UroX Biomarker Bladder Cancer Study

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    100
  • sponsor
    East and North Hertfordshire NHS Trust
Updated on 9 February 2022
cancer
bladder cancer
cystoscopy
bladder tumor
Accepts healthy volunteers

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.

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.

Details
Condition Bladder Cancer
Treatment UroX bladder cancer biomarker test
Clinical Study IdentifierNCT03973307
SponsorEast and North Hertfordshire NHS Trust
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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