A prospective study of a novel urine diagnostic test for the detection of urinary tract transitional cell carcinoma

Pacific Edge Biotechnology Ltd0 sites1,000 target enrollmentJanuary 29, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 29, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Observational

Sex

All

Sponsor

Pacific Edge Biotechnology Ltd

•1\.Patients presenting with a recent history of primary gross haematuria and who require further investigation for possible urological cancer
•2\. No previous investigations for urinary tract cancer or TCC (with the exception of radiological imaging eg CT scan / ultrasound, or bloods)
•3\. Able to provide a voided urine sample
•4\. Able to give written informed consent
•5\. Able and willing to comply with study requirements
•6\. \> 18 years

•Patients will not have any of the following: 1\. Prior history of bladder malignancy, prostate or renal cell carcinoma 2\. Ongoing gross haematuria less than 24 hrs prior to investigation 3\. Prior genitourinary manipulation in the 14 days before urine collection 4\. Current urinary tract infection 5\. Current or known history of urinary tract inflammatory disorder 6\. Active renal disorders which may cause haematuria eg pyelonephritis, glomerulonephritis, nephrosis, or other renal inflammatory disorders 7\. Current or intermittent catheterisation within 5 days of urine sample collection 8\. Recent history of pyelonephritis 9\. Previous alkylating based chemotherapy 10\. History of renal or pelvic trauma within last 3 months 11\. Previous cystoscopy for the investigation of haematuria in the 12 months before enrolment.
•12\. Cystoscopy for any reason in the 6 months before enrolment.