NCT03988309

STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design ("STRATA Study")

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Pacific Edge Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematuria
• Urothelial Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-11
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2019-06-17
• Last updated: 2025-05-31

Locations

12 sites across 2 countries: United States, Canada