Condition category
Cancer
Date applied
11/03/2017
Date assigned
15/03/2017
Last edited
25/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Renate Pichler

ORCID ID

Contact details

Medical University Innsbruck
Anichstraße 35
Innsbruck
6020
Austria

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 measures

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

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

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28941000

Publication citations

Additional files

Editorial Notes

25/09/2017: Publication reference added.