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

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.

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Key information

Conditions

Non-Muscle Invasive Bladder Cancer Biomarkers Bladder Cancer Carcinoma Cystoscopy Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Progression Recurrence Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wroclaw Medical University

Wroclaw, 50-367, Poland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed informed consent form
Presence or suspicion of tumour in urinary bladder
Qualification for the first transurethral resection of bladder tumour

Exclusion criteria

age < 18 years
active urinary tract infection
active autoimmune disease
end-stage renal failure and renal replacement therapy
active hepatitis A, B or C
active HIV infection
pregnancy
factors disqualifying the patient from adjuvant treatment (intravesical immunotherapy or intravesical chemotherapy)
bladder tumour stage T2 or more, or urothelial tumour in a location other than the urinary bladder
other cancer or systemic anticancer treatment carried out up to 5 years ago
factors disqualifying the patient from surgical treatment, e.g. coagulopathies
lack of patient consent to collection of blood and urine samples and to follow-up visits

Treatment and study plan

Blood serum: sUPAR, PAI-1, IL-8.

Diagnostic Test

The concentration of described biomarkers were measured in serum.

Urine: IL-8, APOE, VEGF.

Diagnostic Test

The concentration of described biomarkers were measured in urine.

Primary outcomes

Tumour recurrence or progression

Time frame: Up to 1 year

Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Feb 1, 2024
Registry last updated: Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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