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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04943380




Registration number
NCT04943380
Ethics application status
Date submitted
2/03/2020
Date registered
29/06/2021
Date last updated
2/02/2024

Titles & IDs
Public title
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
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
Secondary ID [1] 0 0
CXB/2019/VA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematuria 0 0
Urothelial Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Timepoint [1] 0 0
The outcome measure will be assessed by 6 months after trial completion.
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Time Frame: The outcome measure will be assessed by 6 months after trial completion.
Secondary outcome [1] 0 0
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Timepoint [1] 0 0
The outcome measure will be assessed by 6 months after trial completion.
Secondary outcome [2] 0 0
To compare the theoretical clinical outcome of patients tested using Cxbladder tests
Timepoint [2] 0 0
The outcome measure will be assessed by 6 months after trial completion.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
The outcome measure will be assessed by 6 months after trial completion.
Secondary outcome [4] 0 0
Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
Timepoint [4] 0 0
The outcome measure will be assessed by 6 months after trial completion.

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
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
* Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
* Previous alkylating based chemotherapy
* Known Pregnancy.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
684
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Vermont

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

Ethics approval
Ethics application status

Summary
Brief summary
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
Trial website
https://clinicaltrials.gov/study/NCT04943380
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, PhD
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
Michael Risk
Address 0 0
Country 0 0
Phone 0 0
(612) 467-5601
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04943380