Condition category
Cancer
Date applied
30/07/2020
Date assigned
10/09/2020
Last edited
10/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Publication citations

Additional files

Editorial Notes

04/08/2020: Trial's existence confirmed by the National Ethical Committee (Etikprövningsmyndigheten).