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Bladder EpiCheck Product Development Study

NCT07514143 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Bladder EpiCheck

Methylation biomarker urine test

Sponsors & Collaborators

  • Nucleix Ltd.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514143 on ClinicalTrials.gov