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

INTRODUCTION

  • Org Study ID: CXB/2019/US
  • Secondary ID: N/A
  • NCT 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, as defined by the AUA/SUFU Guideline (Barocas DA, Boorjian SA, Alvarez RD et al. Microhematuria: AUA/SUFU guideline, J Urol 2020; 204:778) (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 or pelvic radiotherapy. Prior history prostate or renal cell carcinoma within the last 5 years.

- * Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,

- * Known current 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: N/A

Email: N/A

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
ileana.aldana@med.usc.edu

Principal Investigator
Hooman Djaladat

Facility: Avant Concierge Urology
Winter Garden, Florida 34787
United States
Status: Recruiting Contact: Contact
Mariah Donnell
407-547-1654
mariah@avantconciergeurol.com

Contact
Sijo J Parekattil, MD
407-547-1654
sijo@avantconciergeurol.com

Principal Investigator
Sijo J Parekattil, MD

Facility: Accellacare
Chicago, Illinois 60515
United States
Status: Recruiting Contact: Contact
Maggie Rusiecka
630-329-9057
maggie.rusiecka@accellacare.com

Principal Investigator
Amit Patel

Facility: Allina Health Cancer Institute
Minneapolis, Minnesota 55407-3799
United States
Status: Recruiting Contact: Contact
Lauryn Moquist
612-863-1664
lauryn.moquist@allina.com

Contact
Riley Johnke
763-236-7915
riley.johnke@allina.com

Principal Investigator
Badrinath Konety, MD

Sub-Investigator
Charlene Fares, MD

Facility: University of Minnesota, Department of Urology
Minneapolis, Minnesota 55455
United States
Status: Recruiting Contact: Contact
Tracy M Daye-Groves
612-626-6661
tmgroves@umn.edu

Principal Investigator
Hamed Ahmadi

Facility: Division of urology, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Status: Recruiting Contact: Contact
Kathy Lehman
717-531-5930
klehman3@pennstatehealth.psu.edu

Principal Investigator
Jay Raman

Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Jessica Richardson, RN
843-449-1010
261
jrichardson@curcmb.com

Principal Investigator
Neal Shore, MD

Facility: Department of Urology,Vanderbilt University
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Contact
Pamela Steele
615-343-2120
pamela.steele@vumc.org

Principal Investigator
Kristin Scarpato

Facility: UT Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Maricruz Ibarra
214-645-8787
58788
Maricruz.Ibarra@UTSouthwestern.edu

Principal Investigator
Yair Lotan, MD

Facility: UTHSA - Mays Cancer Center
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Karl F Norton
210-450-9630
nortonk1@uthscsa.edu

Principal Investigator
Robert Svatek, MD

Facility: The prostate centre- Diamond Health care centre
Vancouver, British Columbia V5Z1M9
Canada
Status: Recruiting Contact: Contact
Sarah Charlesworth
604-875-4111
69308
scharlesworth@prostatecentre.com

Principal Investigator
Peter Black

Facility: London Health Sciences Centre Victoria Hospital
London, Ontario N6A5W9
Canada
Status: Recruiting Contact: Contact
Kaydee Connors
519-685-8455
56366
kaydee.connors@lhsc.on.ca

Principal Investigator
Jonathan Izawa