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Bladder EpiCheck Product Development Study
Sponsor: 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.
Official title: Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2025-09-15
Completion Date
2026-12
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Bladder EpiCheck
Methylation biomarker urine test
Locations (2)
Om Research LLC
San Diego, California, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States