The Cxbladder Hematuria Clinical Utility Study

  • STATUS
    Recruiting
  • days left to enroll
    81
  • participants needed
    600
  • sponsor
    Pacific Edge Limited
Updated on 25 January 2021
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 Hemorrhage, Transitional cell carcinoma, Hematuria, Urothelial Carcinoma, haematuria
Treatment Cxbladder
Clinical Study IdentifierNCT03988309
SponsorPacific Edge Limited
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hematuria or Hemorrhage or Urothelial Carcinoma or Transitional cell carcinoma?
Do you have any of these conditions: Urothelial Carcinoma or haematuria or Hemorrhage or Hematuria or Transitional cell carcinoma?
Patient is undergoing investigation of recent confirmed hematuria (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, prostate or renal cell carcinoma
Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
History of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
Previous alkylating based chemotherapy
Pregnancy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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