Recruiting

Observational Study

Sponsor:

Nucleix Ltd.

Code:

NCT07514143

Conditions

Suspicion of Bladder Cancer

NMIBC Surveillance

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Bladder EpiCheck

Study Details

Brief 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.

Conditions

Suspicion of Bladder Cancer

NMIBC Surveillance

Study ID

NCT07514143

Start date

Sep 15, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects planned to undergo TURBT due to suspected or detected bladder tumor

Adult subjects planned to undergo TURBT within 60 days due to suspected or detected bladder tumor (e.g., by cystoscopy, cytology, imaging) will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing.

Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor

Adult subjects planned to undergo cystoscopy under general anesthesia ,within 60 days due to suspected bladder tumor will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing.

Subjects planned to undergo cystoscopy for NMIBC surveillance

Adult subjects planned to undergo cystoscopy for NMIBC surveillance ,within 60 days will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing.

Interventions

Bladder EpiCheck

Methylation biomarker urine test

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Limor Klein, PhD

+972-8-9161616limor.k@nucleix.com

Locations

Om Research LLC

Recruiting

San Diego, California, United States, 92103

Contacts

Gavriushina

858.429.7050agavriushina@omclinicaltrials.com

Chesapeake Urology Research Associates

Recruiting

Towson, Maryland, United States, 21204

Contacts

Phelps

410-205-8590stephanie.phelps@chesuro.com

More Information

Sponsor

Nucleix Ltd.

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • EpiCheck
  • Bladder cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nucleix Ltd. on 2026-04-07.