Tessa Jowell BRAIN MATRIX - Platform Study

Not Applicable

• Conditions: Glioma; Cancer; Malignant neoplasm of brain

• Registration Number: ISRCTN14218060
• Lead Sponsor: niversity of Birmingham

Brief Summary

2022 Protocol article in http://dx.doi.org/10.1136/bmjopen-2022-067123 (added 27/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-03
• Last Update Posted: 15 January 2024
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1000

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

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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

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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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 30/06/2022:<br> Time (from biopsy) to integrated histological–molecular diagnosis (TTMD), defined as the difference (days) between dates of biopsy and date of whole genome diagnosis and epigenomic classification, measured within 28 days.<br><br> Previous primary outcome measure:<br> Time (from biopsy) to integrated histological – molecular diagnosis (TTMD), defined as the difference (days) between dates of biopsy and whole genome diagnosis and epigenomic classification, measured within 28 days.<br>