Bladder EpiCheck urine test development
Official title: Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
Run by Nucleix Ltd. · NCT07514143 · Data updated 2026-11-12
This single-visit project will try the Bladder EpiCheck urine test in adults who are suspected of having a bladder tumor or who are under surveillance for non–muscle-invasive bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Nucleix Ltd. Industry-sponsored |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT07514143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22 or older who are scheduled to undergo TURBT or cystoscopy for a suspected bladder tumor or for NMIBC surveillance within 60 days and who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with known or prior muscle-invasive bladder cancer, recent (past 2 years) treatment for prostate cancer or RCC, or those recently enrolled in the same protocol are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational, single-visit effort to support development of the Bladder EpiCheck kit by collecting voided urine samples and basic clinical data. Eligible adults provide informed consent and a urine sample prior to a planned TURBT or cystoscopy within 60 days, and demographic and pathology information is recorded if available. Patients with known muscle-invasive disease or recent treatment for prostate cancer or RCC are excluded, and repeat enrollment within 60 days is not allowed. No investigational treatments are given; the protocol is limited to sample and data collection to characterize the test's performance.
Why it matters
Potential benefit: If successful, the test could detect tumor-associated signals in urine and help reduce reliance on invasive procedures for diagnosis or surveillance.
How similar studies have gone: Prior published studies of methylation-based urine tests, including earlier EpiCheck work, have shown promising accuracy for detecting recurrence in NMIBC surveillance.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Om Research LLC
San Diego, California, United States Recruiting -
Chesapeake Urology Research Associates
Towson, Maryland, United States Recruiting
Study contacts
- Study coordinator: Limor Klein, PhD
- Email: limor.k@nucleix.com
- Phone: +972-8-9161616
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.