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
  • NTC 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.

Multi-site recruitment of patients in Veterans Affairs.Target number of participants up to four sites is around 450 sequentially recruited patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy.

  • Overall Status
    Recruiting
  • Start Date
    November 8, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

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), and truly have no cancer (negative predictive value; NPV) respectively.

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

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

- History of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis

- Previous alkylating based chemotherapy

- 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: Tony Lough, PhD

Phone: (612) 467-5601

Email: mcrisk@umn.edu

LOCATION

Facility Status Contact
Facility: Veterans Medical Research Foundation
San Diego, California 92161
United States
Status: Recruiting Contact: Contact
Anne Jones
858-642-3407 46260
anne.jones2@va.gov
Facility: Minneapolis VA Health Care System
Minneapolis, Minnesota 55417
United States
Status: Recruiting Contact: Principal Investigator
Kyoko Sakamoto
612-725-2000
yeng.mua@VA.gov
Facility: NWIHCS-Omaha VA Medical Center
Omaha, Nebraska 68105
United States
Status: Recruiting Contact: Contact
Yeng Mua
405-271-8001
felicia-kiplinger@ouhsc.edu
Facility: Oklahoma City VA Hospital
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Principal Investigator
Michael Risk
843-789-7816
Susan.caulder@va.gov
Facility: Medical University of South Carolina
Charleston, South Carolina 29401
United States
Status: Recruiting Contact: Contact
Holly DeSpiegelaere