UroX Biomarker Bladder Cancer Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: UroX bladder cancer biomarker test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 18 years of age Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy Exclusion Criteria: Patients aged < 18 years of age Patients who are currently undergoing radiation therapy. Proposed subject has no bladder (due to surgical removal). No cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results) Patients unable or unwilling to provide consent Patients currently on investigational drug trials Patients with Catheter in Situ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with bladder cancer<br>50 participants with histologically confirmed evidence of malignancy for bladder cancer following routine cystoscopy and biopsy. | Diagnostic Test: UroX bladder cancer biomarker test<br>* Urine test using novel UroX biomarker test for bladder malignancy<br>|
| Participants without bladder cancer<br>50 participants with negative biopsy for bladder cancer following routine cystoscopy and biopsy. | Diagnostic Test: UroX bladder cancer biomarker test<br>* Urine test using novel UroX biomarker test for bladder malignancy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the diagnostic accuracy of the UroX™ biomarker urine test | UroX™ urine biomarker staining result compared with standard of care biopsy result | 1 day (single visit/test) |