Status:

RECRUITING

Bladder EpiCheck European Haematuria Study

Lead Sponsor:

Nucleix Ltd.

Conditions:

Hematuria

Cystoscopy

Eligibility:

All Genders

45+ years

Brief 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 pres...

Eligibility Criteria

Inclusion Criteria:

  1. Participants aged 45 years or older
  2. Participants who are willing and able to provide written informed consent and adhere to study procedures
  3. Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
  4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
  5. Participants who are able to produce at least 10 ml of voided urine

Exclusion Criteria:

  1. Participants with history of urothelial cancer in the bladder and/or upper urinary tract
  2. Participants who had prior cystoscopy for haematuria within the past 2 years
  3. Participants previously enrolled in this study
  4. Participants treated for prostate cancer within the last 12 months
  5. Participants treated for kidney cancer within the last 12 months
  6. Participants with untreated urinary tract infection
  7. Participants with symptomatic urinary tract stones (e.g. flank pain)
  8. Participants on dialysis for end stage renal failure
  9. Participants with a long term urinary catheter
  10. Pregnancy (self-reported)
  11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway

Key Trial Info

Start Date :

June 20 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT06818136

Start Date

June 20 2025

End Date

December 1 2026

Last Update

January 22 2026

Active Locations (5)

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Page 1 of 2 (5 locations)

1

NHS Fife

Dunfermline, Fife, United Kingdom, KY12 OSU

2

Addenbrooke's Hospital

Cambridge, United Kingdom

3

NHS Lothian

Edinburgh, United Kingdom

4

Guy's and St Thomas

London, United Kingdom

Bladder EpiCheck European Haematuria Study | DecenTrialz