Monitoring bladder cancer recurrence using urine tests

An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients

This study is testing a urine test to see if it can help people with bladder cancer avoid invasive procedures while keeping track of their cancer recurrence.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pacific Edge Limited (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 7 sites (Miami, Florida and 6 other locations)
• Trial ID: NCT05080998 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the CxBladder Monitor test for patients with intermediate and high-risk urothelial carcinoma who are under surveillance for cancer recurrence. Participants will provide urine samples during four successive visits, which will be analyzed alongside their medical records over a follow-up period of up to 48 months. The study seeks to reduce the need for invasive cystoscopies by using a non-invasive urinary biomarker to monitor cancer recurrence. The research will involve multiple medical centers, primarily within the Veterans Affairs system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a previous diagnosis of intermediate or high-risk urothelial carcinoma who are currently under surveillance for recurrence.

Not a fit: Patients who have undergone total cystectomy or have a history of muscle-invasive bladder tumors will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the frequency of invasive cystoscopies for bladder cancer patients, improving their quality of life and reducing healthcare costs.

How similar studies have performed: While the use of urinary biomarkers for cancer surveillance is an emerging field, this specific approach using the CxBladder test is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 illeal conduits
2. Previous muscle invasive bladder tumour (pT2 or greater)
3. Known pregnancy

Deferral Criteria

1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.
2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.
3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.

Where this trial is running

Miami, Florida and 6 other locations

• Miami VA Healthcare System — Miami, Florida, United States (RECRUITING)
• James A. Haley Veteran's Hospital — Tampa, Florida, United States (RECRUITING)
• Ralph H. Johnson VA Health Care System — Charleston, South Carolina, United States (RECRUITING)
• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
• White River Junction Veterans Affair Medical Center — White River Junction, Vermont, United States (RECRUITING)
• University of Washington School of Medicine — Seattle, Washington, United States (RECRUITING)
• Monash Health - Moorabbin Hospital — Clayton, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Donna Smith, MSc (Hons)

Conditions: Urothelial Bladder Cancer, Recurrence