New methods of follow up on urinary bladder cancer

ISRCTN	ISRCTN17419456
DOI	https://doi.org/10.1186/ISRCTN17419456
Secondary identifying numbers	PIG6/24

Submission date: 02/07/2025
Registration date: 11/08/2025
Last edited: 11/08/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The study aims to improve follow-up on patients diagnosed with urinary bladder cancer using endomicroscopy.

Who can participate?
Adult patients with diagnosed urinary bladder cancer stratified as pT1, who have to undergo re-endoresection of the urinary bladder tumor.

What does the study involve?
The study involves a cystoscopy under general anesthesia - examination of the urinary bladder via urethra and intravenous application of a fluorescent agent.

What are the possible benefits and risks of participating?
The benefit of the study is to improve future follow-up of patients with pT1 bladder cancer, during a procedure that will only prolong the necessary surgery for a few minutes.

The main risk of participating is an allergic reaction to the fluorescent agent.

Where is the study run from?
The research is a part of doctoral studies at the University Hospital Brno, Czech Republic

When is the study starting and how long is it expected to run for?
April 2024 to December 2027

Who is funding the study?
The University Hospital Brno, Czech Republic

Who is the main contact?
Dr Mária Moravčíková, moravcikova.maria@fnbrno.cz

Contact information

Dr Mária Moravčíková
Public, Scientific, Principal Investigator

University Hospital Brno, Jihlavská 20
Brno
62500
Czech Republic

Phone	+420602613746
Email	moravcikova.maria@fnbrno.cz

Study information

Study design	Single-centre interventional controlled trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic, Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	New methods of follow-up on non-muscle invasive urinary bladder cancer using confocal laser endomicroscopy
Study acronym	UBCLEM
Study objectives	The study is focused on patients with non-muscle invasive urinary bladder cancer. The group of patients with histology findings pT1 are recommended to undergo a second endoresection of the bladder tumor to prevent a recurrent disease and to exclude the presence of residual tumor. During the procedure, the bladder mucosa will be examined by a confocal laser endomicroscope. This will provide a real-time microscopic imaging of the mucosa that will be used to distinguish between benign and malignant lesions. The procedure will continue with standard endoscopic repeated resection of suspicious tissue to compare the results from confocal laser endomicroscopy with histopathological results. This study aims to find out whether confocal laser endomicroscopy is precise enough compared with histopathological examination. The secondary aim is to try to prevent patients from second re-endoresection if a procedure under general anesthesia is not inevitable.
Ethics approval(s)	Approved 10/04/2024, Ethics Board of The University Hospital Brno (Jihlavská 20, Brno, 62500, Czech Republic; +420532232798; etickakomise@fnbrno.cz), ref: Reference number: 09-100424/EK, Project number: 52/24
Health condition(s) or problem(s) studied	Follow-up care and treatment of patients diagnosed with urinary bladder cancer.
Intervention	This interventional study includes patients with non-muscle invasive bladder cancer, stratified as pT1. The patients will undergo a standard second re-endoresection of the urinary bladder tumor. Before this procedure under general anesthesia, the mucosa of the bladder will be examined with laser confocal endomicroscopy. This examination will provide real-time visualisation of atypical mucosa and submucosa cells. A fluorescent agent is administered intravenously shortly before examination to aid visualisation.
Intervention type	Procedure/Surgery
Primary outcome measure	Malign and benign lesions during re-endoresection of urinary bladder tumor will be measured using laser confocal endomicroscopy at one time point
Secondary outcome measures	Confirmation between benign and malignant lesions will be undertaken after the examination by laser confocal endomicroscopy, using histopathological examination at one time point
Overall study start date	01/04/2024
Completion date	31/12/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	Patients with diagnosed urinary bladder cancer stratified as pT1, who have to undergo re-endoresection of the urinary bladder tumor.
Key exclusion criteria	First histological examination without detection of muscle tissue (pTX), incomplete first resections.
Date of first enrolment	01/09/2025
Date of final enrolment	31/12/2027

Locations

Countries of recruitment

Czech Republic

Study participating centre

University Hospital Brno

Jihlavská 20
Brno
62500
Czech Republic

Sponsor information

University Hospital Brno
Hospital/treatment centre

Jihlavská 20
Brno
62500
Czech Republic

Phone	+420532233860
Email	kralikova.iveta@fnbrno.cz
Website	https://www.fnbrno.cz/urologicka-klinika/k1490
"ROR"	https://ror.org/00qq1fp34

Funders

Funder type

University/education

University Hospital Brno

No information available

Masarykova Univerzita
Government organisation / Local government

Alternative name(s): Masaryk University, MU
Location: Czech Republic

Results and Publications

Intention to publish date	01/12/2028
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	Identifiable patient data will not be available or shared with a third party. The data-sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

04/07/2025: Study's existence confirmed by the Multicentric Ethics Committee, Faculty Hospital Brno.