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Clinical Trials/ACTRN12618000058279
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.

Registry
who.int
Start Date
January 17, 2018
End Date
TBD
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pacific Edge Pty Ltd

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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