Tessa Jowell BRAIN MATRIX - Platform Study

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 - Platform Study

Registry ID
ISRCTN14218060
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Birmingham
Enrollment
1000
Start date
2020-11-24
Completion date
2027-03-01
Last update
2026-08-17

Conditions

Summary

Glioma

Detailed description

Current intervention as of 30/06/2022: Research Pathway: For patient’s undergoing surgery, fresh tissue will be collected from the patient’s initial surgery and frozen until shipment to the Oxford BRAIN MATRIX Laboratory. Matched blood sample for germline DNA will be taken following entry into the Platform Study. For patients with progression and have available tumour samples from previous tumour surgery, blood will be collected and submitted to the Oxford BRAIN MATRIX Laboratory along with their tumour samples. Blood taken at Platform Entry and frozen tissue taken at first surgery will be shipped together to the Oxford BRAIN MATRIX Laboratory for molecular analysis, as follows: 1. Whole Genome Sequencing 2. EPIC array The BRAIN MATRIX neuropathology and genomics team will generate an integrated report (histology, Whole Genome Sequencing, Heidelberg Classifier) for each case in consultation with the local neuropathology team. When this data is available, the BRAIN MATRIX neuropathology and genomics team will conduct a virtual MDT with the local referring site to ensure all relevant information will be incorporated in the final BRAIN MATRIX diagnostic report. The resulting integrated histological-molecular report will be available to local sites. NHS Genomics Medicine Service Pathway: 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 (GMS) pathway via their Genomic Laboratory Hub (GLH). 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. For all patients: Pseudoanonymised MRI for each patient will be collected and stored at a central imaging hub overseen by the Edinburgh Imaging Hub. Disease response assessment will be performed and additional analysis undertaken within permitted parameters. Data

Interventions

Inclusion criteria

Current inclusion criteria as of 03/01/2024: 1. Any patient ≥16 years 2. 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 3. Patients with progression with known WHO Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis) 4. Valid written informed consent for the study _____ Previous inclusion criteria from 07/01/2021 to 03/01/2024: 1. 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 2. Patients with progression with known WHO Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis) 3. Valid written informed consent for the study _____ Original inclusion criteria: 1. Newly diagnosed suspected glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a tumour sample matched to a blood sample 2. Patients with progression with known Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis) 3. Valid written informed consent for the study

Exclusion criteria

1. Primary spinal cord tumours 2. Active treatment of other malignancy 3. Contraindication to MRI 4. Patients without standard of care imaging available (added 07/01/2021)

Locations

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