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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2019
CompletedFirst Submitted
Initial submission to the registry
June 1, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJune 4, 2019
June 1, 2019
1.4 years
June 1, 2019
June 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Participants with bladder cancer
50 participants with histologically confirmed evidence of malignancy for bladder cancer following routine cystoscopy and biopsy.
Participants without bladder cancer
50 participants with negative biopsy for bladder cancer following routine cystoscopy and biopsy.
Interventions
Urine test using novel UroX biomarker test for bladder malignancy
Eligibility Criteria
Participants under investigation for possible bladder cancer due to undergo cystoscopy and biopsy.
You may qualify if:
- Patients aged ≥ 18 years of age
- Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy
You may not qualify if:
- Patients aged \< 18 years of age
- Patients who are currently undergoing radiation therapy.
- Proposed subject has no bladder (due to surgical removal).
- Patients unable or unwilling to provide consent
- Patients currently on investigational drug trials
- Patients with Catheter in Situ
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East and North Hertfordshire NHS Trustlead
- KDx Diagnostics Inc.collaborator
Study Sites (1)
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG14AB, United Kingdom
Biospecimen
Urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikhil Vasdev
East and North Hertfordshire NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2019
First Posted
June 4, 2019
Study Start
January 21, 2019
Primary Completion
July 1, 2020
Study Completion
July 1, 2025
Last Updated
June 4, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share