An observational study of the uRNA-2 urine test for the monitoring of recurrence of urinary tract transitional cell carcinoma (TCC)

Not Applicable

Recruiting

• Conditions: Bladder Cancer; Cancer - Bladder

• Registration Number: ACTRN12612000042842
• Lead Sponsor: Pacific Edge PTY Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Positive primary or recurrence diagnosis for urinary tract TCC within the past 5 years 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.Patient is able to provide a voided urine sample of the required minimum volume
4.Patient is able to give written informed consent
5.Patient is 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the performance characteristics (sensitivity, specificity, area under the ROC curve, positive and negative predictive values) of the uRNA-2 test for the detection of recurrent TCC in patients with history of urinary tract TCC in the last 5 years who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard of recurrence detection to be compared with is cystoscopy.[Patients will provide a urine sample at the time of recruitment or prior to their next scheduled cystoscopy. Additional samples may be taken if the patients re-presents during the study window. No additional visit are required as a result of study participation.<br>Samples are analysed in batches and are not performed in time with clinical work up and are not reported to the clinician.]

Secondary Outcome Measures

Name	Time	Method
To compare the characteristics (sensitivity, specificity, area under the ROC curve, positive and negative predictive values) of the uRNA-2 test for the detection of TCC recurrence to those of NMP22 ELISA assay[Patients will provide a urine sample at the time of recruitment or prior to their next scheduled cystoscopy. Additional samples may be taken if the patients re-presents during the study window. No additional visit are required as a result of study participation.<br>Samples are analysed in batches and are not performed in time with clinical work up and are not reported to the clinician.]