Clinical trial NCT03988309: STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
Official title: Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design ("STRATA Study")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematuria
Urothelial Carcinoma
Lead sponsor: Pacific Edge Limited
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder Triage is used in the evaluation
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
Secondary outcomes:
measure: To measure the change in total procedure use (and the invasive procedure sub-group) count between control and test arms when Cxbladder is used in the evaluation.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: To measure the number of subjects who were incorrectly diagnosed associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: To clinically validate the performance characteristics and test negative rate of the Cxbladder Detect+ test.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: Quantify performance characteristics of Cxbladder signatures including for the detection of high grade/stage UC.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Institute of Urology, USC Norris Comprehensive Cancer Center
state: California
city: Winter Garden
country: United States
facility: Avant Concierge Urology
state: Florida
city: Chicago
country: United States
facility: Accellacare
state: Illinois
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Urology
state: Minnesota
city: Hershey
country: United States
facility: Division of urology, Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Department of Urology,Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: UTHSA - Mays Cancer Center
state: Texas
city: Vancouver
country: Canada
facility: The prostate centre- Diamond Health care centre
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre Victoria Hospital
state: Ontario
Study officials:
affiliation: Pacific Edge Pty Ltd
name: Tony Lough, PhD
role: STUDY_CHAIR
References: