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
|Condition or disease||Intervention/treatment|
|Glioma||Other: Matched Tumour and Blood Sample|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|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|
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
|Contact: Rhys Mant||0121 414 firstname.lastname@example.org|
|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|
|Principal Investigator:||Colin Watts||Unviersity of Birmingham|