None listed
Conditions
Brief summary
The purpose of this study is to determine how well the Cxbladder urine test detects bladder cancer in patients who have blood in their urine. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have recently been confirmed to have blood in your urine. Study details All participants will be asked to provide a urine sample, to be used for standard urine testing and the Cxbladder test. Cxbladder results will not be shared, and will not affect the treatment or further diagnostic procedures provided to participants. Instead, participants will be diagnosed and treated as per current standard of care. Medical records will be reviewed for up to 12 months in order to compare the standard-of-care diagnosis with the Cxbladder diagnosis. It is hoped that this study will show how well the Cxbladder test is able to diagnose bladder cancer compared to current standard practices, and lead to improved bladder cancer testing services available for people who have blood in their urine.
Interventions
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 substanc
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.
Patients will be recruited from those presenting with haematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of haematuria.
A urine sample will be collected and submitted to the Pacific Edge Diagnostics New Zealand and USA (PEDNZ/PEDUSA) laboratories for the Cxbladder test. The Cxbladder test is a diagnostic test developed to determine the presence or absence
Patients will be recruited from those presenting with haematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of haematuria. A urine sample will be collected and submitted to the Pacific Edge Diagnostics New Zealand and USA (PEDNZ/PEDUSA) laboratories for 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. Some of the urine sample collected will be used to test a new composition preservation buffer (the results will be directly compared to those of the Cxbladder test) and to perform exploratory research on protein biomarkers for urothelial carcinoma (UC) at PEDNZ. After sampling, participants are undergoing standard of care and, for those participants where bladder cancer was not diagnosed following cystoscopy, their medical records will be reviewed 12 months after the initial Cxbladder urine sample was provided. This is to provide a safety follow-up to determine if any further investigations for haematuria that led to a diagnosis of bladder cancer occurred within 12 months of the original Cxbladder sample. As an observational study, Cxbladder results will not be shared with sites/participants and will not influence standard of care.
Sponsors
Pacific Edge PTY Limited
Pacific Edge (Australia) Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed