Plain English Summary
Background and study aims
Bladder cancer is one of the most common types of cancer worldwide. The most common type of bladder cancer is non-muscle invasive bladder cancer (NMIBC) and accounts for around 75% of all newly diagnosed cases. This is where the tumor is confined to the bladder and has not spread to other parts of the body. In patients who have had a bladder tumour removed, they are usually followed up regularly in order to make sure the cancer has not returned. This is done using a procedure called white-light imaging (WLI) cystoscopy, in which a cystoscope (a thin, lighted tube with a lens) is passed up through the urethra (the tube through which you urinate). The bladder is then filled with water or saltwater solution in order to stretch the bladder walls to identify suspicious lesions (damaged areas). This procedure has to be done regularly, which can be inconvenient and uncomfortable for patients. The Xpert® Bladder Cancer Monitor is a device which tests whether certain chemical indicators (biomarkers) are present in urine which could suggest that the cancer has come back. The aim of this study is to find out whether monitoring patients with the Xpert® Bladder Cancer Monitor is as accurate as regular cystoscopies.
Who can participate?
Adults who have a previous history of non-muscle invasive bladder cancer
What does the study involve?
Participants attend routine monitoring appointments as they would usually (every three months for the first two years after first diagnosis of bladder cancer, then every six months for the fifth year, and yearly thereafter). At these appointments, patients undergo a cystoscopy, which involves a thin, lighted tube with a lens being passed up through the urethra (the tube through which you urinate) into the bladder to, and urinary cytology, which involves testing urine for abnormal cells that could suggest the cancer has come back. Participants also provide a urine sample with is then tested in the Xpert Bladder Cancer Monitor for markers that the cancer has come back. The results of the usual tests and the new test with the Xpert Bladder Cancer Monitor are then compared to find out how accurate the Xpert Bladder Cancer Monitor is.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
Medical University Innsbruck (Austria)
When is the study starting and how long is it expected to run for?
September 2016 to December 2018
Who is funding the study?
Medical University Innsbruck (Austria)
Who is the main contact?
Dr Renate Pichler
renate.pichler@tirol-kliniken.at
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Xpert bladder cancer monitor for the surveillance of patients with a previous history of non-muscle invasive bladder cancer: a diagnostic accuracy study
Acronym
Study hypothesis
The aim of this study is to evaluate the diagnostic accuracy of a novel qualitative in vitro urinary test, the Xpert® Bladder Cancer Monitor, compared to cystoscopy and urinary cytology as the gold standard for bladder cancer surveillance at a single institution.
Ethics approval
Local Ethical Committee of the Medical University Innsbruck, 12/05/2016, ref: AN2016-0056; 360/4.7 and 368/5.12 (3954a)
Study design
Prospective single-centre case series diagnostic accuracy study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Non-muscle invasive bladder cancer
Intervention
Following provision of informed consent to participate, participants attend routine appointments as part of their usual care every three months for the first two years after first diagnosis of bladder cancer, then every six months for the fifth year, and yearly thereafter. At these appointments, participants undergo the following procedures:
Urinary cytology:
Urine cytology is a test to look for abnormal cells in the voided urine and bladder washing. The cytopathological Evaluation will be performed according to the Paris Classification System including 7 diagnostic categories.
Cystoscopy:
A cystoscope is a thin tube with a camera and light on the end. During a cystoscopy, this tube is inserted through the urethra transurethrally and into the bladder, analyzing und visualizing the inside of the bladder. The Urethra is the tube that carries urine out of your bladder. Magnified images from the camera are displayed on a screen where your doctor can see them.
Xpert Bladder Cancer Monitor test:
3 ml of voided urine is inserted in the Xpert reagens kit within one hour after urine sample collection. Then, 4 ml of the mixture is inserted into the self-contained PCR cartridge before the RT-PCR can be started. The results will be provided after approximately 90 minutes. 5 mRNA Targets will be measured by RT-PCR.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Diagnostic accuracy of the Xpert Bladder Cancer monitor to detect bladder cancer recurrence is assessed by measuring sensitivity, specificity, NPV and PPV
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2016
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years and over
2. Previous history of non-muscle invasive bladder cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Muscle-invasive bladder cancer
2. Primary diagnosis of bladder cancer
3. Aged under 18 years
Recruitment start date
01/01/2017
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Austria
Trial participating centre
Medical University Innsbruck
Department of Urology
Anichstraße 35
Innsbruck
6020
Austria
Sponsor information
Organisation
Medical University Innsbruck
Sponsor details
Anichstrasse 35
Innsbruck
6020
Austria
+43 (0)512 90030
renate.pichler@i-med.ac.at
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Medical University Innsbruck
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Renate Pichler, Medical University Innsbruck, Department of Urology, Anichstreet 35, A-6020 Innsbruck.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28941000