UroX Biomarker Bladder Cancer Study

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Diagnostic test: UroX bladder cancer biomarker test

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Nikhil Vasdev; Phone Number: 01438 28 4042; Email: nikhil.vasdev@nhs.net
• Study Contact Backup: Name: Alex Hampson; Phone Number: 01438 28 4379; Email: alexander.hampson@nhs.net

Study Locations

• United Kingdom
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG14AB
      • Recruiting
      • East and North Hertfordshire NHS Trust
      • Contact: Nikhil Vasdev; Phone Number: 01438 28 4042; Email: nikhil.vasdev@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants under investigation for possible bladder cancer due to undergo cystoscopy and biopsy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with bladder cancer; 50 participants with histologically confirmed evidence of malignancy for bladder cancer following routine cystoscopy and biopsy.	Diagnostic test: UroX bladder cancer biomarker test; Urine test using novel UroX biomarker test for bladder malignancy
Participants without bladder cancer; 50 participants with negative biopsy for bladder cancer following routine cystoscopy and biopsy.	Diagnostic test: UroX bladder cancer biomarker test; Urine test using novel UroX biomarker test for bladder malignancy

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)

Collaborators and Investigators

• Sponsor: East and North Hertfordshire NHS Trust
• Collaborators: KDx Diagnostics Inc.
• Investigators: Principal Investigator: Nikhil Vasdev, East and North Hertfordshire NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2025

Study Registration Dates

• First Submitted: June 1, 2019
• First Submitted That Met QC Criteria: June 1, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 1, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: RD2018-68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No