Johan Styrke1, Helene Henriksson1, Börje Ljungberg2, Mudhar Hasan3, Ingrid Silfverberg4, Roland Einarsson5, Per-Uno Malmström6, Amir Sherif2. 1. a Sundsvall Hospital, Department of Surgical and Perioperative Sciences, Urology and Andrology , Umeå University , Umeå , Sweden. 2. b Department of Surgical and Perioperative Sciences, Urology and Andrology , Umeå University , Umeå , Sweden. 3. c Department of Urology , Danderyd Hospital , Danderyd , Sweden. 4. d Department of Urology , Enköping Hospital , Enköping , Sweden. 5. e IDL Biotech AB , Stockholm , Sweden. 6. f Department of Surgical Sciences , Urology, Uppsala University , Uppsala , Sweden.
Abstract
OBJECTIVE: The aim of this study was to determine the diagnostic accuracy of UBC® Rapid - a urine-based marker for bladder cancer - in patients with bladder cancer and controls, and to compare the test results across risk groups. MATERIALS AND METHODS: This prospective phase II study was conducted at four Swedish hospitals. UBC Rapid was evaluated in four groups: A, newly diagnosed bladder cancer (n = 94); B, follow-up of non-muscle-invasive bladder cancer (n = 75); C, benign urinary tract diseases (n = 51); and D, healthy controls (n = 50). Tumours were divided into high risk (carcinoma in situ, TaG3, T1, T2 and T3) and low risk (low malignant potential, TaG1 and TaG2). Urine samples were quantitatively analysed by UBC Rapid. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated based on optimal cut-off (receiver operator characteristics curve analysis). A linear regression compared the UBC Rapid results in the different risk groups. RESULTS: The optimal cut-off was 8.1 μg/l. The median UBC Rapid values were 9.3 μg/l [interquartile range (IQR) 30.9] and 4.3 μg/l (IQR 7.8) in patients with positive and negative cystoscopy, respectively (p < .001). The value for group A was 15.6 μg/l (IQR 37.9), group B 5.6 μg/l (IQR 8.6), group C 5.1 μg/l (IQR 9.0) and group D 3.3 μg/l (IQR 7.1). Sensitivity was 70.8%, specificity 61.4%, PPV 71.3% and NPV 60.8%. The high-risk group had significantly higher UBC Rapid values than the low-risk group: 20.5 μg/l (IQR 42.2), sensitivity 79.2% and specificity 61.4% versus 7.0 μg/l (IQR 9.9), sensitivity 60.0% and specificity 61.4% (p = .039). CONCLUSIONS: The UBC Rapid urine-based marker for bladder cancer gave higher values in patients with positive than in those with negative cystoscopy. The diagnostic accuracy was better in patients with high-risk than in those with low-risk tumours, and was better during primary detection than during surveillance.
OBJECTIVE: The aim of this study was to determine the diagnostic accuracy of UBC® Rapid - a urine-based marker for bladder cancer - in patients with bladder cancer and controls, and to compare the test results across risk groups. MATERIALS AND METHODS: This prospective phase II study was conducted at four Swedish hospitals. UBC Rapid was evaluated in four groups: A, newly diagnosed bladder cancer (n = 94); B, follow-up of non-muscle-invasive bladder cancer (n = 75); C, benign urinary tract diseases (n = 51); and D, healthy controls (n = 50). Tumours were divided into high risk (carcinoma in situ, TaG3, T1, T2 and T3) and low risk (low malignant potential, TaG1 and TaG2). Urine samples were quantitatively analysed by UBC Rapid. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated based on optimal cut-off (receiver operator characteristics curve analysis). A linear regression compared the UBC Rapid results in the different risk groups. RESULTS: The optimal cut-off was 8.1 μg/l. The median UBC Rapid values were 9.3 μg/l [interquartile range (IQR) 30.9] and 4.3 μg/l (IQR 7.8) in patients with positive and negative cystoscopy, respectively (p < .001). The value for group A was 15.6 μg/l (IQR 37.9), group B 5.6 μg/l (IQR 8.6), group C 5.1 μg/l (IQR 9.0) and group D 3.3 μg/l (IQR 7.1). Sensitivity was 70.8%, specificity 61.4%, PPV 71.3% and NPV 60.8%. The high-risk group had significantly higher UBC Rapid values than the low-risk group: 20.5 μg/l (IQR 42.2), sensitivity 79.2% and specificity 61.4% versus 7.0 μg/l (IQR 9.9), sensitivity 60.0% and specificity 61.4% (p = .039). CONCLUSIONS: The UBC Rapid urine-based marker for bladder cancer gave higher values in patients with positive than in those with negative cystoscopy. The diagnostic accuracy was better in patients with high-risk than in those with low-risk tumours, and was better during primary detection than during surveillance.
Authors: Jan Gleichenhagen; Christian Arndt; Swaantje Casjens; Carmen Meinig; Holger Gerullis; Irina Raiko; Thomas Brüning; Thorsten Ecke; Georg Johnen Journal: Int J Mol Sci Date: 2018-01-11 Impact factor: 5.923
Authors: Rafaela Malinaric; Guglielmo Mantica; Lorenzo Lo Monaco; Federico Mariano; Rosario Leonardi; Alchiede Simonato; André Van der Merwe; Carlo Terrone Journal: Int J Environ Res Public Health Date: 2022-08-05 Impact factor: 4.614