Bladder EpiCheck European Haematuria Study

Launched by NUCLEIX LTD. · Feb 4, 2025

Keywords

ClinConnect Summary

The Bladder EpiCheck European Haematuria Study is a clinical trial aimed at improving the way we detect a type of bladder cancer known as urothelial carcinoma, especially in people aged 45 and older who have blood in their urine (a condition called hematuria). This study will compare a new urine test called Bladder EpiCheck with the standard method of checking the bladder using a procedure called cystoscopy, where a thin tube with a camera is inserted into the bladder. Participants will need to provide a urine sample and may have additional tests as part of their usual medical care.

To be eligible for this study, participants must be 45 years or older, have had visible or invisible blood in their urine within the last six months, and be scheduled for a cystoscopy in the next two months. They must also be able to provide a urine sample of at least 10 milliliters (about two teaspoons). However, those with a history of bladder or kidney cancer, recent cystoscopy, or certain other medical conditions will not be able to participate. The trial is currently not recruiting participants, but it will help to determine if the Bladder EpiCheck test can effectively detect bladder cancer earlier and more accurately.

Gender

ALL

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