Primary brain tumours Cancer Malignant neoplasm of brain
Conditions
Interventions
This is a phase II non-randomised observational study recruiting primary brain tumour (BT) patients and healthy volunteers. It is aimed at assessing the performance of a machine learning classifier de
along with electronic case report forms (eCRFs) and brain scan images. Data from Cohort A will be obtained via the BRIAN mobile application, eCRFs and brain scan images
whereas data from Cohort B will be obtained solely via BRIAN. BRIAN is a mobile application developed by BTC that allows individuals to anonymously record their experience living with a BT and share t
Sponsors
Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16 and above 2. Fluent English speakers 3. Willing and able to undertake study-specific measures 4. Able to provide either electronic or written consent 5. Formally diagnosed with a primary brain tumour (either based on histology or assessment of imaging at a neuro-oncology MDT) or healthy volunteers 6. Brain tumour patients with a performance status of 0, 1, or 2.
Exclusion criteria
Exclusion criteria: 1. Subjects lacking capacity to consent based on patient’s doctor’s opinion 2. Diagnosis of secondary brain tumour (i.e cancer that starts somewhere in the body and spreads to the brain) 3. Refusal to participate 4. Subjects with performance status of 3 or more 5. Subject not in possession of personal mobile device compatible with the BRIAN app
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of a machine learning model, measured as accuracy, recall, precision, and F1 score measured every 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compliance in micro-challenge use, measured as one completed entry in the BRIAN app per month per subject 2. Relationship between micro-challenge scores and participants’ clinical progression and treatment every 6 months 3. Quality of life scores from the EORTC QLQ-C30 and BN20 questionnaires every 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed