Cancer patients who are referred for an early-phase clinical trial. Cancer Cancer, early-phase clinical trial
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years or over 2. Patients referred for an early-phase clinical trial with histologically confirmed advanced solid tumours 3. Patient meets one of the following criteria: 3.1. Willing and fit to have a tumour biopsy aimed at obtaining sufficient tissue for molecular profiling 3.2. Not willing/fit to have a tumour biopsy and had prior tumour molecular profiling 4. Patient deemed a suitable candidate for further systemic anti-cancer therapy 5. Willing and able to provide signed informed consent
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish a mechanism and framework in which tumour samples can be obtained and molecular profiles generated in a clinically useful timeframe (<6 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients experiencing an adverse event due to tumour biopsy as measured by Common Terminology Criteria for Adverse Events (CTCAE) and calculated at 5 years 2. Proportion of patients where biopsy contained adequate tumour measured by histological observation and calculated at 5 years 3. Proportion of patients where adequate DNA was isolated using DNA isolation assay and calculated at 5 years 4. Proportion of patients where an actionable biopsy was identified by genomic analysis and calculated at 5 years 5. Proportion of patients where appropriate therapy was accessible as assessed at molecular tumour board and calculated at 5 years | — |
Countries
Scotland, United Kingdom