Urinary Xpert bladder cancer detection test in patients with haematuria

ISRCTN	ISRCTN40815027
DOI	https://doi.org/10.1186/ISRCTN40815027
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	273366
Protocol serial number	IRAS 273366
Sponsor	University of Dundee
Funder	Cepheid Solutions

Submission date: 03/11/2020
Registration date: 23/12/2020
Last edited: 27/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In Europe, more than 120,000 people are diagnosed with bladder cancer each year. Early diagnosis is very important to improve the success of treatment for bladder cancers. However, many patients do not have symptoms at early stages, which makes this challenging. One symptom which may be an early sign of bladder cancer is the presence of blood in the urine. 1 in 5 adults with blood in the urine are found to have bladder cancer. However, blood in the urine can also be a symptom of other conditions so bladder cancers are often missed if the blood in the urine is the only symptom. There is a need for a fast, non-invasive test that can detect bladder cancer at early stages. This study is investigating a new test called Xpert Bladder Cancer Detection, which measures genetic markers of bladder cancer. The researchers want to compare the ability of this new test to detect bladder cancer in patients with blood in the urine, compared to the methods that are currently used. A urine cytology test is currently used, which looks for the presence of abnormal cells in a urine sample.

Who can participate?
Patients who have been referred to the urology clinic with blood in their urine

What does the study involve?
Patient attending the clinic for their cystoscopy procedure will be asked for their permission to collect the leftover urine from this visit. The research team will use the collected sample to assess the new system. The participant will continue with their planned clinic visits and procedures. The research team will collect participants' clinical records such as age, gender, smoking history, current medication, medical history, cytology, cystoscopy, imaging and surgical results.

What are the possible benefits and risks of participating
The research team will only collect the leftover urine, minimising participant involvement and risk. Participants will not benefit directly from taking part in this study. The test result will not be used in the treatment care of the patient and there will be no other test performed on the sample provided. However, participation ensures that the researchers progress in the understanding, design and development of a technique which could support the current recommended procedure for bladder cancer diagnosis. Participation will not change participants' planned care and they will be expected to attend all their scheduled clinic appointments.

Where is the study run from?
Perth Royal Infirmary and Ninewells Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2021 to August 2023

Who is funding the study?
Cepheid Solutions (USA)

Who is the main contact?
Prof. Ghulam Nabi
g.nabi@dundee.ac.uk

Contact information

Prof Ghulam Nabi
Public

University of Dundee
Ninewells Hospital and Medical School
Scotland
DD1 9SY
United Kingdom

Phone	+44 (0)1382660111
Email	g.nabi@dundee.ac.uk

Study information

Primary study design	Observational
Study design	Prospective single-centre observational cohort trial
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Verification of urinary Xpert bladder cancer detection test in patients with haematuria
Study acronym	VIXEN
Study objectives	The aim of this study is to test a new bladder cancer detection machine and to determine if this is better than currently used bladder cancer detection methods.
Ethics approval(s)	Approved 24/02/2020, South West - Central Bristol Research Ethics Committee (Whitefriars, Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT, UK; +44 (0)207 1048029; centralbristol.rec@hra.nhs.uk), REC ref: 20/SW/0040
Health condition(s) or problem(s) studied	Suspected bladder cancer
Intervention	Patient attending the clinic for their cystoscopy procedure will be asked for their permission to collect the left-over urine from this visit. The research team will use the collected sample to assess the new non-invasive system for its diagnostic accuracy. The participant will continue with their planned clinic visits and procedures as per their clinical pathway. The research team will collect participants clinical records such as age, gender, smoking history, current medication, medical history, cytology, cystoscopy, imaging and surgical results.
Intervention type	Other
Primary outcome measure(s)	Performance characteristics of Xpert Detection on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting bladder cancer in patients with haematuria: 1. The number of patients correctly diagnosed with bladder cancer in comparison to the Xpert bladder test (true positive) 2. Sensitivity/specificity of the new index test in comparison to histopathology. Sensitivity will use histopathology as standard. Specificity will be calculated by the ability of the Xpert bladder test to rule out false positives in a clinical setting. Measured at 18 months
Key secondary outcome measure(s)	Comparison of the total cost of both diagnosis (cystoscopy and cytology) strategies (with or without Xpert Bladder Cancer Detection), measured at 18 months
Completion date	31/08/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	600
Key inclusion criteria	1. Adults over the age of 18 2. Presenting with visible and non-visible haematuria within 12 weeks of the consent visit 3. Scheduled for a standard of care cystoscopy 4. Agrees to provide voided urine for trial purposes 5. Able to consent
Key exclusion criteria	1. Previous diagnosis of bladder cancer 2. Previous history of kidney stone 3. Indwelling urethral catheter 4. Ongoing urinary tract infection 5. Not able to consent
Date of first enrolment	01/01/2020
Date of final enrolment	30/07/2023

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

NHS Tayside

Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Ghulam Nabi (g.nabi@dundee.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 30/07/2023.
2. The overall trial end date has been changed from 30/06/2022 to 31/08/2023 and the plain English summary has been updated to reflect this change.
3. The target number of participants and the total target enrolment number have been changed from 370 to 600.
02/06/2021: The recruitment end date was changed from 31/12/2020 to 31/12/2021. The sponsor details were updated.
23/11/2020: Trial's existence confirmed by South West - Central Bristol Research Ethics Committee.