An observational study of the efficacy of the Cxbladder a urine test for the detection of urothelial carcinoma in patients presenting with macroscopic or microscopic haematuria.

Not Applicable

Completed

• Conditions: haematuria; Bladder cancer; Cancer - Bladder

• Registration Number: ACTRN12616001181493
• Lead Sponsor: Pacific Edge Diagnostics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified