Non-muscle Invasive Bladder CancerNCT06235853
Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer
An observational study of Non-muscle Invasive Bladder Cancer and Cystoscopy, run by Wroclaw Medical University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer, Cystoscopy, Recurrence
- What is being tested?
- Blood serum: sUPAR, PAI-1, IL-8. and Urine: IL-8, APOE, VEGF.
- How many people
- 240 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with suspicion of bladder cancer
Who may be able to join
- Signed informed consent form
- Presence or suspicion of tumour in urinary bladder
- Qualification for the first transurethral resection of bladder tumour
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-muscle Invasive Bladder Cancer, Cystoscopy, Recurrence, Progression, Bladder Cancer, Biomarkers
- Being tested
- Blood serum: sUPAR, PAI-1, IL-8., Urine: IL-8, APOE, VEGF.
- Keywords
- Non-muscle Invasive Bladder Cancer, Cystoscopy, Recurrence, Progression, Bladder Cancer, Biomarkers
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Recurrence, Disease Progression, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood serum: sUPAR, PAI-1, IL-8.Diagnostic test
The concentration of described biomarkers were measured in serum.
Urine: IL-8, APOE, VEGF.Diagnostic test
The concentration of described biomarkers were measured in urine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood serum: sUPAR, PAI-1, IL-8.; Diagnostic Test: Urine: IL-8, APOE, VEGF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour recurrence or progression
Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaudia Bardowska, MD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235853
- Sponsor's protocol ID
- 0073/DIA/2019/48_KB
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be published in open access repository after publication of study results.
Publications
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.
PubMed 39928162
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer - an Association With Inflammatory Response and Plasminogen Activation System
- ClinicalTrials.gov ID
- NCT06235853
- Acronym / sponsor ID
- 0073/DIA/2019/48_KB
- Conditions
- Non-muscle Invasive Bladder Cancer, Cystoscopy, Recurrence, Progression, Bladder Cancer, Biomarkers
- Keywords
- Non-muscle Invasive Bladder Cancer, Cystoscopy, Recurrence, Progression, Bladder Cancer, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after TURBT with NMIBC | – | Diagnostic Test: Blood serum: sUPAR, PAI-1, IL-8., Diagnostic Test: Urine: IL-8, APOE, VEGF.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of bladder cancer
Key inclusion criteria (3 listed)
- Signed informed consent form
- Presence or suspicion of tumour in urinary bladder
- Qualification for the first transurethral resection of bladder tumour
Key exclusion criteria (12 listed)
- age < 18 years
- active urinary tract infection
- active autoimmune disease
- end-stage renal failure and renal replacement therapy
- active hepatitis A, B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood serum: sUPAR, PAI-1, IL-8.The concentration of described biomarkers were measured in serum. | Diagnostic test | Patients after TURBT with NMIBC |
| Urine: IL-8, APOE, VEGF.The concentration of described biomarkers were measured in urine. | Diagnostic test | Patients after TURBT with NMIBC |
Primary outcome
Tumour recurrence or progression
Time frame: Up to 1 year
Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 39928162Bardowska 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.
- Individual participant dataSharing planned: Yes. Anonymised data will be published in open access repository after publication of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaudia Bardowska, MD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-muscle Invasive Bladder Cancer and Cystoscopy, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour recurrence or progression (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.