Bladder Cancer Clinical Trial
STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
Summary
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.
Full Description
Randomised two arm pragmatic clinical study to be conducted at multiple sites in US and Canada. The trial will recruit hematuria subjects, presenting to qualified sites (academic, community), who are being evaluated for urothelial carcinoma (UC). Up to 100 consecutive eligible subjects will be recruited per site.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria
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
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There are 12 Locations for this study
Los Angeles California, 90089, United States More Info
Principal Investigator
Winter Garden Florida, 34787, United States More Info
Principal Investigator
Minneapolis Minnesota, 55407, United States More Info
Principal Investigator
Sub-Investigator
Minneapolis Minnesota, 55455, United States More Info
Principal Investigator
Hershey Pennsylvania, 17033, United States More Info
Principal Investigator
Myrtle Beach South Carolina, 29572, United States More Info
Principal Investigator
Nashville Tennessee, 37232, United States More Info
Principal Investigator
Dallas Texas, 75390, United States More Info
Principal Investigator
San Antonio Texas, 78229, United States More Info
Principal Investigator
Vancouver British Columbia, V5Z1M, Canada More Info
Principal Investigator
London Ontario, N6A5W, Canada More Info
Principal Investigator
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