CxBladderLongitudinal Bladder Cancer Study for Tumour Recurrence

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.