Bladder EpiCheck Product Development Study

Conditions

• NMIBC Surveillance
• Suspicion of Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bladder EpiCheck — DIAGNOSTIC_TEST
  Methylation biomarker urine test

Study Details

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 Dates

Start date

Sep 15, 2025

Status verified

Apr 2026

Primary completion

Nov 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.

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

• Limor Klein, PhD
  +972-8-9161616
  [email protected]

Locations (2)

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