ACTRN12618000058279
Recruiting
N/A
Diagnostic accuracy study to determine performance of Cxbladder tests to indicate whether patients are at low or high risk of bladder cancer when presenting with blood in urine.
Pacific Edge Pty Ltd0 sites500 target enrollmentJanuary 17, 2018
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bladder cancer
- Sponsor
- Pacific Edge Pty Ltd
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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