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

January 29, 2024 updated by: Wroclaw Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Wrocław, Poland, 50-367
        • Wroclaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with suspicion of bladder cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients after TURBT with NMIBC
Patients who underwent successful TURBT with histopathological proof of non-muscle invasive bladder cancer. Blood and urine specimen have been gathered prior to hospital admission during visit in out-patient clinic.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour recurrence or progression
Time Frame: Up to 1 year
Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Investigators

  • Principal Investigator: Klaudia Bardowska, MD, Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0073/DIA/2019/48_KB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data will be published in open access repository after publication of study results.

IPD Sharing Time Frame

Unlimited

IPD Sharing Access Criteria

Unlimited

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrence

Clinical Trials on Blood serum: sUPAR, PAI-1, IL-8.

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