STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

Completed · Not applicable

Conditions studied: Hematuria, Urothelial Carcinoma

In brief

To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.

Key facts

Study ID

NCT03988309

Run by

Pacific Edge Limited

People needed

554

Starts

2019-09-11

Expected to finish

2024-07-24

Last updated by the study team

2025-05-31

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, as defined by the AUA/SUFU Guideline (Barocas DA, Boorjian SA, Alvarez RD et al. Microhematuria: AUA/SUFU guideline, J Urol 2020; 204:778) (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects 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 or pelvic radiotherapy. Prior history prostate or renal cell carcinoma within the last 5 years.
• Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
• Known current pregnancy

Where it is running

• Institute of Urology, USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Avant Concierge Urology — Winter Garden, Florida, United States
• Accellacare — Chicago, Illinois, United States
• Allina Health Cancer Institute — Minneapolis, Minnesota, United States
• University of Minnesota, Department of Urology — Minneapolis, Minnesota, United States
• Division of urology, Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Department of Urology,Vanderbilt University — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• UTHSA - Mays Cancer Center — San Antonio, Texas, United States
• The prostate centre- Diamond Health care centre — Vancouver, British Columbia, Canada
• London Health Sciences Centre Victoria Hospital — London, Ontario, Canada

Full record on ClinicalTrials.gov

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