Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05080998




Registration number
NCT05080998
Ethics application status
Date submitted
5/10/2021
Date registered
18/10/2021
Date last updated
14/09/2022

Titles & IDs
Public title
CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients
Scientific title
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Intermediate and High-Risk Patients
Secondary ID [1] 0 0
CXBM/2021/VA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - CxBladder Monitor

Single arm - Patients undergoing surveillance for UC recurrence - Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Only intermediate and high-risk group, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.


Diagnosis / Prognosis: CxBladder Monitor
CxBladder Monitor (CxbM) is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the proposed pathway failure rate versus the standard of care failure rate.
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
1. High and intermediate risk surveillance subjects with a previous confirmed diagnosis
or recurrence of urothelial carcinoma

2. Subjects must agree to 4 successive visits including urine sample collection at each
of the study visits and records review follow-up

3. Able to provide a voided urine sample (a sample from catheterization is not eligible)
of the required minimum volume

4. Able to give written consent

5. Able and willing to comply with study requirements

6. 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
1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterization,
urethral dilation) in the 14 days before urine collection

2. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits

3. Previous muscle invasive bladder tumour (pT2 or greater)

4. Pregnancy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Vermont
Country [2] 0 0
United States of America
State/province [2] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pacific Edge Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which
is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to
reduce the number of cystoscopies required during post-treatment surveillance. This is a
prospective single arm multi-center study using the diagnostic CxBladder test with subjects
previously diagnosed positive with primary or recurrent UC and who are undergoing a schedule
of investigative cystoscopies and treatment for the possible recurrence of urothelial
carcinoma presenting to qualified sites. To test the pathway multiple consecutive urine
samples will be collected during the course of surveillance and records review follow-up will
also be completed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05080998
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Tony Lough
Address 0 0
Pacific Edge Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexis White, BSc (Hons)
Address 0 0
Country 0 0
Phone 0 0
+64 21 959 001
Fax 0 0
Email 0 0
alexis.white@pacificedgedx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05080998