NCT05028660

AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study

Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Elypta · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC).

Detailed description

There are around 200 000 cases of bladder cancer (BCa) in the EU every year. Of these, about 25% are diagnosed at a late stage wherein cancer has invaded the muscular wall. The survival of patients with muscle-invasive bladder cancer (MIBC) largely depends on the response to disease management, which in turn is likely dependent on the biology underlying different subtypes of MIBC. The standard treatment is radical cystectomy (RC) and eligible patients are offered neo-adjuvant chemotherapy (NAC). However, only 30% of these patients report a complete response. Even though the response to NAC is likely correlated to the underlying tumor biology (for example, the TP53-like MIBC subtype is associated with a higher frequency of resistance to NAC), there are today no approved biomarkers to select patients likely to benefit from NAC. This information could in turn translate into more precise and personalized treatment for the patient. In a proof-of-concept prospective study, we discovered that the profiling of urine and plasma glycosaminoglycans (GAGs) could be useful for the diagnosis and prognosis of BCa. AUR93A is a prospective single-arm cohort exploratory study. A sample size of approx. 47 patients with MIBC and elected for NAC will be included in this study and it is assumed that 30% will experience complete response at the post-operative visit. The goal is to correlate baseline (pre-NAC) GAGs to complete response rate (CRR) after RC and recurrence-free survival (RFS).

Conditions

• Muscle-Invasive Bladder Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	GAG score	blood and urine samples to determine GAG scores

Timeline

• Start date: 2021-07-21
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2021-08-31
• Last updated: 2025-05-09

Locations

5 sites across 3 countries: Denmark, Italy, Sweden