None listed
Conditions
Brief summary
This study aims to investigate the diagnostic test accuracy of Cxbladder for diagnosis of bladder cancer in patients presenting with macroscopic or microscopic haematuria. Who is it for? You may be eligible to join this study if you are aged between 18 years or over and are to undergo an investigative cystoscopy for recent macroscopic or microscopic haematuria (presence of red blood cells in the urine) and do not have a prior history of urothelial carcinoma of the bladder. Study details All participants of this study will provide urine samples just prior to undergoing cystoscopy. These samples will be analysed using Cxbladder diagnostic test and results compared with pathology results from samples collected during cystoscopy. These findings will not be used in treatment decisions but will help establish if Cxbladder test can be used in diagnosis of bladder cancer.
Interventions
This study is an observational study of a molecular diagnostic test, Cxbladder used in the detection of Urothelial Carcinomas (UC) in patients presenting with macroscopic or microscopic haematuria. Cxbladder is a diagnostic urine based test, which quantifies 5 RNA biomarkers present at elevated levels in the urine of patients with UC. A midstream urine sample is collected from the patient as part of standard care. A 5 ml aliquot of this sample is stabilised with Cxbladder proprietary liquid buff
This study is an observational study of a molecular diagnostic test, Cxbladder used in the detection of Urothelial Carcinomas (UC) in patients presenting with macroscopic or microscopic haematuria. Cxbladder is a diagnostic urine based test, which quantifies 5 RNA biomarkers present at elevated levels in the urine of patients with UC. A midstream urine sample is collected from the patient as part of standard care. A 5 ml aliquot of this sample is stabilised with Cxbladder proprietary liquid buffer stabilisation solution and sent to a central laboratory for analysis . The remainder of the urine sample may be used for other diagnostic tests as clinically indicated. This is an observational study. The information collected during the study will not be used in any way to influence the clinical evaluation process or decisions made with regard to any patients enrolled in the study. Samples are analysed and scores determined as below (however no sites are provided with direct patient scores). Score <0.12 NPV of 97%, High probability of no urothelial carcinoma 0.12 < Score < 0.23 NPV of 94%, Low probability of urothelial carcinoma but suggests further clinical investigation needed Score > 0.23 PPV of 68%, High probability of urothelial carcinoma The study is observational only and results are only provided to the site after the study is closed and for the purpose of collating data for publication.
Sponsors
Pacific Edge Diagnostics Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient is undergoing investigative cystoscopies for investigation of recent macroscopic or microscopic haematuria Patient must be able and willing to comply with study requirements. Patients must be over 18 years of age.
Exclusion criteria
Prior history of urotherial carcinoma. Prior genitourinary manipulation in the 14 days before urine collection. Current or known history of urinary tract inflammatory disorder. Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders. Recent history of pyelonephritis. Patient is presenting with symptoms indicative of a current urinary tract infection. Patient is presenting with symptoms indicative of bladder or renal calculi. Prior history (past 12 months of an episode of macroscopic haematuria with confirmed diagnosis (malignant or otherwise).
Outcome results
None listed