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
NCT number | NCT03973307 |
Other study ID # | RD2018-68 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 21, 2019 |
Est. completion date | July 1, 2025 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | East and North Hertfordshire NHS Trust | Stevenage | Hertfordshire |
Lead Sponsor | Collaborator |
---|---|
East and North Hertfordshire NHS Trust | KDx Diagnostics Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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