Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design ("STRATA Study")
Description
Brief 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.
Detailed 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.
Phase
N/AInclusion and Exclusion 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.