Longitudinal Bladder Cancer Study for Tumour Recurrence

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

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.

Conditions2

Locations6 sites

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