NCT06235853

Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer

Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer - an Association With Inflammatory Response and Plasminogen Activation System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Bladder cancer (BC) is one of the most common type of cancer globally. Due to its high incidence rate, high risk of recurrence and progression, and frequent cystoscopy surveillance, BC contributes to major healthcare costs across the world. The goal of this prospective study was to evaluate the prognostic value of novel non-muscle invasive bladder cancer (NMIBC) biomarkers for predicting disease recurrence or progression after radical transurethral resection of bladder tumour (TURBT). The data obtained from this study may help physicians identify patients who are at greater risk of NMIBC recurrence or progression and require close supervision.

Detailed description

The aim of our prospective study was to determine the prognostic impact of the inflammatory response and indicators of nutritional status on recurrence and progression of non-muscle invasive bladder cancer (NMIBC) in patients undergoing transurethral resection of bladder tumour (TURBT). We evaluated six biomarkers, 3 in blood serum: soluble urokinase plasminogen activator receptor (sUPAR), plasminogen activator inhibitor-1 (PAI-1), interleukin 8 (IL-8) and 3 in urine: apolipoprotein E (APOE), vascular endothelial growth factor (VEGF), interleukin 8 (IL-8). Furthermore, following indicators of nutritional status were investigated: Glasgow Prognostic Score (GPS) and Modified Glasgow Prognostic Score (mGPS). The primary endpoint of this study was the recurrence or progression of NMIBC based on the histopathological or cystoscopic result. The study outcome was evaluated during the first surveillance cystoscopy, which was performed in time intervals indicated by European Association of Urology. Based on literature data and statistical assumptions we aimed to recruit 240 patients with NMIBC.

Conditions

• Non-muscle Invasive Bladder Cancer
• Cystoscopy
• Recurrence
• Progression
• Bladder Cancer
• Biomarkers

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood serum: sUPAR, PAI-1, IL-8.	The concentration of described biomarkers were measured in serum.
DIAGNOSTIC_TEST	Urine: IL-8, APOE, VEGF.	The concentration of described biomarkers were measured in urine.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2023-04-30
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: Poland