIX also asks a surgical question “Is the extent of tumour removal through surgery (resection) linked to the molecular diagnosis?” It has previously been reported that the average extent of resection was 73% in patients who have a mutation in a gene called IDH, but only 28% for patients with a tumour where the IDH gene remains normal. Tessa Jowell BRAIN MATRIX will look to verify that finding and also test other molecular markers to see if they find similar differences. They will then use this information to better understand the role of surgery in the treatment plan for people with brain tumours.
Everyone on the trial will also contribute their data to BRIAN, our pioneering app that allows people to track, share and compare their experiences of coping with a brain tumour.
The first official day of funding will be in early 2019, though some of the ground work has already begun. Throughout 2019 the team was working hard to get everything set up for the formal study opening, and they aim for the first person to be recruited within a year.
The set up for this study will take longer than some other studies because it is planning for the future and aiming to cover such a large recruitment area.
Every clinical study has to go through strict checks on ethics, as well as local approvals at each centre before the first person can join up.
The team have been granted ethical approval, meaning they are legally empowered to open the trial. They are now confirming that each centre has the backing of their local institutions, as well as the resources needed to deliver the trial well. This is imminent and we are expecting the first person to be enrolled on the trial in the next few weeks.
A molecular profile looks for changes (mutations) in the tumour profile compared to the non-tumour profiles (in other words, the norm). Different combinations of changes (different molecular profiles) cause different brain tumours.
It's important to understand what molecular profile a tumour has, because some drugs only work on certain profiles, and this ensures doctors can give treatments that will work best in each case.
One of the most important things that a clinical study can do for the patients of the future is to collect really good quality data from people going through the new treatments. The data will be used to find patterns in treatment-response and to form new questions that need to be researched.
All the participants of the Tessa Jowell BRAIN MATRIX study will be contributing their information to BRIAN. As this is an inbuilt part of the study, the data collected will be more complete, and therefore of the best quality possible.
A great strength of BRIAN is that it will collect data from clinical sources (i.e. doctors) but it will also enable participants to record their own observations too. In this way people will be able to share what it is really like to be living with a brain tumour, and they will be able to compare their experiences with others going through the same thing.
If you are living with a brain tumour and interested in contributing to BRIAN, you don't have to be on any studies, just follow the link below to sign up today.
What does it hope to achieve?
This study will set up a system in the UK to enable patients with a glioma to be given treatments specific to their tumour, with the goal of reducing side effects and increasing survival.
The team will have tested whether it is possible to get a molecular profile of a brain tumour fast enough to influence which treatment is offered.
The trial will also be testing the surgical question of whether it's possible to remove more tumour when it has a particular genetic traits, when compared to tumours with different molecular profiles.
At the end of this study researchers aim to have facilitated the opening of more targeted treatment trials for people with brain tumours in a shorter time than ever before.