This trial is an observational study.
The primary outcome measure, which is used to assess the main aim of the study, is the sensitivity and specificity of post surgery increase in GAG scores (GAG recurrence) within 12 months.
Secondary outcome measures are risk of radiological recurrence, recurrence-free survival, overall survival, cancer-specific survival, GAG recurrence compared to radiological recurrence.
The trial is looking to recruit 280 people with clear cell RCC from the UK, Denmark, Finland, Italy, Norway, Portugal, and the USA.
AUR87A will be conducted in two cohorts of 140 patients. Analysis of the primary endpoint will be conducted when 30 recurrences are reported during follow-up of 12 months (cohort 1). To check the usefulness of the GAG scores are in line with study assumptions, an interim analysis will be conducted when 15 recurrences are reported. The second cohort of patients is needed to validate the findings from the first cohort.
The information collected during this study will be used to determine whether GAG scores can be used to predict or detect recurrence earlier compared to the standard test with a CT scan, and thereby improve the clinical utility of current follow-up protocols.