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Brief Title: Efficacy and Utility of Cxbladder Tests in Hematuria Patients

An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria

INTRODUCTION

  • Org Study ID: CXB/2019/VA
  • Secondary ID: N/A
  • NCT ID: NCT04943380
  • Sponsor: Pacific Edge Limited

BRIEF SUMMARY

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

DETAILED DESCRIPTION

Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.

The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites

  • Overall Status
    Active, not recruiting
  • Start Date
    November 8, 2019
  • Phase
  • Study Type
    Observational

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 (by either flexible or rigid cystoscopy/TURBT), including hematuria patients 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

- * Previous alkylating based chemotherapy

- * Known 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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