STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

NCT03988309 | Completed

• 1 other identifier: CXB/2019/US
• Study Type: interventional
• Target: 554
• Locations: 2 countries
• Sites: 12

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.

Conditions

Hematuria; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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 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.

• 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.

Study Arms (2)

Test, subjects categorised as "low risk" or "Not low risk"

ACTIVE COMPARATOR

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.

Diagnostic Test: Cxbladder

Control

NO INTERVENTION

Subjects on the control arm will be on standard of care. Trial nomogram clinical risk factor categorization for control arm subjects will not be provided to the physician (but appropriate information will be collected on the CRF to enable sub-group analysis) No Cxbladder test results will be provided for control arm subjects. Note that Cxbladder test results will be available for eventual analysis for these subjects.

Interventions

Cxbladder DIAGNOSTIC_TEST

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.

Test, subjects categorised as "low risk" or "Not low risk"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Edge Limited: lead

Study Sites (12)

Institute of Urology, USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

Location

Avant Concierge Urology

Winter Garden, Florida, 34787, United States

Location

Accellacare

Chicago, Illinois, 60515, United States

Location

Allina Health Cancer Institute

Minneapolis, Minnesota, 55407-3799, United States

Location

University of Minnesota, Department of Urology

Minneapolis, Minnesota, 55455, United States

Location

Division of urology, Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Department of Urology,Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UTHSA - Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

The prostate centre- Diamond Health care centre

Vancouver, British Columbia, V5Z1M9, Canada

Location

London Health Sciences Centre Victoria Hospital

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Conditions

Hematuria; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Tony Lough, PhD

  Pacific Edge Pty Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: June 17, 2019
• Study Start: September 11, 2019
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (10)