Tessa Jowell BRAIN MATRIX - Platform Study
ConditionGlioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity of Birmingham
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Primary spinal cord tumours
Active treatment of other malignancy
Contraindication to MRI
Patients without standard of care imaging available
Trial population
* Patients with a newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a frozen 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Matched Tumour and Blood Sample - Research Pathway
Other interventionFor patient's undergoing surgery fresh tissue will be collected from the initial surgery and frozen until shipment to the Oxford BRAIN MATRIX Lab. Matched blood sample for germline DNA will be taken post-Platform Study entry. For patients with progression with available tumour samples from previous tumour surgery, blood will be collected and sent to Oxford along with their tumour samples. Samples will be shipped together to Oxford for molecular analysis (Whole Genome Sequencing (WGS) and EPIC array). The BRAIN MATRIX neuropathology and genomics team will produce an integrated report (histology, WGS, Heidelberg Classifier) for each case in consultation with the local neuropathology team. Once data is available, a virtual MDT with the BRAIN MATRIX neuropathology, genomics team and local site will be held to ensure all relevant information is incorporated in the final BRAIN MATRIX diagnostic report. The resulting integrated histological-molecular report will be available to local sites
Matched Tumour and Blood Sample - NHS GMS pathway
Other interventionTessa 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 pathway via their Genomic Laboratory Hub. 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Time (from biopsy) to integrated histological-molecular diagnosis using standard-of-care NHS practice
This is defined as the difference (days) between date of biopsy and date of final local pathology report.
Time frame
28 days2
Time (from biopsy) to WGS report to the treating clinician using NHS Genomic Medicine Service
This is defined at the difference (days) between date of biopsy and date that a patient's Genomic Tumour Advisory Board (GTAB) report is produced.
Time frame
28Secondary outcomes
1
Time to completion of each node of tissue and imaging pathway
The time to each node of the pathway will be measured from the date of receipt at the current node to date of delivery at the next.
Time frame
To be achieved within a timescale of up to 5 years2
Tumour and biological sample(s) quality control status
Tumour and biological sample collection will be measured against protocol guidelines. These data will be collected in the surgical and pathological forms.
Time frame
To be achieved within a timescale of up to 5 years3
Imaging quality control status
Imaging will be measured against established clinical guideline. The imaging form will measure compliance against these guidelines.
Time frame
To be achieved within a timescale of up to 5 years4
Inter-rater agreement of Response Assessment in Neuro-Oncology (RANO) assessments
Scans will be assessed and scored according to RANO criteria by the hub of Neuro-radiologists.
Time frame
To be achieved within a timescale of up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Birmingham
Lead sponsor
The Brain Tumour Charity
Collaborator
University of Oxford
Collaborator
University of Edinburgh
Collaborator
Genomics England
Collaborator
Source ClinicalTrials.gov