European validation of Bladder EpiCheck for haematuria
Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
This project will see if the Bladder EpiCheck urine methylation test can detect urothelial cancer in people aged 45 and older who have visible or non-visible blood in their urine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Nucleix Ltd. Industry-sponsored |
| Locations | 5 sites (Dunfermline, Fife and 4 other locations) |
| Trial ID | NCT06818136 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 45 or older with visible or non-visible haematuria who can provide at least 10 mL of voided urine and are scheduled for standard-of-care cystoscopy within 60 days are the ideal candidates.
Not a fit: People with prior urothelial cancer, recent cystoscopy for haematuria, untreated urinary tract infection, recent treatment for prostate or kidney cancer, symptomatic urinary stones, or inability to provide a urine sample are unlikely to benefit from this validation.
Why it matters
Potential benefit: If successful, the test could help detect urothelial cancers from urine and reduce the need for invasive cystoscopy in some patients.
How similar studies have performed: Prior studies of Bladder EpiCheck and other urinary methylation assays have shown promising sensitivity and specificity for detecting bladder cancer, but results have varied and further validation in haematuria populations is ongoing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dunfermline, Fife and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.