Bladder EpiCheck Product Development Study
Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
Nucleix Ltd.
1,000 participants
Sep 15, 2025
OBSERVATIONAL
Conditions
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 Criteria4
- Age 22 or older
- Willing and able to sign the informed consent form
- Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:
- 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 Criteria3
- Patients with known or history of muscle invasive bladder cancer (MIBC)
- Treatment of prostate cancer or RCC in the past 2 years
- Patients previously enrolled into this study within the prior 60 days
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Interventions
Methylation biomarker urine test
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07514143