New methods of follow up on urinary bladder cancer
| ISRCTN | ISRCTN17419456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17419456 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PIG6/24 |
| Sponsor | University Hospital Brno |
| Funders | University Hospital Brno, Masarykova Univerzita |
- Submission date
- 02/07/2025
- Registration date
- 11/08/2025
- Last edited
- 11/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
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
Public, Scientific, Principal investigator
University Hospital Brno, Jihlavská 20
Brno
62500
Czech Republic
| Phone | +420602613746 |
|---|---|
| moravcikova.maria@fnbrno.cz |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional controlled trial |
| Secondary study design | Non randomised study |
| Study type | 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(s) |
Malign and benign lesions during re-endoresection of urinary bladder tumor will be measured using laser confocal endomicroscopy at one time point |
| Key secondary outcome measure(s) |
Confirmation between benign and malignant lesions will be undertaken after the examination by laser confocal endomicroscopy, using histopathological examination at one time point |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 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
Brno
62500
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/07/2025: Study's existence confirmed by the Multicentric Ethics Committee, Faculty Hospital Brno.
