NCT05080998 Longitudinal Bladder Cancer Study for Tumour Recurrence
| NCT ID | NCT05080998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pacific Edge Limited |
| Condition | Urothelial Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2022-06-08 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2022-06-08 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Tony Lough
STUDY CHAIR
Pacific Edge Pty Ltd
Frequently Asked Questions
Who can join the NCT05080998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05080998 currently recruiting?
Yes, NCT05080998 is actively recruiting participants. Contact the research team at donna.smith@pacificedgedx.com for enrollment information.
Where is the NCT05080998 trial being conducted?
This trial is being conducted at Miami, United States, Tampa, United States, Charleston, United States, Dallas, United States and 3 additional locations.
Who is sponsoring the NCT05080998 clinical trial?
NCT05080998 is sponsored by Pacific Edge Limited. The principal investigator is Tony Lough at Pacific Edge Pty Ltd. The trial plans to enroll 450 participants.
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