Bladder EpiCheck European Haematuria study
Research type
Research Study
Full title
Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting with Haematuria A Multicenter, Prospective, Double-Blind, Non-interventional, Single arm Study
IRAS ID
353608
Contact name
Paramananthan Mairappan
Contact email
Sponsor organisation
Nucleix Ltd
ISRCTN Number
ISRCTN15306308
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
This research aims to further evaluate a CE marked device, a urine test called Bladder EpiCheck that could help detect urothelial carcinoma (including bladder cancer and upper tract urothelial carcinoma) in a less invasive way. Bladder cancer is the 5th most common cancer in Europe and the UK, affecting thousands of people each year.
Currently, doctors detect bladder cancer using a procedure called cystoscopy, which involves inserting a small camera into the bladder. While effective, this can be uncomfortable for patients and create substantial burden on the health system.
Our study will involve patients who have confirmed blood in their urine and who are already scheduled for haematuria workup, attending for a cystoscopy. Participants will be asked to simply provide a urine sample during their regular hospital visit prior to their cystoscopy. This urine sample will be sent to a central laboratory and tested using the Bladder EpiCheck. We will compare these results with their standard cystoscopy findings and if performed, pathology to determine how accurate the urine test is.
Importantly, participants won't need any extra hospital visits beyond their routine care and their standard clinical care will not change. The investigator and the participant will not be told of the EpiCheck result which will be used for research purposes only.
The findings could help urothelial carcinoma including bladder cancer and upper tract urothelial carcinoma detection more timely and efficient by identifying patients who should be referred to urgent haematuria workup, and more comfortable for patients in the future, while maintaining high diagnostic standards.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
25/NE/0035
Date of REC Opinion
27 Feb 2025
REC opinion
Further Information Favourable Opinion