ACTRN12616001181493Completed未知
An observational study of the performance characteristics including Sensitivity and NPV of the Cxbladder urine test for in the detection of urothelial carcinoma in patients presenting with macroscopic or microscopic haematuria
Pacific Edge Diagnostics Pty Ltd0 sites300 target enrollmentStarted: August 29, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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).
Investigators
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