Efficacy and Utility of Cxbladder Tests in Hematuria Patients
DRIVE
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
1 other identifier
observational
682
1 country
10
Brief Summary
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2019
CompletedFirst Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedApril 24, 2026
April 1, 2026
4.2 years
March 2, 2020
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
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.
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 Outcomes (5)
To identify whether patients received a UC diagnosis 6- and 24-months post urine sample collection
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
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.
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.
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
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.
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Veterans Medical Research Foundation
San Diego, California, 92161, United States
Bay Pines Veterans Affairs
Bay Pines, Florida, 33744-8200, United States
South Florida Veterans Affairs
Miami, Florida, 33125, United States
James A Haley Veterans' Hospital
Tampa, Florida, 33612-4745, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
NWIHCS-Omaha VA Medical Center
Omaha, Nebraska, 68105, United States
James J. Peters VAMC
New York, New York, 10468-3904, United States
Oklahoma City VA Hospital
Oklahoma City, Oklahoma, 73104, United States
Medical University of South Carolina
Charleston, South Carolina, 29401, United States
White River Junction VAMC
White River Junction, Vermont, 05009, United States
Biospecimen
A minimum of 30 mL of urine will be required for the sampling system to function. Two 5 mL aliquots of the collected urine will be transferred to a vacutainer containing a preservative reagent, and couriered to Pacific Edge Diagnostic NZ Laboratories.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tony Lough, PhD
Pacific Edge Pty Ltd
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
June 29, 2021
Study Start
November 8, 2019
Primary Completion
January 18, 2024
Study Completion
January 18, 2024
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share