Bladder EpiCheck Product Development Study

Recruiting now

Conditions studied: Suspicion of Bladder Cancer, NMIBC Surveillance

In brief

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.

Key facts

Study ID

NCT07514143

Run by

Nucleix Ltd.

People needed

1000

Starts

2025-09-15

Expected to finish

2026-12-01

Last updated by the study team

2026-04-07

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Om Research LLC — San Diego, California, United States (enrolling)
• Chesapeake Urology Research Associates — Towson, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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