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Bladder EpiCheck European Haematuria Study

NCT06818136 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-01-22

No results posted yet for this study

Summary

The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.

Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.

Conditions

  • Hematuria
  • Cystoscopy
  • Urothelial Carcinoma Bladder
  • Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Urothelial Carcinoma of the Urinary Bladder

Interventions

DIAGNOSTIC_TEST

Bladder EpiCheck

The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.

Sponsors & Collaborators

  • Nucleix Ltd.

    lead INDUSTRY

Principal Investigators

  • Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS · Western General Hospital, Edinburgh

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • United Kingdom

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 NCT06818136 on ClinicalTrials.gov