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Bladder EpiCheck Product Development Study

Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies

Who can join

Ages 22 and older · All sexes

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

About the study

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.

What is being tested

• Bladder EpiCheck (diagnostic test)

Sponsor: Nucleix Ltd. · Participants: 1,000 · Started: Sep 15, 2025

Contact the study team

• Limor Klein, PhD · Phone: +972-8-9161616

Official record on ClinicalTrials.gov — NCT07514143

Locations in the U.S.

Conditions

• Bladder Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.