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Trial registered on ANZCTR


Registration number
ACTRN12622001127796p
Ethics application status
Submitted, not yet approved
Date submitted
11/08/2022
Date registered
16/08/2022
Date last updated
16/08/2022
Date data sharing statement initially provided
16/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study to determine how well the Cxbladder urine test detects bladder cancer in patients presenting with blood in their urine
Scientific title
An observational study of Cxbladder performance for the detection of urothelial carcinoma in patients presenting with haematuria
Secondary ID [1] 307747 0
CXB/2022/AUHAEM
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Hematuria 326336 0
Urothelial Carcinoma 326337 0
Condition category
Condition code
Cancer 323646 323646 0 0
Bladder
Renal and Urogenital 323647 323647 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
Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria.

A urine sample will be collected and submitted to the central lab for central cytology and the Cxbladder test. The Cxbladder test is a diagnostic test developed to determine the presence or absence of bladder cancer by testing for substances that are produced by cancer cells and can be found in the voided urine sample. After sampling, participants are undergoing standard of care and their medical records will be reviewed for up to 24 months. Cxbladder results will not be shared with sites/participants.
Intervention code [1] 323599 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will be on standard of care, which involves a cystoscopy. During a cystoscopy, a small camera (the cystoscope) is inserted through the urethra into the bladder to visually check for abnormal areas. Depending on presentation and procedures already performed in the primary care setting, additional procedures may include further imaging procedures and urine tests.
Central test results (central cytology and Cxbladder result) will not be communicated to the investigator site or patient. For determine Cxbladder test performance, the results will be compared to the standard of care clinical outcome.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331391 0
Cxbladder test SENSITIVITY will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [1] 331391 0
Urine sampling for the Cxbladder test is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder test and standard-of-care diagnosis are then compared.
Primary outcome [2] 332303 0
Cxbladder test SPECIFICITY will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [2] 332303 0
Urine sampling for the Cxbladder test is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder test and standard-of-care diagnosis are then compared.
Primary outcome [3] 332304 0
Cxbladder test NEGATIVE PREDICTIVE VALUE (NPV) will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [3] 332304 0
Urine sampling for the Cxbladder test is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder test and standard-of-care diagnosis are then compared.
Secondary outcome [1] 409696 0
SENSITIVITY of Cxbladder SIGNATURES (modified Cxbladder tests using the same urine sample) will be be determined by comparison of the test result to the standard of care diagnosis through white light cystoscopy.
Timepoint [1] 409696 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are then compared.
Secondary outcome [2] 412760 0
Determining the SENSITIVITY of Cxbladder signatures for the detection of UPPER TRACT urothelial carcinoma are determined by comparing the Cxbladder result to the standard of care diagnosis.
Timepoint [2] 412760 0
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder and standard-of-care diagnosis are then compared.
Secondary outcome [3] 412761 0
Performance characteristics of Cxbladder signatures are evaluated by comparing result of this study to the Cxbladder performance characteristics of other studies using Cxbladder.
Timepoint [3] 412761 0
Urine sampling for the Cxbladder signature tests is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
Comparison is performed when other study results are available.
Secondary outcome [4] 412910 0
Primary Outcome: Cxbladder test POSITIVE PREDICTIVE VALUE (PPV) will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [4] 412910 0
Urine sampling for the Cxbladder test is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder test and standard-of-care diagnosis are then compared.
Secondary outcome [5] 412911 0
SPECIFICITY of Cxbladder SIGNATURES (modified Cxbladder tests using the same urine sample) will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [5] 412911 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are then compared.
Secondary outcome [6] 412912 0
The NPV of Cxbladder SIGNATURES (modified Cxbladder tests using the same urine sample) will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [6] 412912 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are
Secondary outcome [7] 412913 0
The PPV of Cxbladder SIGNATURES (modified Cxbladder tests using the same urine sample) will be be determined by comparison of the test result to the standard of care diagnosis through white lite cystoscopy. The rule-out rate is determined by determining the rate of negative Cxbladder results amongst all tested patients.
Timepoint [7] 412913 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are
Secondary outcome [8] 412914 0
The rule-out rate of Cxblader signatures is investigated by determining the rate of negative Cxbladder signature results amongst all tested patients.
Timepoint [8] 412914 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
Secondary outcome [9] 412915 0
Determining the SENSITIVITY of Cxbladder signatures for the detection of UPPER TRACT urothelial carcinoma are determined by comparing the Cxbladder result to the standard of care diagnosis.
Timepoint [9] 412915 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are then compared.
Secondary outcome [10] 412916 0
Determining the SPECIFICITY of Cxbladder signatures for the detection of UPPER TRACT urothelial carcinoma are determined by comparing the Cxbladder result to the standard of care diagnosis.
Timepoint [10] 412916 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are then compared.
Secondary outcome [11] 412917 0
Determining the NPV of Cxbladder signatures for the detection of UPPER TRACT urothelial carcinoma are determined by comparing the Cxbladder result to the standard of care diagnosis.
Timepoint [11] 412917 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are then compared.
Secondary outcome [12] 412918 0
Determining the PPV of Cxbladder signatures for the detection of UPPER TRACT urothelial carcinoma are determined by comparing the Cxbladder result to the standard of care diagnosis.
Timepoint [12] 412918 0
Urine sampling for the Cxbladder signature is performed at the first visit before cystoscopy and sent to the Pacific Edge Diagnostics Lab for analysis.
The standard-of care diagnosis is collected via eCRF which is completed by investigator site staff based on the study subject's medical charts as soon as the standard-workup for the patient has been completed and a diagnosis (i.e., Urothelial Carcinoma or no Urothelial Carcinoma) has been made. The Cxbladder signature and standard-of-care diagnosis are then compared.

Eligibility
Key inclusion criteria
- Patient is undergoing investigation of recent confirmed haematuria (by either flexible or rigid cystoscopy/TURBT), including haematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma (UC).
- Able to provide a voided urine sample of the required minimum volume
- Able to give written consent
- Able and willing to comply with study requirements
- Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior history of bladder malignancy, prostate or renal cell carcinoma
- Genitourinary manipulation (flexible or rigid cystoscopy/catheterization, urethral dilation) in the 14 days before urine collection
- Known current pregnancy.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All enrolled patients that satisfy the protocol requirements and have a valid urine sample and confirmed UC status (positive/negative) will be included in the analysis. If we Assuming that the true sensitivity of the test is 97%, then the probability that the lower bound of the 90% Agresti-Coull confidence interval (CI) for the sensitivity will be greater than 83% is 80%, if we have approximately 35 cases in the trial. With an assumed incidence for Urothelial Carcinoma of 5%, we would need a total of 700 samples. We aim to recruit until we have 35 confirmed cases of UC.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22950 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 38256 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 311449 0
Commercial sector/Industry
Name [1] 311449 0
Pacific Edge Pty Ltd
Country [1] 311449 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pacific Edge PTY Limited
Address
4/501 Toorak Road
Toorak
VIC 3142
Country
Australia
Secondary sponsor category [1] 312845 0
Commercial sector/Industry
Name [1] 312845 0
Pacific Edge PTY Ltd
Address [1] 312845 0
4/501 Toorak Road
Toorak
VIC 3142
Country [1] 312845 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310922 0
Monash Health Research Support Services
Ethics committee address [1] 310922 0
Ethics committee country [1] 310922 0
Australia
Date submitted for ethics approval [1] 310922 0
22/07/2022
Approval date [1] 310922 0
Ethics approval number [1] 310922 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119358 0
Mr Tony Lough, PhD
Address 119358 0
Pacific Edge Pty Ltd
4/501 Toorak Road
Toorak
VIC 3142

C/O Tony Lough
Centre for Innovation
87 St David St
PO Box 56
Dunedin,
New Zealand, 9016
Country 119358 0
New Zealand
Phone 119358 0
+64 21 02238591
Fax 119358 0
Email 119358 0
tony.lough@pelnz.com
Contact person for public queries
Name 119359 0
Tony Lough, PhD
Address 119359 0
Pacific Edge Pty Ltd
4/501 Toorak Road
Toorak
VIC 3142

C/O Tony Lough
Centre for Innovation
87 St David St
PO Box 56
Dunedin,
New Zealand, 9016
Country 119359 0
New Zealand
Phone 119359 0
+64 21 02238591
Fax 119359 0
Email 119359 0
tony.lough@pelnz.com
Contact person for scientific queries
Name 119360 0
Tony Lough, PhD
Address 119360 0
Pacific Edge Pty Ltd
4/501 Toorak Road
Toorak
VIC 3142

C/O Tony Lough
Centre for Innovation
87 St David St
PO Box 56
Dunedin,
New Zealand, 9016
Country 119360 0
New Zealand
Phone 119360 0
+64 21 02238591
Fax 119360 0
Email 119360 0
tony.lough@pelnz.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.