NCT04274283

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Nov 2020Feb 2028

First Submitted

Initial submission to the registry

February 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6.2 years

First QC Date

February 14, 2020

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    28 days

  • 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.

    28

Secondary Outcomes (15)

  • Time to completion of each node of tissue and imaging pathway

    To be achieved within a timescale of up to 5 years

  • Tumour and biological sample(s) quality control status

    To be achieved within a timescale of up to 5 years

  • Imaging quality control status

    To be achieved within a timescale of up to 5 years

  • Inter-rater agreement of Response Assessment in Neuro-Oncology (RANO) assessments

    To be achieved within a timescale of up to 5 years

  • Extent of surgical resection

    To be achieved within a timescale of up to 5 years

  • +10 more secondary outcomes

Interventions

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 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.

For 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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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).

You may qualify if:

  • 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.

You may not qualify if:

  • Primary spinal cord tumours
  • Active treatment of other malignancy
  • Contraindication to MRI
  • Patients without standard of care imaging available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

RECRUITING

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

TERMINATED

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff, CF14 2TL, United Kingdom

RECRUITING

NHS Lothian

Edinburgh, EH4 2XU, United Kingdom

ACTIVE NOT RECRUITING

Queen Elizabeth Unviersity Hospital, NHS Greater Glasgow and Clyde Health Board

Glasgow, G51 4TF, United Kingdom

ACTIVE NOT RECRUITING

St James's University Hospital, Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

The Walton Centre, The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

RECRUITING

King's College Hospital, King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

RECRUITING

The Christie Hospital, The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Manchester, M6 8HD, United Kingdom

RECRUITING

Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Queen's Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

RECRUITING

Related Publications (1)

  • Watts C, Savage J, Patel A, Mant R, Wykes V, Pohl U, Bulbeck H, Apps J, Sharpe R, Thompson G, Waldman AD, Ansorge O, Billingham L; TJBM Investigators. Protocol for the Tessa Jowell BRAIN MATRIX Platform Study. BMJ Open. 2022 Sep 8;12(9):e067123. doi: 10.1136/bmjopen-2022-067123.

    PMID: 36378622BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

* Fresh Frozen Tissue * Germline DNA * Liquid Biopsies

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Colin Watts

    Unviersity of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 18, 2020

Study Start

November 24, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Scientifically sound proposals from appropriately qualified researchers will be considered for data sharing. Requests should be made by returning a Data Sharing Request Form to newbusiness@trials.bham.ac.uk; this captures the research requirements, statistical analysis plan, and intended publication schedule. Requests will be reviewed by the Cancer Research UK Clinical Trials Unit (CRCTU) Directors in discussion with the Chief Investigator (CI), Study Management Group (SMG) and independent Scientific Advisory Board (SAB). They will consider the scientific validity of the request, qualifications of the researchers, CI, SMG \& SAB views, consent arrangements, practicality of anonymizing the requested data \& contractual obligations. If supportive of the request, and where not already obtained, Sponsor consent for data transfer will be sought before notifying applicants of the outcome. It is anticipated that applicants will be notified within 3 months of receipt of the original request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be available within 1 year of study closure, if not before.
Access Criteria
See Plan Description above.

Locations