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STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

NCT03988309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2025-05-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Pacific Edge Limited

    lead INDUSTRY

Principal Investigators

  • Tony Lough, PhD · Pacific Edge Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2024-07-24
Completion
2024-07-24

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988309 on ClinicalTrials.gov