Bladder EpiCheck Product Development Study

April 5, 2026 updated by: Nucleix Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subjects who are planned to undergo within 60 days either TURBT, cystoscopy and anesthesia or cystoscopy without anesthesia. TURBT and cystoscopy under anesthesia should be due to detection or suspicion of bladder tumor, cystoscopy without anesthesia should be for NMIBC monitoring.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Bladder EpiCheck
Methylation biomarker urine test
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.
Diagnostic test: Bladder EpiCheck
Methylation biomarker urine test
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.
Diagnostic test: Bladder EpiCheck
Methylation biomarker urine test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucleix Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nucleix

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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