Actively Recruiting
Longitudinal Bladder Cancer Study for Tumour Recurrence
Led by Pacific Edge Limited · Updated on 2025-11-10
450
Participants Needed
7
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Longitudinal Bladder Cancer Study for Tumour Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Low-, intermediate-, and high-risk patients previously diagnosed with urothelial carcinoma within the last 3 years
- Agree to attend 4 successive study visits with urine sample collection
- Physically able to provide a voided urine sample (not catheterized)
- Able to give written informed consent
- Willing and able to comply with study requirements
- Aged 18 years or older
You will not qualify if you...
- Patients who have had total bladder removal, neo-bladder, or ileal conduit
- History of muscle invasive bladder tumor (pT2 or greater)
- Known pregnancy
- Recent genitourinary procedures within 14 days before urine collection
- Active urinary tract infection within 14 days before urine collection
- Intravesical immunotherapy or chemotherapy within the previous 6 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Miami VA Healthcare System
Miami, Florida, United States, 33125
Actively Recruiting
2
James A. Haley Veteran's Hospital
Tampa, Florida, United States, 33612
Actively Recruiting
3
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States, 29401
Actively Recruiting
4
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
White River Junction Veterans Affair Medical Center
White River Junction, Vermont, United States, 05009
Actively Recruiting
6
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Actively Recruiting
7
Monash Health - Moorabbin Hospital
Clayton, Victoria, Australia, 3165
Actively Recruiting
Research Team
D
Donna Smith, MSc (Hons)
CONTACT
A
Alexis White
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here