STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

Not Applicable

Active, not recruiting

• Conditions: Hematuria; Urothelial Carcinoma
• Interventions: Diagnostic Test: Cxbladder

• Registration Number: NCT03988309
• Lead 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.

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Study Start: 2019-09-11
• Status Verified: 2023-09
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 554

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test, subjects categorised as "low risk" or "Not low risk"	Cxbladder	A clinical risk factor nomogram risk classification will be used in this study. The nomogram categorizes subjects as either "low risk" or "not low risk" categories. "Low risk" subjects satisfy all conditions and "not low risk" satisfies at least one of the conditions.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. Subjects categorised as "not low risk" will be evaluated as per standard of care. Note that Cxbladder test results will be available for eventual analysis for these subjects.

Primary Outcome Measures

Name	Time	Method
To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder Triage is used in the evaluation	The outcome measure will be assessed by 6 months after trial completion.	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.

Secondary Outcome Measures

Name	Time	Method
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	The outcome measure will be assessed by 6 months after trial completion.	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
Quantify performance characteristics of Cxbladder signatures including for the detection of high grade/stage UC.	The outcome measure will be assessed by 6 months after trial completion.	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.
To clinically validate the performance characteristics and test negative rate of the Cxbladder Detect+ test.	The outcome measure will be assessed by 6 months after trial completion.	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.
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.	The outcome measure will be assessed by 6 months after trial completion.	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.

Trial Locations

Locations (12)

Avant Concierge Urology; 🇺🇸 Winter Garden, Florida, United States

Institute of Urology, USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Accellacare; 🇺🇸 Chicago, Illinois, United States

University of Minnesota, Department of Urology; 🇺🇸 Minneapolis, Minnesota, United States

Allina Health Cancer Institute; 🇺🇸 Minneapolis, Minnesota, United States

Division of urology, Penn State Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Department of Urology,Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

The prostate centre- Diamond Health care centre; 🇨🇦 Vancouver, British Columbia, Canada

UTHSA - Mays Cancer Center; 🇺🇸 San Antonio, Texas, United States

London Health Sciences Centre Victoria Hospital; 🇨🇦 London, Ontario, Canada