STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

Urothelial Carcinoma Clinical Trial

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")

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03988309
• Other study ID #: CXB/2019/US
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Pacific Edge Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 554
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hematuria
• Urothelial Carcinoma

Intervention

Diagnostic Test:
• Cxbladder
The Cxbladder Triage test result will be provided to physicians for all "low risk" subjects on the test arm. If a "low risk" subject has a Cxbladder Triage negative test result then the indication is to rule out the subject without further assessment. The decision to rule-out or further evaluate is solely that of the physician and subject. If the "low risk" subjects are not Cxbladder Triage negative then a Cxbladder Detect test result will also be provided. The indication is further evaluation as per standard of care. "Not low risk" patients will be evaluated as per standard of care.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre Victoria Hospital	London	Ontario
Canada	The prostate centre- Diamond Health care centre	Vancouver	British Columbia
United States	Accellacare	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Division of urology, Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Institute of Urology, USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Allina Health Cancer Institute	Minneapolis	Minnesota
United States	University of Minnesota, Department of Urology	Minneapolis	Minnesota
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Department of Urology,Vanderbilt University	Nashville	Tennessee
United States	UTHSA - Mays Cancer Center	San Antonio	Texas
United States	Avant Concierge Urology	Winter Garden	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Edge Limited

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder Triage is used in the evaluation	To evaluate the increase in utility as defined by the reduction in cystoscopy procedure count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis. The gold standard for determination of a confirmed clinical diagnosis is cystoscopy confirmed by pathology, plus imaging or any follow-up investigations relating to the visit.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	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.	To evaluate the increase in utility as defined by the reduction in total procedures (and the invasive procedures subgroup) count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	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	To quantify the false negative rate (the percentage of the negative fraction 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	The outcome measure will be assessed by 6 months after trial completion.
Secondary	To clinically validate the performance characteristics and test negative rate of the Cxbladder Detect+ test.	The Cxbladder Detect+ test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity, specificity, positive and negative predictive value and test negative rate of the Cxbladder Detect+ test for detecting urothelial cancer in patients referred for evaluation of hematuria.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	Quantify performance characteristics of Cxbladder signatures including for the detection of high grade/stage UC.	The Cxbladder signature test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity, specificity, positive and negative predictive value of the Cxbladder signature tests for detecting urothelial cancer in patients referred for evaluation of hematuria.	The outcome measure will be assessed by 6 months after trial completion.