Bladder Cancer Clinical Trial
Official title:
Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study
This is a prospective observational study looking at urine samples from participants under
referral for a standard of care investigative cystoscopy and biopsy.
The study aims to test if the UroX™ biomarker (a measurable indicator of a biological
condition) can be detected in urine samples from participants who may later test positive
following a biopsy for bladder cancer. The study aims to assess the value of the biomarker as
a screening tool for bladder cancer.
Patients with and those without bladder cancer are required for the study.
Patients who undergo investigation for bladder cancer will have a cystoscopy and biopsy as
part of their routine care. These patients are then brought back to urology outpatient clinic
for their biopsy results within two weeks.
A UroX Biomarker Bladder Cancer Study patient information leaflet will be sent to all
patients who are booked for these investigations, explaining the study aims and the
requirements for participation.
On the day of their cystoscopy, potential participants will be approached and after signing a
study specific consent form, the urine sample will be accepted, given a study number and sent
for UroX biomarker testing.
These results will then be returned to the study team for comparison against the biopsy
histology result to assess for sensitivity and specificity.
While cystoscopy and biopsy are the current gold standard for diagnosis of bladder cancer, it
has been shown to have false-negatives of between 10-40%, due to factors such as operator
error or small areas of malignancy(15-17). The possibility of a screening/outpatient test for
bladder cancer with high positive predictive value would help with reduction or
prioritisation of further investigations and early diagnosis of disease thus potentially
allowing alternative treatment options.
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