Study of performance of Cxbladder tests to indicate whether patients are at low or high risk of bladder cancer when presenting with blood in urine.

Not Applicable

Recruiting

• Conditions: Renal and Urogenital - Other renal and urogenital disorders; Bladder cancer; hematuria; Cancer - Bladder

• Registration Number: ACTRN12618000058279
• Lead Sponsor: Pacific Edge Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patient is undergoing investigative cystoscopy for investigation of recent (within the last 3 months) macroscopic or microscopic haematuria
- Patient must be able and willing to comply with study requirements – for Stage I and Stage II of the study.
- Patients must be over 18 years of age.

Exclusion Criteria

- Prior history of UC.
- 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 confirmation of a current urinary tract infection.
- Patient is presenting with confirmation of current bladder or large renal calculi (specifically large/obstructive/inflammatory renal calculi only – patients with small non-obstructive calculi are not to be excluded).
- 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