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Tessa Jowell BRAIN MATRIX - Platform Study (BRAIN MATRIX)

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ClinicalTrials.gov Identifier: NCT04274283
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : July 15, 2021
Sponsor:
Collaborators:
The Brain Tumour Charity
University of Oxford
University of Edinburgh
Information provided by (Responsible Party):
University of Birmingham

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.

Condition or disease Intervention/treatment
Glioma Other: Matched Tumour and Blood Sample

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Matched Tumour and Blood Sample

    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.



Primary Outcome Measures :
  1. Time (from biopsy) to integrated histological - molecular diagnosis [ Time Frame: 28 days ]
    This is defined as the difference (days) between dates of biopsy and whole genome diagnosis and epigenomic classification


Secondary Outcome Measures :
  1. Time to completion of each node of tissue and imaging pathway [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Measured from the date of receipt at the current node to delivery at the next

  2. Tumour and biological sample(s) quality control status [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Tumour and biological sample collection will be measured against protocol guidelines. This data will be collected in the surgical and pathological forms.

  3. Imaging quality control status [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Imaging will be measured against established clinical guideline. The imaging form will measure compliance against these guidelines.

  4. Inter-rater agreement of Response Assessment in Neuro-Oncology (RANO) [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Scans will be assessed and scored according to RANO criteria by the hub of Neuro-radiologists.

  5. Extent of surgical resection [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Calculated as follows: Volume removed = initial volume before surgery - residual volume after surgery (based on imaging obtained within 72 hours of surgery).

  6. Overall survival time [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Defined as the time from date of diagnosis to the date of death. Surviving patients will be censored at the date last seen in clinic.

  7. Intracranial Progression Free Survival Time [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Defined as the time from date of registration to the earliest of date of Intracranial progressive disease or death from disease. The date of an event is defined as the earliest confirmation of progression by radiological assessment, clinical symptoms or MDT. Patients without progression will be censored at the date last seen in clinic.

  8. Quality if Life (QoL) scores [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Longitudinal QoL data will be scored according to the questionnaire-specific algorithm.

  9. Type of interventions received [ Time Frame: To be achieved within a timescale of up to 5 years ]
    This will be monitored throughout the follow-up period and recorded on the Case Report Form.

  10. Type of complications from treatments (standard of care) received. [ Time Frame: To be achieved within a timescale of up to 5 years ]
    This will be monitored throughout the follow-up period and recorded on the Case Report Form.

  11. Concordance between initial local radiological diagnosis, local pathological diagnosis, and integrated histological-molecular diagnosis. [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Any difference between the tiers of diagnoses will be highlighted and categorised as: discordant; agreed; refined.

  12. Samples and images centrally stored [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Defined as confirmed central storage of images and material.

  13. Targetable mutation(s) identified by Whole Genome Sequencing and Epigenomic Classification [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Relevant targetable mutations identified by Whole Genome Sequencing and Epigenomic Classification.

  14. Post-mortem sampling consent status and sample collection confirmation [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Based on receipt of post-mortem consent form, and on post-mortem samples with confirmed central storage.

  15. Number of applications to, and outputs resulting from data repository [ Time Frame: To be achieved within a timescale of up to 5 years ]
    Number of applications to, and outputs resulting from data repository, including trial proposals both within and outside of the Tessa Jowell BRAIN MATRIX network.


Biospecimen Retention:   Samples With DNA
  • Fresh Frozen Tissue
  • Germline DNA
  • Liquid Biopsies


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274283


Contacts
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Contact: Rhys Mant 0121 414 6788 brainmatrix@trials.bham.ac.uk

Locations
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United Kingdom
Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NhS Foundation Trust Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Victoria Wykes         
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Principal Investigator: Gary Doherty         
NHS Lothian Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Principal Investigator: Paul Brennan         
Queen Elizabeth Unviersity Hospital, NHS Greater Glasgow and Clyde Health Board Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Principal Investigator: Anthony Chalmers         
St James' University Hospital, Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Susan Short         
Walton Centre, Walton Centre NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L9 7LJ
Principal Investigator: Michael Jenkinson         
Kings College Hospital, Kings College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Keyoumars Ashkan         
The Christie Hospital, The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Catherine McBain         
Salford Royal Hospital, Salford Royal NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M6 8HD
Principal Investigator: David Coope         
Queens Medical Centre, Nottingham University Hospitals NHS Trust Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Principal Investigator: Stuart Smith         
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Principal Investigator: Meera Nandhabalan         
Sponsors and Collaborators
University of Birmingham
The Brain Tumour Charity
University of Oxford
University of Edinburgh
Investigators
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Principal Investigator: Colin Watts Unviersity of Birmingham
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04274283    
Other Study ID Numbers: RG_18-258
14218060 ( Registry Identifier: ISRCTN )
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue