NCT07514143Recruiting
Bladder EpiCheck Product Development Study
Nucleix Ltd.
Start Date
9/15/2025
Completion Date
12/1/2026
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 Criteria
Age Range: 22 years to No maximum
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_TEST
Bladder EpiCheck
Conditions
Suspicion of Bladder CancerNMIBC Surveillance
Locations
Om Research LLC
San Diego, California 92103
United States
Chesapeake Urology Research Associates
Towson, Maryland 21204
United States