Plain English Summary
Background and study aims
Muscle-invasive bladder cancer is cancer that has spread into the muscle wall of the bladder. Treatment is based on taking a biopsy (sample) of the tumor. Today a biopsy is retrieved by a surgical procedure called transurethral resection under anesthetic before treatment with either neoadjuvant chemotherapy (drug treatment) and cystectomy (removal of the bladder) or cystectomy only. The aim of this study is to investigate a new biopsy device (Urodrill) for diagnosing muscle-invasive bladder cancer under local anesthetic.
Who can participate?
Patients aged 18 and over with suspected muscle-invasive bladder cancer
What does the study involve?
Participants are randomly allocated to undergo either standard transurethral resection or an endoscopic biopsy under local anesthetic with the Urodrill instrument.
What are the possible benefits and risks of participating?
The benefit from participating is a chance to avoid a transurethral resection of the bladder tumor under anesthetic and instead have a local anesthetic procedure in the outpatient clinic. The risks are related to biopsying the tumor in the conventional and experimental group mainly relating to bleeding after the procedure and perforation.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
November 2019 to December 2022
Who is funding the study?
Skåne Region Health Care Fund for Development and Innovation (Sweden)
Who is the main contact?
Prof. Fredrik Liedberg
fredrik.liedberg@med.lu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Fredrik Liedberg
ORCID ID
http://orcid.org/0000-0001-8193-0370
Contact details
Department of Urology
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
+46 (0)40 33 19 41
fredrik.liedberg@med.lu.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CIV-20-05-032908
Study information
Scientific title
Safety and efficacy of the EndoDrill® Uro X biopsy instrument when sampling tumours in the urinary bladder
Acronym
Urodrill study
Study hypothesis
Time from radiological suspicion to start of definitive treatment for muscle-invasive bladder cancer can be decreased by using the Urodrill pathway.
Ethics approval
Approved 18/03/2020, National Ethical Committee (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2019-06537
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available
Condition
Bladder cancer
Intervention
Method of randomisation: closed envelopes
Conventional arm: standard transurethral resection
Experimental arm: endoscopic biopsy under local anesthesia with the Urodrill instrument
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Time from radiological suspicion of MIBC to start of definitive treatment for MIBC (neoadjuvant chemotherapy and/or cystectomy): measured using prospective registration at day for radiological report stating suspicion of MIBC to starting day of neoadjuvant chemotherapy, or cystectomy for those operated without neoadjuvant chemotherapy by prospective registration
Secondary outcome measures
1. Complications from the EndoDrill biopsy procedure assessed by a structured telephone interview 2 weeks after the procedure
2. Proportion of patients with MIBC that the EndoDrill® Uro X -instrument failed to detect, but diagnosed with ordinary TURBT, measured using pathology at [at secondary procedure with TURBT for those in the experimental arm without verification of MIBC and with MIBC verified by TURBT
3. Proportion of patients with successful molecular classification based on RNA sequencing performed in real time with 6 weeks of sampling in both arms
4. Cancer-specific survival (CSS) measured using chart review at 24 months after initiating definitive treatment for MIBC
5. Overall proportion of patients who correctly followed the protocol and were staged as MIBC in the intervention arm, measured using chart review within 3 months of inclusion
6. Cost-effectiveness based on EQ5D5L at baseline and 2 weeks
7. Quality of life measured using FACT-G questionnaire preoperatively and FACT-VCI at 12 months
8. Adverse events assessed during a phone interview by a research nurse 2 weeks after the procedures
9. Sensitivity and specificity for CT-urography and MRI respectively to accurately determine muscle-invasive bladder cancer compared to the outcome of the combined measure of biopsy and cystectomy specimen, measured using sensitivity calculations compared to pathology within 3 months of inclusion
Overall trial start date
01/11/2019
Overall trial end date
31/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Provision of written informed consent
2. ≥18 years of age
3. Patients attending participating urology departments for haematuria investigation and CT-urography suspicious of muscle-invasive bladder cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
74
Participant exclusion criteria
1. Patients unable or unwilling to undergo EndoDrill biopsy
2. Bleeding diathesis prohibiting EndoDrill biopsies
3. Ongoing immunosuppression (except corticosteroids in moderate doses, less than 10 mg prednisolone or equivalent daily)
4. Patients not suitable/fit for radical treatment for MIBC
5. Pregnancy
Recruitment start date
01/10/2020
Recruitment end date
31/12/2022
Locations
Countries of recruitment
Sweden
Trial participating centre
Skånes Universitetssjukhus
Department of Urology
Jan Waldenströms gata 7
Malmö
205 02
Sweden
Sponsor information
Organisation
Skåne University Hospital
Sponsor details
Department of Urology
Jan Waldenströmsgata 5
Malmö
20502
Sweden
+46 (0)40 33 10 00
fredrik.liedberg@med.lu.se
Sponsor type
Hospital/treatment centre
Website
http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/
Funders
Funder type
Government
Funder name
Skåne Region Health Care Fund for Development and Innovation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a scientific peer-reviewed journal. The protocol and statistical analysis plan will not be publically available. The protocol has been finalised but nothing is publically available due to protection of the biopsy device.
IPD sharing statement
The datasets generated in the present study will not be stored in a publically available repository due to the small study size and mainly descriptive data.
Intention to publish date
31/05/2023
Participant level data
Not expected to be available
Basic results (scientific)
Publication list