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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prognostic Biomarkers in Patients With Urothelial Carcinoma

NCT04872036

Bladder Cancer

COMPLETED

Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710

NCT02756637

Bladder Cancer

COMPLETED

Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder

NCT02745301

Bladder Cancer, Biomarkers

COMPLETED

Bladder Cancer Patient-Reported Outcomes

NCT01090388

Bladder Neoplasms

COMPLETED

Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)

NCT05825950

Non-muscle-invasive Bladder Cancer

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-muscle Invasive Bladder Cancer Cystoscopy Recurrence Progression Bladder Cancer Biomarkers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

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

Intervention Type DIAGNOSTIC_TEST

The concentration of described biomarkers were measured in serum.

Urine: IL-8, APOE, VEGF.

Intervention Type DIAGNOSTIC_TEST

The concentration of described biomarkers were measured in urine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

The concentration of described biomarkers were measured in serum.

Intervention Type DIAGNOSTIC_TEST

Urine: IL-8, APOE, VEGF.

The concentration of described biomarkers were measured in urine.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No