Suspected bladder cancer Cancer Malignant neoplasm of bladder
Conditions
Interventions
Patient attending the clinic for their cystoscopy procedure will be asked for their permission to collect the left-over urine from this visit. The research team will use the collected sample to assess
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over the age of 18 2. Presenting with visible and non-visible haematuria within 12 weeks of the consent visit 3. Scheduled for a standard of care cystoscopy 4. Agrees to provide voided urine for trial purposes 5. Able to consent
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of bladder cancer 2. Previous history of kidney stone 3. Indwelling urethral catheter 4. Ongoing urinary tract infection 5. Not able to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance characteristics of Xpert Detection on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting bladder cancer in patients with haematuria: 1. The number of patients correctly diagnosed with bladder cancer in comparison to the Xpert bladder test (true positive) 2. Sensitivity/specificity of the new index test in comparison to histopathology. Sensitivity will use histopathology as standard. Specificity will be calculated by the ability of the Xpert bladder test to rule out false positives in a clinical setting. Measured at 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the total cost of both diagnosis (cystoscopy and cytology) strategies (with or without Xpert Bladder Cancer Detection), measured at 18 months | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactGhulam Nabi
Outcome results
None listed