Condition category
Cancer
Date applied
03/11/2020
Date assigned
23/12/2020
Last edited
18/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 June 2022

Who is funding the study?
Cepheid Solutions (USA)

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

Trial website

Contact information

Type

Public

Primary contact

Prof Ghulam Nabi

ORCID ID

Contact details

University of Dundee
Ninewells Hospital and Medical School
Scotland
DD1 9SY
United Kingdom
+44 (0)1382660111
g.nabi@dundee.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 273366

Study information

Scientific title

Verification of urinary Xpert bladder cancer detection test in patients with haematuria

Acronym

VIXEN

Study hypothesis

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

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

Study design

Prospective single-centre observational cohort trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

Comparison of the total cost of both diagnosis (cystoscopy and cytology) strategies (with or without Xpert Bladder Cancer Detection), measured at 18 months

Overall trial start date

01/01/2019

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

370

Participant 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

Recruitment start date

01/01/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Tayside
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee

Sponsor details

Tayside Medical Science Centre
Ninewells Hospital and Medical School
R&D Office
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383297
p.burns@dundee.ac.uk

Sponsor type

University/education

Website

https://www.dundee.ac.uk/

Funders

Funder type

Industry

Funder name

Cepheid Solutions

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 statement
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).

Intention to publish date

30/06/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2020: Trial's existence confirmed by South West - Central Bristol Research Ethics Committee.