Bladder cancer Cancer Malignant neoplasm of bladder
Conditions
Interventions
Patients newly presenting with haematuria will have urine samples collected. These samples will be used for URO17 and cytology tests. They will also have standard investigations including cystoscopy
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent 2. Attending Rapid Access Haematuria Clinic (RAHC) for further investigation for suspected bladder cancer 3. Patients aged >18 years with either visible haematuria or with symptomatic LUTS associated with non-visible haematuria
Exclusion criteria
Exclusion criteria: 1. Participant unable to give informed consent 2. Previous history of urinary tract malignancy 3. Previous history of pelvic radiotherapy 4. Active urine infection 5. Be currently taking investigational drugs or actively participating in a treatment trial for any condition 6. Be an employee of the study site or the sponsor 7. Have a medical condition or serious intercurrent illness, or other circumstance that, in the Investigator’s judgment, could jeopardize the candidate’s safety as a study subject, or that could interfere with study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder cancer diagnosis measured by Urinary Biomarker URO17 at baseline and review of patient notes following completion of investigations (within 60 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient acceptability measured using VAS questionnaire at baseline and following cystoscopy procedure within 1 hour 2. Home collection kit accuracy measured by repeat URO17 urinary biomarker test at baseline 3. Cost effectiveness measured by costing of procedures during clinic appointment and review of the literature 4. Bladder cancer diagnosis measured by Urine Cytology and review of patient notes at baseline and review of patient notes following completion of investigations (within 60 days) | — |
Countries
United Kingdom
Contacts
Public ContactJulie Mort
Outcome results
None listed