Efficacy and Utility of Cxbladder Tests in Hematuria Patients

Completed

Conditions studied: Hematuria, Urothelial Carcinoma

In brief

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

Key facts

Study ID

NCT04943380

Run by

Pacific Edge Limited

People needed

682

Starts

2019-11-08

Expected to finish

2024-01-18

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
• Able to provide a voided urine sample of the required minimum volume
• Able to give written consent
• Able and willing to comply with study requirements
• Aged 18 years or older

You may not qualify if…

• Prior history of bladder malignancy, prostate or renal cell carcinoma
• Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
• Previous alkylating based chemotherapy
• Known Pregnancy.

Where it is running

• Veterans Medical Research Foundation — San Diego, California, United States
• Bay Pines Veterans Affairs — Bay Pines, Florida, United States
• South Florida Veterans Affairs — Miami, Florida, United States
• James A Haley Veterans' Hospital — Tampa, Florida, United States
• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States
• NWIHCS-Omaha VA Medical Center — Omaha, Nebraska, United States
• James J. Peters VAMC — New York, New York, United States
• Oklahoma City VA Hospital — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• White River Junction VAMC — White River Junction, Vermont, United States

Full record on ClinicalTrials.gov

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