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

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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: Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.

Primary Outcome 1 - Timeframe: The outcome measure will be assessed by 6 months after trial completion.

Primary Outcome 2 - Measure: Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV)

Primary Outcome 2 - Timeframe: Time Frame: The outcome measure will be assessed by 6 months after trial completion.

Primary Outcome 3 - Measure: and truly have no cancer (negative predictive value; NPV) respectively.

Primary Outcome 3 - 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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