A pilot observational study of the uRNA-2 urine test for the detection of urinary tract transitional cell carcinoma (TCC) in patients under a schedule of investigative cystoscopies for monitoring of recurrent TCC.

Not Applicable

Recruiting

• Conditions: Bladder Cancer; Cancer - Bladder

• Registration Number: ACTRN12612000043831
• Lead Sponsor: Pacific Edge 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: 100

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

Study & Design

• Study Type: Observational
• Study Design: Not specified