Clinical trial NCT06235853: Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer
Official title: Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer - an Association With Inflammatory Response and Plasminogen Activation System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-muscle Invasive Bladder Cancer
Cystoscopy
Recurrence
Progression
Bladder Cancer
Biomarkers
Keywords: Non-muscle Invasive Bladder Cancer
Cystoscopy
Recurrence
Progression
Bladder Cancer
Biomarkers
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspicion of bladder cancer

Brief 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Tumour recurrence or progression
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Wroclaw Medical University
name: Klaudia Bardowska, MD
role: PRINCIPAL_INVESTIGATOR
References: