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

INTRODUCTION

  • Org Study ID: CXB/2019/US
  • Secondary ID: N/A
  • NTC 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
    Recruiting
  • Start Date
    September 11, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder is used in the evaluation

Primary Outcome 1 - Timeframe: 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 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

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: 2146458764

Email: yair.lotan@utsouthwestern.edu

LOCATION

Facility Status Contact
Facility: Institute of Urology, USC Norris Comprehensive Cancer Center
Los Angeles, California 90089
United States
Status: Recruiting Contact: Contact
Ileana Aldana
323-865-0702 69308
ileana.aldana@med.usc.edu
Facility: Accellacare
Chicago, Illinois 60515
United States
Status: Recruiting Contact: Principal Investigator
Sumeet Bhanvadia
612-626-6661 56366
Mary.Williams@accellacare.com
Facility: University of Minnesota, Department of Urology
Minneapolis, Minnesota 55455
United States
Status: Recruiting Contact: Contact
Mary Williams
717-531-5930
marle025@umn.edu
Facility: Division of urology, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Status: Recruiting Contact: Principal Investigator
Amit Patel
615-343-2120
klehman3@pennstatehealth.psu.edu
Facility: Department of Urology,Vanderbilt University
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Contact
Bethany Marlette
214-645-8764
pamela.steele@vumc.org
Facility: UT Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Principal Investigator
Badrinath Konety
604-875-4111
jess.ramos@UTSouthwestern.edu
Facility: The prostate centre- Diamond Health care centre
Vancouver, British Columbia V5Z1M9
Canada
Status: Recruiting Contact: Contact
Kathy Lehman
519-685-8455
scharlesworth@prostatecentre.com
Facility: London Health Sciences Centre Victoria Hospital
London, Ontario N6A5W9
Canada
Status: Recruiting Contact: Principal Investigator
Jay Raman

kaydee.connors@lhsc.on.ca