UroX Biomarker Bladder Cancer Study

June 1, 2019 updated by: East and North Hertfordshire NHS Trust

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG14AB
        • Recruiting
        • East and North Hertfordshire NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 1 day (single visit/test)
UroX™ urine biomarker staining result compared with standard of care biopsy result
1 day (single visit/test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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