Testing a new urine biomarker for bladder cancer detection
Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study
This study is testing a new urine test called UroX to see if it can help detect bladder cancer in patients who are already having tests for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Stevenage, Hertfordshire) |
| Trial ID | NCT03973307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the UroX biomarker in urine samples from patients undergoing standard investigative cystoscopy and biopsy for bladder cancer. Participants will provide urine samples on the day of their cystoscopy, which will be tested for the UroX biomarker. The results will be compared to biopsy histology to assess the biomarker's sensitivity and specificity in detecting bladder cancer. The study includes both patients with and without bladder cancer to determine the biomarker's effectiveness as a screening tool.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are under investigation for bladder cancer and scheduled for a biopsy.
Not a fit: Patients under 18, those currently undergoing radiation therapy, or individuals who have had their bladder surgically removed will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive screening method for bladder cancer, improving early diagnosis and treatment options.
How similar studies have performed: While the approach of using biomarkers for cancer detection is established, the specific UroX biomarker's effectiveness in bladder cancer detection is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stevenage, Hertfordshire
- East and North Hertfordshire NHS Trust — Stevenage, Hertfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nikhil Vasdev — East and North Hertfordshire NHS Trust
- Study coordinator: Nikhil Vasdev
- Email: nikhil.vasdev@nhs.net
- Phone: 01438 28 4042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.