NCT06235853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

January 11, 2024

Last Update Submit

January 29, 2024

Conditions

Non-muscle Invasive Bladder CancerCystoscopyRecurrenceProgressionBladder CancerBiomarkers

Keywords

Non-muscle Invasive Bladder CancerCystoscopyRecurrenceProgressionBladder CancerBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Tumour recurrence or progression

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

    Up to 1 year

Study Arms (1)

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.Diagnostic Test: Urine: IL-8, APOE, VEGF.

Interventions

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

The concentration of described biomarkers were measured in serum.

Patients after TURBT with NMIBC
Urine: IL-8, APOE, VEGF.DIAGNOSTIC_TEST

The concentration of described biomarkers were measured in urine.

Patients after TURBT with NMIBC

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspicion of bladder cancer

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50-367, Poland

Location

Related Publications (1)

  • Bardowska K, Krajewski W, Kolodziej A, Koscielska-Kasprzak K, Bartoszek D, Zabinska M, Chorbinska J, Kubacki F, Krolicki T, Krajewska M, Szydelko T, Kaminska D. Evaluation of six novel biomarkers for predicting recurrence of non-muscle invasive bladder cancer after endoscopic resection- a prospective observational study. World J Urol. 2025 Feb 10;43(1):114. doi: 10.1007/s00345-025-05485-9.

    PMID: 39928162DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (10 ml) and urine (10 ml) specimen

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsRecurrenceDisease ProgressionUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Klaudia Bardowska, MD

    Wroclaw Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

February 1, 2024

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ANALYTIC CODE
Time Frame
Unlimited
Access Criteria
Unlimited

Locations

PL(1)