Efficacy and Utility of Cxbladder Tests in Hematuria Patients (DRIVE)

April 21, 2026 updated by: Pacific Edge Limited

An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.

The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites

Study Type

Observational

Enrollment (Actual)

682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Veterans Medical Research Foundation
    • Florida
      • Bay Pines, Florida, United States, 33744-8200
        • Bay Pines Veterans Affairs
      • Miami, Florida, United States, 33125
        • South Florida Veterans Affairs
      • Tampa, Florida, United States, 33612-4745
        • James A Haley Veterans' Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • NWIHCS-Omaha VA Medical Center
    • New York
      • New York, New York, United States, 10468-3904
        • James J. Peters VAMC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City VA Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • White River Junction VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will be conducted with all hematuria patients who present to an outpatient clinic to undergo clinical assessment including cystoscopy and who fulfil study requirements. Consented eligible patients will attend their scheduled clinic visit and undergo all standard tests as clinically indicated.

Description

Inclusion Criteria:

  • Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients 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, prostate or renal cell carcinoma
  • Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
  • Previous alkylating based chemotherapy
  • Known Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with hematuria undergoing investigation for UC
Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as ≥ 3 red blood cells per high-powered microscopy field for a properly collected urine sample.
Diagnostic test: Cxbladder
The Cxbladder Detect+ test is a molecular diagnostic test. The test consists of six DNA biomarkers and five RNA biomarkers measured in a small volume of urine. is an enhanced version of the Cxbladder Detect test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Time Frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months)
The Cxbladder 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 and specificity of the Cxbladder test for detecting urothelial cancer in patients with hematuria
From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months)
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
Time Frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
The Cxbladder 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 and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify whether patients received a UC diagnosis 6- and 24-months post urine sample collection
Time Frame: The outcome measure will be assessed by 6- and up to 24-months after trial completion.
To identify by records review within six months and up to 24-months after the initial urine sample collection whether the patient received a diagnosis of UC of the bladder and/or upper tract.
The outcome measure will be assessed by 6- and up to 24-months after trial completion.
Validation of performance characteristics of Cxbladder tests through sub-group analyses
Time Frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
To validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value) and true negative rate of Cxbladder tests through sub-group analysis (gross hematuria; microhematuria; inflammation), in a VA cohort, for patients with a recent history of hematuria who are undergoing investigative cystoscopy.
From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Time Frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.
From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy.
Time Frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.
From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
Time Frame: The outcome measure will be assessed from enrolment to when a UC diagnosis is made or patient is considered UC negative for this trial (maximum period 24-months) and completed following completion of other similar trials.
To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015
The outcome measure will be assessed from enrolment to when a UC diagnosis is made or patient is considered UC negative for this trial (maximum period 24-months) and completed following completion of other similar trials.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Edge Limited

Investigators

  • Study Chair: Tony Lough, PhD, Pacific Edge Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2019

Primary Completion (Actual)

January 18, 2024

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

June 27, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXB/2019/VA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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