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Trial registered on ANZCTR


Registration number
ACTRN12618000058279
Ethics application status
Approved
Date submitted
7/12/2017
Date registered
17/01/2018
Date last updated
14/06/2022
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of performance of Cxbladder tests to indicate whether patients are at low or high risk of bladder cancer when presenting with blood in urine.
Scientific title
Diagnostic accuracy study to determine performance of Cxbladder tests to indicate whether patients are at low or high risk of bladder cancer when presenting with blood in urine.
Secondary ID [1] 293466 0
CXB-2016-AUS
Universal Trial Number (UTN)
U1111-1206-0226
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Bladder cancer 305654 0
hematuria 326630 0
Condition category
Condition code
Cancer 304874 304874 0 0
Bladder
Renal and Urogenital 323875 323875 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective study recruiting patients presenting with blood in urine who are undergoing urological investigation for the presence of bladder cancer.

This study is designed to highlight the utility of the Cxbladder tests in an Australian clinical setting by demonstrating performance characteristics in a clinical practice. Results of the Cxbladder test will be correlated with the outcome of investigative cystoscopy, which is the standard of care for patients presenting with blood in urine. A urine sample will be collected prior to the investigative cystoscopy (either immediately prior or several days prior depending on whether the patient is having a flexible or rigid cystscopy).

There are 3 Cxbladder tests to be evaluated in this study,
- Cxbladder Triage, which is designed to rules out the presence of bladder cancer in patients presenting with blood in urine at an early stage, thereby potentially avoiding invasive cystoscopy;
- Cxbladder Detect, which is used in detection of bladder cancer in patients with blood in urine; and
- Cxbladder Resolve is designed to accurately segregate patients being evaluated for blood in urine with a high probability of high grade and/or late stage UC, from patients with low or minimal risk of the disease.

For the patient, each of these test just require a mid-stream urine test for analysis and collection of clinical information. Each algorithm (Detect, Triage & Resolve) uses different combinations of the analysis outputs and clinical data.

The study will be conducted in two stages, Stage 1: patient data and urine sample collection and Stage 2: Review of patient records for patients that had negative cystoscopy result.
Intervention code [1] 299709 0
Diagnosis / Prognosis
Comparator / control treatment
No control group, but the Cxbladder result for each patient will be compared to the result of their investigative cystoscopy (reference standard).
Control group
Active

Outcomes
Primary outcome [1] 304068 0
Diagnostic accuracy (sensitivity and negative predictive value) of the Cxbladder Triage test, in an Australian population, for patients with a recent history of haematuria, when compared to the reference standard, investigative cystoscopy.


Timepoint [1] 304068 0
Patients are assessed at a single point in time (i.e. the time they provide a urine sample and have a cystoscopy) for the purposes of the primary outcome. However, for patients with a negative cystoscopy result, patient records will be reviewed six-twelve months post initial recruitment date to determine whether disease state has changed over time.
Primary outcome [2] 331686 0
To investigate the potential for Cxbladder Triage to rule out patients from having a full workup including cystoscopy, based on the performance of the Cxbladder triage test. The performance outcome for Cxbladder Triage is measured as the number of correctly triaged-out patients and Test Negative Rate (TNR) compared to the validated TNR (40% in a test population).
Timepoint [2] 331686 0
after completion of standard of care workup for all patients (stage I) and after completion of the records review 6-12 months after recruitment (stage II)
Primary outcome [3] 331687 0
To investigate the potential for Cxbladder Detect to replace cytology as an adjunct to cystoscopy, based on the performance of the Cxbladder Resolve test in comparison to cytology performance. The performance outcome for Cxbladder Detect is measured as the number of patients correctly identified as having urothelial carcinoma relative to the design specification of sensitivity and a specificity.
Timepoint [3] 331687 0
after completion of standard of care workup for all patients (stage I) and after completion of the records review 6-12 months after recruitment (stage II)
Secondary outcome [1] 341414 0
Diagnostic accuracy (sensitivity and negative predictive value) of the Cxbladder Resolve test, in an Australian population, for the detection of high grade/late stage UC in patients with a recent history of haematuria, when compared to the reference standard, investigative cystoscopy.
Timepoint [1] 341414 0
Patients are assessed at a single point in time (i.e. the time they provide a urine sample and have a cystoscopy) for the purposes of the primary outcome. However, for patients with a negative cystoscopy result, patient records will be reviewed six-twelve months post initial recruitment date to determine whether disease state has changed over time.
Secondary outcome [2] 410787 0
To compare the performance characteristics of Cxbladder Triage and Cxbladder Detect with results generated at other clinical sites, and to the results of the published clinical validation studies (O’Sullivan et al in 20121 and Kavalieris et al in 20152).
Timepoint [2] 410787 0
after completion of standard of care workup for all patients (stage I) and after completion of the records review 6-12 months after recruitment (stage II)
Secondary outcome [3] 410788 0
To Validate an alternative sample processing methodology to mitigate the impact of bladder inflammation on Cxbladder testing and reporting. The test results from the alternative processing will be compared to the results from the standard clinical workup.
Timepoint [3] 410788 0
after completion of standard of care workup for all patients (stage I) and after completion of the records review 6-12 months after recruitment (stage II)
Secondary outcome [4] 410789 0
To Identify the incidence of UC in samples impacted by inflammation. As a standard process, the central lab checks every urine sample for inflammation upon receipt and would usually reject such samples in a commercial setting. In this study, inflamed samples will instead undergo the an alternative methodology. The number of inflamed samples received will be recorded.
Timepoint [4] 410789 0
after completion of standard of care workup for all patients (stage I) and after completion of the records review 6-12 months after recruitment (stage II)

Eligibility
Key inclusion criteria
- Patient is undergoing investigative cystoscopy for investigation of recent (within the last 3 months) macroscopic or microscopic haematuria
- Patient must be able and willing to comply with study requirements – for Stage I and Stage II of the study.
- Patients must be over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior history of UC.
- Prior genitourinary manipulation in the 14 days before urine collection.
- Current or known history of urinary tract inflammatory disorder.
- Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders.
- Recent history of pyelonephritis.
- Patient is presenting with confirmation of a current urinary tract infection.
- Patient is presenting with confirmation of current bladder or large renal calculi (specifically large/obstructive/inflammatory renal calculi only – patients with small non-obstructive calculi are not to be excluded).
- Prior history (past 12 months of an episode of macroscopic haematuria with confirmed diagnosis (malignant or otherwise).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All enrolled patients that satisfy the protocol requirements will be included in the analysis.
Recruitment target is calculated to be up to 500 patients with haematuria and is required for comparison of the accuracy of Cxbladder and reference tests.

This analysis will initially be completed at the end of Stage I and will then be repeated, incorporating data generated during Stage II of the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2018
Actual
12/02/2018
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
500
Accrual to date
249
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9450 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 9451 0
Redland Hospital - Cleveland
Recruitment hospital [3] 9452 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [4] 22541 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 18176 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 18177 0
4163 - Cleveland
Recruitment postcode(s) [3] 18178 0
4108 - Coopers Plains
Recruitment postcode(s) [4] 37780 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 298090 0
Commercial sector/Industry
Name [1] 298090 0
Pacific Edge Pty Ltd
Country [1] 298090 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pacific Edge Pty Ltd
Address
Suite 4/501 Toorak Road, Toorak VIC 3142
Country
Australia
Secondary sponsor category [1] 297167 0
None
Name [1] 297167 0
Address [1] 297167 0
Country [1] 297167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299168 0
Metro South Health
Ethics committee address [1] 299168 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 299168 0
Australia
Date submitted for ethics approval [1] 299168 0
19/10/2017
Approval date [1] 299168 0
17/11/2017
Ethics approval number [1] 299168 0
HREC/17/QPAH/742

Summary
Brief summary
This study is evaluating the performance of Cxbladder tests in determining whether patients are at low or high risk of bladder cancer when presenting with blood in urine.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and are undergoing investigative cystoscopy at either the Princess Alexandra, Redland, Redcliffe or Queen Elizabeth II hospitals for investigation of recent (within the last 3 months) macroscopic or microscopic haematuria (i.e. blood in urine).

Study details
All participants in this study will undergo a Cxbladder urine diagnostic test as well as standard investigative cystoscopy. Results of both of these tests will then be compared in order to evaluate accuracy of the Cxbladder test.

It is hoped that our study will determine the utility of the Cxbladder urine diagnostic test in an Australian clinical setting by demonstrating performance characteristics while also showing efficacy in clinical practice.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62730 0
Dr Ian Vela
Address 62730 0
Level 3 West,
Translational Research Institute,
37 Kent St,
Brisbane Qld 4102 Australia
Country 62730 0
Australia
Phone 62730 0
+61 7 3176 2111
Fax 62730 0
Email 62730 0
[email protected]
Contact person for public queries
Name 62731 0
Anke Fronius
Address 62731 0
Pacific Edge Pty Ltd
The Centre for Innovation
87 St David Street
PO Box 56, Dunedin, New Zealand 9016
Country 62731 0
New Zealand
Phone 62731 0
+64 27 839 3164
Fax 62731 0
Email 62731 0
[email protected]
Contact person for scientific queries
Name 62732 0
Tony Lough
Address 62732 0
Pacific Edge Limited
Centre for Innovation
87 St David St
PO Box 56
Dunedin,
New Zealand, 9016
Country 62732 0
New Zealand
Phone 62732 0
+64 21 0223 8591
Fax 62732 0
Email 62732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient data will remain confidential. A summary of study findings may be published in the future once analysed.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.