European validation of Bladder EpiCheck for haematuria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls adults aged 45 or older who present with visible or non-visible haematuria and are scheduled for cystoscopy. Participants provide a voided urine sample that is tested with the Bladder EpiCheck methylation assay, and results are compared against cystoscopy findings and pathology when available. Clinical data from the standard haematuria work-up are collected without changing routine care. The aim is to validate the sensitivity and specificity of Bladder EpiCheck for primary detection of urothelial carcinoma across several UK centres.

Why it matters

Who can join: the full rules

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

Where it's running

• NHS Fife
  Dunfermline, Fife, United Kingdom Recruiting
• Addenbrooke's Hospital
  Cambridge, United Kingdom Recruiting
• NHS Lothian
  Edinburgh, United Kingdom Recruiting
• Guy's and St Thomas
  London, United Kingdom Recruiting
• Frimley
  Surrey Quays, United Kingdom Recruiting

Study contacts

• Principal investigator: Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS — Western General Hospital, Edinburgh
• Study coordinator: Vered Yayon
• Email: vered.y@nucleix.com
• Phone: +972-8-9161616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.