Adults referred for bladder cancer investigation following the detection of either visible haematuria (VH) or non-visible haematuria (NVH). Cancer
Conditions
Interventions
Design
This study is an observational real-world evaluation study conducted across seven UK NHS Urology Departments. All participants underwent standard diagnostic procedures for haematuria investigat
collection time was not recorded. The UCD contains 3.5ml preservative agent to inhibit bacterial growth and preserve DNA (final preservative:urine ratio 1:7-1:14). Samples were stored at room temperat
Sponsors
Nonacus Limited
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged =18 years 2. Patients referred for investigation following the detection of either visible haematuria (VH) or non-visible haematuria (NVH) 3. Patients with the ability to provide informed consent 4. Patients with the ability to provide a voided urine sample prior to cystoscopy
Exclusion criteria
Exclusion criteria: 1. Patients with a prior diagnosis of urothelial cancer 2. Patients with an inability to provide an adequate urine sample 3. Patients with an unwillingness or inability to undergo standard haematuria investigations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic sensitivity and specificity of GALEAS™ Bladder for detection of bladder cancer measured using a comparison of GALEAS™ Bladder assay results against flexible cystoscopy with histopathological confirmation, expressed as sensitivity, specificity, positive predictive value and negative predictive value with 95% confidence intervals calculated from 2×2 contingency tables (Wilson score method) at one timepoint, following the receipt of both GALEAS™ Bladder result and final diagnosis during the study period of October 2024 to June 2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical usefulness of GALEAS™ Bladder measured using positive and negative likelihood ratios and diagnostic odds ratio with 95% confidence intervals calculated from the final 2×2 contingency table at study data lock in June 2025 following availability of both GALEAS™ Bladder results and reference standard (cystoscopy with or without histopathology);Molecular patterns in GALEAS™ Bladder-positive urine samples measured using comparison of frequency and variant allele frequency (VAF) of cancer-associated mutations across the 23-gene panel between true-positive and discordant-positive samples by gene and mutation type at data lock in June 2025 following confirmation against cystoscopy and histopathology;Diagnostic sensitivity and negative predictive value (NPV) of GALEAS™ Bladder for detection of high-grade bladder cancer measured using sensitivity and NPV with 95% confidence intervals calculated using the Wilson score method from a 2×2 contingency table against flexible cystoscopy with histopathological confirmation at one time point, following receipt of both GALEAS™ Bladder result and histopathological grade and stage confirmation during the study period of October 2024 to June 2025;Diagnostic performance of GALEAS™ Bladder for muscle-invasive bladder cancer (MIBC) measured using Diagnostic sensitivity and negative predictive value of GALEAS™ Bladder for detection of muscle-invasive bladder cancer measured using sensitivity and negative predictive value with 95% confidence intervals calculated using the Wilson score method from a 2×2 contingency table against flexible cystoscopy and histopathological confirmation at one time point, following receipt of both GALEAS™ Bladder result and histopathological grade and stage confirmation during the study period of October 2024 to June 2025;Diagnostic performance of GALEAS™ Bladder stratified by haematuria type (visible/non-visible) recorded at or prior to clinic attendance measured using sensitivity, specificity, positive p | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLee Silcock
Outcome results
None listed