NCT04943380Completed
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 682 (actual)
- First submitted
- 2 Mar 2020
- Start date
- 8 Nov 2019
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- Pacific Edge Limited
- Diseases
- Bladder cancer
- NCT number
- NCT04943380
What you commit to
- Study type: Observational
- Participants enrolled: 682
- From 8 Nov 2019 to the primary completion date, 18 Jan 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Known Pregnancy.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bay Pines Veterans Affairs Coordinator of this site? Confirm its status | Bay Pines | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| South Florida Veterans Affairs Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Minneapolis VA Health Care System Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| James J. Peters VAMC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oklahoma City VA Hospital Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| NWIHCS-Omaha VA Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Veterans Medical Research Foundation Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| James A. Haley Veterans Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| White River Junction VAMC Coordinator of this site? Confirm its status | White River Junction | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.