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.
As the first clinical study in the AURORAX series, Elypta is proud to sponsor the largest study ever in ccRCC biomarkers.
AURORAX-0087A (AUR87A) is a prospective multi-center observational in vitro diagnostics clinical validation cohort study to validate the diagnostic performance of free GAGome-based tests for the early detection of recurrence after curative intent surgery in patients with high or intermediate risk ccRCC.
AURORAX-0087A is registered at ClinicalTrials.gov (NCT04006405).