Bladder EpiCheck Product Development Study

Summary

This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance. This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.

Eligibility

Inclusion Criteria:

1. Age 22 or older
2. Willing and able to sign the informed consent form
3. Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:

3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance

Exclusion Criteria:

1. Patients with known or history of muscle invasive bladder cancer (MIBC)
2. Treatment of prostate cancer or RCC in the past 2 years
3. Patients previously enrolled into this study within the prior 60 days

Conditions3

Locations2 sites

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