Biomarkers, Bladder Cancer, Cystoscopy, Non-muscle Invasive Bladder Cancer, Progression, Recurrence
Conditions
Keywords
Non-muscle Invasive Bladder Cancer, Cystoscopy, Recurrence, Progression, Bladder Cancer, Biomarkers
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.
Interventions
DIAGNOSTIC_TESTBlood serum: sUPAR, PAI-1, IL-8.
The concentration of described biomarkers were measured in serum.
DIAGNOSTIC_TESTUrine: IL-8, APOE, VEGF.
The concentration of described biomarkers were measured in urine.
Sponsors
Wroclaw Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumour recurrence or progression | Up to 1 year | Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy. |
Countries
Poland
Outcome results
None listed