Protocol for the Tessa Jowell BRAIN MATRIX Platform Study

IntroductionGliomas are the most common primary tumour of the central nervous system (CNS), with an estimated annual incidence of 6.6 per 100,000 individuals in the USA and around 14 deaths per day from brain tumours in the UK. The genomic and biological landscape of brain tumours has been increasingly defined and, since 2016, the WHO classification of tumours of the CNS incorporates molecular data, along with morphology, to define tumour subtypes more accurately. The Tessa Jowell BRAIN MATRIX Platform (TJBM) study aims to create a transformative clinical research infrastructure that leverages UK NHS resources to support research that is patient centric and attractive to both academic and commercial investors.Methods and analysisThe TJBM study is a programme of work with the principal purpose to improve the knowledge of glioma and treatment for glioma patients. The programme includes a platform study and subsequent interventional clinical trials (as separate protocols). The platform study described here is the backbone data-repository of disease, treatment and outcome data from clinical, imaging and pathology data being collected in glioma patients from secondary care hospitals. The primary outcome measure of the platform is time from biopsy to integrated histological-molecular diagnosis using whole genome sequencing and epigenomic classification. Secondary outcome measures include those that are process-centred, patient-centred and framework-based. Target recruitment for the study is 1000 patients with interim analyses at 100 and 500 patients.Ethics and disseminationThe protocol was approved by West Midlands - Edgbaston Research Ethics Committee. Participants will be required to provide written informed consent. The results of this study will be disseminated through national and international presentations and peer-reviewed publications.Trial registration numberClinicalTrials.gov Identifier: NCT04274283; 18-Feb-2020ISRCTN 14218060; 03-Feb-2020Strengths and limitations of this studyO_LIThe TJBM study is a programme of work, which will improve the knowledge of glioma, and treatment for glioma patients.C_LIO_LIThis platform study is a backbone data-repository of disease, treatment and outcome data from clinical, imaging and pathology dataC_LIO_LIThe TJBM study will aim to provide rapid and accurate molecular diagnosis, a network of clinical hubs with robust protocols for the collection, processing, analysis and storage of tissue, images, and clinical and quality of life dataC_LIO_LIGliomas occur at all ages and their specific subtype is difficult to predict preoperatively, therefore, the patient population eligible for the study is broad but currently excludes < 16-year-old patientsC_LI