Non-metastatic clear cell renal cell carcinoma (ccRCC) can be curatively treated by partial or radical nephrectomy. However, about ~20% of ccRCC patients experience recurrence within 5 years after surgery. There are currently no validated liquid biomarkers for ccRCC. Therefore, current follow-up protocols for the surveillance of ccRCC recurrence are sub-optimal being schematic and at best based on prognostic risk scores. On the other hand, early detection of recurrence could open the possibility of new curative options for ccRCC patients with recurrence.
AURORAX-0087A (AUR87A) was a prospective, multicentre observational in vitro diagnostic clinical performance study evaluating urine glycosaminoglycan (GAG) based testing for the detection of recurrence following curative-intent surgery in patients with intermediate- or high-risk ccRCC.
Cohort 1 was used for test development. Cohort 2 was an independent clinical validation cohort in which the locked test configuration was evaluated against radiologically confirmed recurrence. The test configuration evaluated in Cohort 2 did not meet the prespecified criteria for clinical validation for this intended use. Plasma was not analysed for this endpoint. Full results: AUR87A Cohort 2 results
The locked Cohort 2 configuration was based on three chondroitin sulfate disaccharides as analytical inputs, whereas earlier GAG test configurations used a broader 17-analyte panel.
AURORAX-0087A is registered at ClinicalTrials.gov (NCT04006405).
Page updated 27 August 2026.
