NCT05080998Active, not recruiting
Longitudinal Bladder Cancer Study for Tumour Recurrence
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 5 Oct 2021
- Start date
- Jun 2022
- Primary completion date
- Oct 2027
- Lead sponsor
- Pacific Edge Limited
- Diseases
- Bladder cancer
- NCT number
- NCT05080998
What you commit to
- Study type: Observational
- Planned participants: 450
- From Jun 2022 to the primary completion date, Oct 2027
- 7 sites in 2 countries
- 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
- Previous muscle invasive bladder tumour (pT2 or greater)
- 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.
- 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.
Other illness
- 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.
Other
- Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
- Known pregnancy
- Deferral Criteria
Who the study is looking for
- Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
- Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
- Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
- Able to give written informed 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 (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health - Moorabbin Hospital Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Ralph H. Johnson VA Health Care System Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Miami VA Healthcare System Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Washington School of Medicine Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| James A. Haley Veteran's Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| White River Junction Veterans Affair Medical Center 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.