Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design ("STRATA Study")

  • STATUS
    Recruiting
  • End date
    Dec 17, 2024
  • participants needed
    600
  • sponsor
    Pacific Edge Limited
Updated on 17 October 2022
transurethral resection of bladder tumor

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.

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.

Details
Condition Hematuria, Urothelial Carcinoma
Treatment Cxbladder
Clinical Study IdentifierNCT03988309
SponsorPacific Edge Limited
Last Modified on17 October 2022

Eligibility

Yes No Not Sure

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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