Bladder EpiCheck Product Development 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.

Recruiting

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Key information

Conditions

Suspicion of Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases NMIBC Surveillance Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Om Research LLC, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

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

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

Treatment and study plan

Bladder EpiCheck

Diagnostic Test

Methylation biomarker urine test

Primary outcomes

The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study.

Time frame: 1 year

The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. For each product development protocol a pre-specified primary endpoint will be defined in a dedicated SAP. For example, validation of a new PCR platform will assess the rate of agreement between the approved PCR platform and the new new platform.

Study contacts

Contact information is provided by the study sponsor or research team.

Limor Klein, PhD

CONTACT

[email protected]

+972-8-9161616

Sponsors and collaborators

Lead sponsor

Nucleix Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 7, 2026
Registry last updated: Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting