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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
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Scientific title
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Intermediate and High-Risk Patients
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Secondary ID [1]
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CXBM/2021/VA
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To determine the proposed pathway failure rate versus the standard of care failure rate.
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Assessment method [1]
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The failure rate will be measured as the proportion of all subjects experiencing a failure event. A failure event for the proposed pathway is defined as any visit where standard of care cystoscopy is confirmed as positive for a given visit when Cxbladder Monitor was negative at the immediate previous visit. A failure event for the standard of care is defined as any visit where standard of care cystoscopy is confirmed as positive for a given visit when standard of care cystoscopy was negative at the immediate previous visit. (The gold standard for determination of a confirmed clinical diagnosis is cystoscopy and any other procedures relating to the visit with confirmation by pathology following review of a biopsy specimen).
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Timepoint [1]
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12 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Vermont
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Country [2]
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United States of America
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State/province [2]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pacific Edge Limited
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05080998
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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Tony Lough
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Address
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Pacific Edge Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alexis White, BSc (Hons)
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Address
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Country
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Phone
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+64 21 959 001
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05080998
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