NCT06818136 Bladder EpiCheck European Haematuria Study
| NCT ID | NCT06818136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nucleix Ltd. |
| Condition | Hematuria |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-06-20 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS
PRINCIPAL INVESTIGATOR
Western General Hospital, Edinburgh
Frequently Asked Questions
Who can join the NCT06818136 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Hematuria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06818136 currently recruiting?
Yes, NCT06818136 is actively recruiting participants. Contact the research team at vered.y@nucleix.com for enrollment information.
Where is the NCT06818136 trial being conducted?
This trial is being conducted at Dunfermline, United Kingdom, Cambridge, United Kingdom, Edinburgh, United Kingdom, London, United Kingdom and 1 additional location.
Who is sponsoring the NCT06818136 clinical trial?
NCT06818136 is sponsored by Nucleix Ltd.. The principal investigator is Paramananthan Mariappan, MB BS PhD FRCS(Urol) FEBU FRCS at Western General Hospital, Edinburgh. The trial plans to enroll 800 participants.