Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
Nucleix Ltd.
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
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- Diagnostic TestBladder EpiCheck
Methylation biomarker urine test
Locations (2)
- Om Research LLCSan Diego, California
- Chesapeake Urology Research AssociatesTowson, Maryland