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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/NCT04943380
Registration number
NCT04943380
Ethics application status
Date submitted
2/03/2020
Date registered
29/06/2021
Date last updated
27/10/2023
Titles & IDs
Public title
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
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Scientific title
An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria
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Secondary ID [1]
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CXB/2019/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:
Hematuria
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Urothelial Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Bladder - transitional cell cancer
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Renal and Urogenital
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Other renal and urogenital disorders
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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
patients with hematuria undergoing investigation for UC - 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. Microscopic hematuria is defined as > 3 red blood cells per high-powered microscopy field for a properly collected urine sample.
Diagnosis / Prognosis: Cxbladder
The Cxbladder Detect test, developed by Pacific Edge Ltd (O'Sullivan 2012; Holyoake 2008; National Health Committee 2015b) is a molecular diagnostic test, which consists of five mRNA transcripts measured in a small volume of urine.
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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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Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
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Assessment method [1]
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The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with hematuria
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Timepoint [1]
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The outcome measure will be assessed by 6 months after trial completion.
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Primary outcome [2]
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Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
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Assessment method [2]
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The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
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Timepoint [2]
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Time Frame: The outcome measure will be assessed by 6 months after trial completion.
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Secondary outcome [1]
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Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
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Assessment method [1]
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Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.
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Timepoint [1]
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The outcome measure will be assessed by 6 months after trial completion.
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Secondary outcome [2]
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To compare the theoretical clinical outcome of patients tested using Cxbladder tests
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Assessment method [2]
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To compare the theoretical clinical outcome of patients tested using Cxbladder tests in combination (Triage followed by Detect and / or Resolve) before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.
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Timepoint [2]
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The outcome measure will be assessed by 6 months after trial completion.
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Secondary outcome [3]
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To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy.
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Assessment method [3]
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To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.
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Timepoint [3]
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The outcome measure will be assessed by 6 months after trial completion.
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Secondary outcome [4]
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Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
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Assessment method [4]
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To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015
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Timepoint [4]
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The outcome measure will be assessed by 6 months after trial completion.
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Eligibility
Key inclusion criteria
- Patient is undergoing investigation of recent confirmed hematuria (by either flexible
or rigid cystoscopy/TURBT), including hematuria patients referred due to
suspicious/positive imaging, in order to determine the presence of urothelial
carcinoma.
- 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
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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
- Prior history of bladder malignancy, prostate or renal cell carcinoma
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation,
urethral dilation) in the 14 days before urine collection
- Previous alkylating based chemotherapy
- Known 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
8/11/2019
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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
1/12/2025
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Actual
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Sample size
Target
1000
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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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California
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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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Florida
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Country [3]
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United States of America
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State/province [3]
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Minnesota
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Country [4]
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United States of America
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State/province [4]
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Nebraska
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Oklahoma
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Country [7]
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United States of America
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State/province [7]
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South Carolina
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Country [8]
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United States of America
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State/province [8]
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Vermont
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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
Prospective observational study to validate the performance characteristics and clinical
utility of Cxbladder tests in a Veterans Affairs cohort.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04943380
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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, PhD
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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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Michael Risk
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Address
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Country
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Phone
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(612) 467-5601
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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/NCT04943380
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