Bladder cancer detection using a non-invasive urinary biomarker URO17™ in patients with suspected bladder cancer

Not Applicable

Completed

• Conditions: Bladder cancer; Cancer; Malignant neoplasm of bladder

• Registration Number: ISRCTN66923582
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-18
• Study Completion: 2023-11-30
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bladder cancer diagnosis measured by Urinary Biomarker URO17 at baseline and review of patient notes following completion of investigations (within 60 days)

Secondary Outcome Measures

Name	Time	Method
1. Patient acceptability measured using VAS questionnaire at baseline and following cystoscopy procedure within 1 hour<br>2. Home collection kit accuracy measured by repeat URO17 urinary biomarker test at baseline<br>3. Cost effectiveness measured by costing of procedures during clinic appointment and review of the literature<br>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)