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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06235853
• Other study ID #: 0073/DIA/2019/48_KB
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Bladder Cancer
• Cystoscopy
• Disease Progression
• Non-muscle Invasive Bladder Cancer
• Progression
• Recurrence
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Blood serum: sUPAR, PAI-1, IL-8.
The concentration of described biomarkers were measured in serum.
• Urine: IL-8, APOE, VEGF.
The concentration of described biomarkers were measured in urine.

Locations

Country	Name	City	State
Poland	Wroclaw Medical University	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour recurrence or progression	Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy.	Up to 1 year