An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
Pacific Edge Limited
Summary
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
Description
This is a multi-site study recruiting subjects from Veterans Affairs and other medical centers. Subjects will be prospectively recruited to an observational study to validate the performance characteristics of CxBladder Monitor test (Monitor) and the second-generation test, CxBladder Monitor Plus (Monitor+). The study will recruit low, intermediate, and high-risk surveillance subjects, defined as per American Urological Association (AUA) / Society of Urologic Oncology (SUO) guidelines 2016 amendment 2020, previously diagnosed with urothelial carcinoma (UC). Eligible subjects will include those…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years. 2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit. 3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible). 4. Able to give written informed consent 5. Able and willing to comply with study requirements 6. Aged 18 years or older Exclusion Criteria: 1. Total cystectomy of the bladder, subjects with neo-bladders or…
Interventions
- Diagnostic TestCxBladder Monitor/Monitor+
CxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.
Locations (7)
- Miami VA Healthcare SystemMiami, Florida
- James A. Haley Veteran's HospitalTampa, Florida
- Ralph H. Johnson VA Health Care SystemCharleston, South Carolina
- UT Southwestern Medical CenterDallas, Texas
- White River Junction Veterans Affair Medical CenterWhite River Junction, Vermont
- University of Washington School of MedicineSeattle, Washington