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Brief Title: Cxbladder Hematuria Clinical Utility Study

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

INTRODUCTION

  • Org Study ID: CXB/2019/US
  • Secondary ID: N/A
  • NCT ID: NCT03988309
  • Sponsor: Pacific Edge Limited

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    September 11, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Hematuria
  • Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Tony Lough, PhD

Role: Study Chair

Affiliation: Pacific Edge Pty Ltd

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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