Urinary Biomarker URO17 Study
Research type
Research Study
Full title
Bladder cancer detection using a non-invasive urinary biomarker URO17™ in patients with suspected bladder cancer.
IRAS ID
298341
Contact name
Ian Weeks
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
Bladder cancer is the second most common cancer of the urinary system. The most common symptom of bladder cancer is haematuria, blood in the urine. Patients being investigated for haematuria may undergo radiology scans and an examination of the bladder using a camera which is called cystoscopy. Cystoscopy is an invasive, sometimes painful and expensive procedure. A high proportion of bladder cancers recur after treatment therefore radiology and cystoscopy are routinely repeated. These tests are often carried out alongside non-invasive tests such as Urine Cytology in which urine samples are looked at under microscope to try and identify cancer cells. However urine cytology is not very accurate therefore there is a need for a new non-invasive method of cancer detection.
The URO17™ Bladder Cancer Test has been shown in previous studies to be very effective at detecting bladder cancer cells in urine samples. This study aims to test this in a larger group of patients. This will be done by applying the test to the urine samples of patients who are having standard investigations for haematuria and then comparing the results.
The study will recruit 500 patients attending the Urology Clinic at the University Hospital of Wales Cardiff for haematuria investigations. The patients will be asked to give consent to provide a urine sample and for their clinical data to be used in the study.
A smaller group of patients will be asked to complete a questionnaire which would aim to find out if patients would accept having a urine sample test instead of a cystoscopy to investigate their bladder.
There will also be a small evaluation project to test the performance of a potential home urine collection system.REC name
London - Queen Square Research Ethics Committee
REC reference
21/PR/0745
Date of REC Opinion
10 Jun 2021
REC opinion
Further Information Favourable Opinion