Actively Recruiting

Age: 45Years +
All Genders
NCT06818136

Bladder EpiCheck European Haematuria Study

Led by Nucleix Ltd. · Updated on 2026-01-22

800

Participants Needed

5

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Bladder EpiCheck European Haematuria Study

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 45 years or older
  • Willing and able to provide written informed consent and follow study procedures
  • Presenting with visible or non-visible haematuria within 6 months before enrollment
  • Scheduled for standard cystoscopy within 60 days after enrollment
  • Able to provide at least 10 ml of voided urine
Not Eligible

You will not qualify if you...

  • History of urothelial cancer in bladder or upper urinary tract
  • Cystoscopy for haematuria within the past 2 years
  • Previously enrolled in this study
  • Treated for prostate cancer within the last 12 months
  • Treated for kidney cancer within the last 12 months
  • Untreated urinary tract infection
  • Symptomatic urinary tract stones (e.g., flank pain)
  • On dialysis for end stage renal failure
  • Has a long term urinary catheter
  • Pregnancy (self-reported)
  • Medical status or frailty prevents completion of the diagnostic pathway

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

NHS Fife

Dunfermline, Fife, United Kingdom, KY12 OSU

Actively Recruiting

2

Addenbrooke's Hospital

Cambridge, United Kingdom

Actively Recruiting

3

NHS Lothian

Edinburgh, United Kingdom

Actively Recruiting

4

Guy's and St Thomas

London, United Kingdom

Actively Recruiting

5

Frimley

Surrey Quays, United Kingdom

Actively Recruiting

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Research Team

V

Vered Yayon

CONTACT

A

Admin.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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