Assessing the safety and effectiveness of a biopsy instrument when sampling tumours in the urinary bladder
| ISRCTN | ISRCTN80990426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80990426 |
| Secondary identifying numbers | CIV-20-05-032908 |
- Submission date
- 30/07/2020
- Registration date
- 10/09/2020
- Last edited
- 19/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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 June 2026
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
Contact information
Scientific
Department of Urology
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46 (0)40 33 19 41 |
| fredrik.liedberg@med.lu.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available |
| Scientific title | Safety and efficacy of the EndoDrill® Uro X biopsy instrument when sampling tumours in the urinary bladder |
| Study acronym | Urodrill study |
| Study objectives | Time from radiological suspicion to start of definitive treatment for muscle-invasive bladder cancer can be decreased by using the Urodrill pathway. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2019 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 74 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Jan Waldenströms gata 7
Malmö
205 02
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology
Jan Waldenströmsgata 5
Malmö
20502
Sweden
| Phone | +46 (0)40 33 10 00 |
|---|---|
| fredrik.liedberg@med.lu.se | |
| Website | http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Editorial Notes
19/12/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 30/06/2026.
2. The overall end date was changed from 31/12/2024 to 30/06/2026.
3. The intention to publish date was changed from 31/05/2025 to 31/05/2027.
04/01/2024: The study record was confirmed as being up to date.
15/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 31/12/2024.
2. The intention to publish date was changed from 31/05/2023 to 31/05/2025.
3. The plain English summary was updated to reflect these changes.
17/03/2022: The recruitment end date has been changed from 31/12/2022 to 31/12/2024.
04/08/2020: Trial's existence confirmed by the National Ethical Committee (Etikprövningsmyndigheten).
