Bladder Cancer Clinical Trial

STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

600

Study ID:

NCT03988309

Recruitment Status:

Recruiting

Sponsor:

Pacific Edge Limited

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There are 12 Locations for this study

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Institute of Urology, USC Norris Comprehensive Cancer Center
Los Angeles California, 90089, United States More Info
Ileana Aldana
Contact
323-865-0702
[email protected]
Hooman Djaladat
Principal Investigator
Avant Concierge Urology
Winter Garden Florida, 34787, United States More Info
Mariah Donnell
Contact
407-547-1654
[email protected]
Sijo J Parekattil, MD
Contact
407-547-1654
[email protected]
Sijo J Parekattil, MD
Principal Investigator
Accellacare
Chicago Illinois, 60515, United States More Info
Maggie Rusiecka
Contact
630-329-9057
[email protected]
Amit Patel
Principal Investigator
Allina Health Cancer Institute
Minneapolis Minnesota, 55407, United States More Info
Lauryn Moquist
Contact
612-863-1664
[email protected]
Riley Johnke
Contact
763-236-7915
[email protected]
Badrinath Konety, MD
Principal Investigator
Charlene Fares, MD
Sub-Investigator
University of Minnesota, Department of Urology
Minneapolis Minnesota, 55455, United States More Info
Tracy M Daye-Groves
Contact
612-626-6661
[email protected]
Hamed Ahmadi
Principal Investigator
Division of urology, Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States More Info
Kathy Lehman
Contact
717-531-5930
[email protected]
Jay Raman
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Jessica Richardson, RN
Contact
843-449-1010
[email protected]
Neal Shore, MD
Principal Investigator
Department of Urology,Vanderbilt University
Nashville Tennessee, 37232, United States More Info
Pamela Steele
Contact
615-343-2120
[email protected]
Kristin Scarpato
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Maricruz Ibarra
Contact
214-645-8787
[email protected]
Yair Lotan, MD
Principal Investigator
UTHSA - Mays Cancer Center
San Antonio Texas, 78229, United States More Info
Karl F Norton
Contact
210-450-9630
[email protected]
Robert Svatek, MD
Principal Investigator
The prostate centre- Diamond Health care centre
Vancouver British Columbia, V5Z1M, Canada More Info
Sarah Charlesworth
Contact
604-875-4111
[email protected]
Peter Black
Principal Investigator
London Health Sciences Centre Victoria Hospital
London Ontario, N6A5W, Canada More Info
Kaydee Connors
Contact
519-685-8455
[email protected]
Jonathan Izawa
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

600

Study ID:

NCT03988309

Recruitment Status:

Recruiting

Sponsor:


Pacific Edge Limited

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