None listed
Conditions
Brief summary
This study aims to evaluate the performance of the uRNA-2 test and to compare uRNA-2 with urine cytology and the NMP22 ELISA kit in the investigation of patients with a history of urinary tract TCC who are undergoing monitoring for recurrence of the disease in New Zealand. Urine samples will be taken from patients as part of standard care prior to cystoscopy. An aliquot of this sample will be used for the tests under evaluation in this study. No deviation from patients care will be undertaken as a result of participation in this study. No study results will be communicated to clinicians or patients. This is a pilot study to determine the utility of this test on a monitoring for recurrence population. Prevalence and performance data from this study will be used to adjust the sample size and comparator evaluation of study ACTRN12612000042842.
Interventions
This is a prospective study focussing on patients that are undergoing routine investigative cystoscopies for monitoring of recurrent urinary tract TCC. A routine urine sample taken for local cytology and / or urinalysis at the clinic immediately prior to an investigative cystoscopy for the monitoring of recurrent bladder cancer. An aliquot of this sample is taken for the purposes of this study. Sample is aliquotted and preserved in stabilisation liquids and sent to lab for analysis. Aliquots wil
This is a prospective study focussing on patients that are undergoing routine investigative cystoscopies for monitoring of recurrent urinary tract TCC. A routine urine sample taken for local cytology and / or urinalysis at the clinic immediately prior to an investigative cystoscopy for the monitoring of recurrent bladder cancer. An aliquot of this sample is taken for the purposes of this study. Sample is aliquotted and preserved in stabilisation liquids and sent to lab for analysis. Aliquots will be used for urine cytology, NMP22 ELISA, NMP22 BladderChek and uRNA-2. Patient medical information is obtained. No deviation from standard care is undertaken. Patients may be asked for additional samples if they present for further scheduled cystoscopies within the duration of the study. No additional visits to clinic will be required as a result of participation in the study. Study participation will be at a maximum of 6 months. Study completion will be after the recruitment of 100 patients at a minimum, data collection cleaning and analysis. It is anticipated that the data output will occur before September 2012.
Sponsors
Pacific Edge Ltd
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Positive diagnosis for urinary tract TCC over the past 5 years by; cystoscopy and confirmation by histopathological examination of resected tissue or confirmation by histopathological examination of biopsy tissue 2. Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract TCC at intervals prescribed by clinical practitioner 3. Able to provide a voided urine sample of the required minimum volume 4. Able to give written informed consent 5. Able and willing to comply with study requirements
Exclusion criteria
1. Prior genitourinary manipulation in the 14 days before urine collection, 2. Current symptoms specific to urinary tract infection as evident on preliminary examination 3. Current or known history of urinary tract inflammatory disorder, 4. Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, 5. Recent history of pyelonephritis 6. Total cystectomy of the bladder
Outcome results
None listed