Bladder cancer detection using a non-invasive urinary biomarker URO17™ in patients with suspected bladder cancer
| ISRCTN | ISRCTN66923582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66923582 |
| IRAS number | 298341 |
| Secondary identifying numbers | IRAS 298341, SPON 1846-21 |
- Submission date
- 27/05/2021
- Registration date
- 18/06/2021
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Bladder cancer is the second most common cancer of the urinary system. The most common symptom of bladder cancer is haematuria, blood in the urine. Patients being investigated for haematuria may undergo radiology scans and an examination of the bladder using a camera which is called cystoscopy. Cystoscopy is an invasive, sometimes painful and expensive procedure. A high proportion of bladder cancers recur after treatment therefore radiology and cystoscopy are routinely repeated. These tests are often carried out alongside non-invasive tests such as Urine Cytology in which urine samples are looked at under microscope to try and identify cancer cells. However urine cytology is not very accurate therefore there is a need for a new non-invasive method of cancer detection.
The URO17™ Bladder Cancer Test has been shown in previous studies to be very effective at detecting bladder cancer cells in urine samples. This study aims to test this in a larger group of patients. This will be done by applying the test to the urine samples of patients who are having standard investigations for haematuria and then comparing the results.
Who can participate?
The study will recruit 500 patients attending the Urology Clinic at the University Hospital of Wales Cardiff for haematuria investigations.
What does the study involve?
The patients will be asked to give consent to provide a urine sample and for their clinical data to be used in the study.
A smaller group of patients will be asked to complete a questionnaire which would aim to find out if patients would accept having a urine sample test instead of a cystoscopy to investigate their bladder.
There will also be a small evaluation project to test the performance of a potential home urine collection system.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University of Cardiff (UK)
When is the study starting and how long is it expected to run for?
January 2021 to November 2023
Who is funding the study?
Accelerate programme (co-funded by the Welsh European Funding Office, European Regional Development Fund and Welsh Government’s Health and Social Services Group) (UK)
Who is the main contact?
Julie Mort, Juliet.mort@wales.nhs.uk
Contact information
Public
Cardiff and Vale University Health Board
Urology Research Office
University Hospital of Wales
Cardiff
CF14 4 XW
United Kingdom
| Phone | +44 (0)2921 844146 |
|---|---|
| juliet.mort@wales.nhs.uk |
Scientific
Clinical Innovation Hub
Room GTB2 40
Main Building Heath Park Campus
Cardiff University
Cardiff
CF14 4XN
United Kingdom
| Phone | +44 (0)29 20748288 |
|---|---|
| morrisc10@cardiff.ac.uk |
Study information
| Study design | Single centre prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN66923582_PIS_v.1.1_14Apr21.pdf |
| Scientific title | Urinary Biomarker URO17 Study |
| Study objectives | To assess the ability of a urinary biomarker, URO17 to discriminate between bladder cancer and non-bladder cancer in patients presenting with haematuria |
| Ethics approval(s) | Approved 10/06/2021, London - Queen Square Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8061; queensquare.rec@hra.nhs.uk), ref: 21/PR/0745 |
| Health condition(s) or problem(s) studied | Bladder cancer |
| Intervention | 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. Details of their diagnosis will be recorded. There will also be a small evaluation project in approximately 100 patients to investigate the performance of an upstream home urine collection system to evaluate performance and compatibility with the URO17 test. A subset of patients (250 patients) will be asked to complete a questionnaire prior to, and following flexible cystoscopy, to determine the acceptability of urinary biomarkers as a replacement for flexible cystoscopy. |
| Intervention type | Other |
| Primary outcome measure | 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 | 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) |
| Overall study start date | 04/01/2021 |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/07/2021 |
| Date of final enrolment | 12/10/2022 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Heath Park
Cardiff
CF14 4 XW
United Kingdom
Sponsor information
University/education
Main Building Heath Park Campus
Cardiff
CF14 4XN
Wales
United Kingdom
| Phone | +44 (0)2920879130 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | https://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publication and dissemination plan Once the experiment and the data analysis is completed, the results will be submitted for publication in peer-reviewed journals to disseminate the findings more widely subject to a review of confidential information. The results may also contribute to scientific posters and presentations at conferences. The aim will be to effectively communicate the information to clinicians working in this area to get engagement with the novel technology. Communication of the results to relevant patient groups may also be appropriate. Use of the information in this way will only be done with consultation with all participating collaborators on the project. Where appropriate and with the permission of key collaborators, external dissemination could also include press releases, journal articles, conference presentations, reports, news items on websites etc. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 14/04/2021 | 18/06/2021 | No | Yes | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN66923582_PIS_v.1.1_14Apr21.pdf
- Uploaded 18/06/2021
Editorial Notes
10/06/2025: The intention to publish date was changed from 30/11/2024 to 01/05/2026.
04/12/2023: Contact details updated.
22/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2022 to 12/10/2022.
2. The overall end date was changed from 30/11/2022 to 30/11/2023.
3. The intention to publish date was changed from 30/11/2023 to 30/11/2024.
4. The plain English summary was updated to reflect these changes.
30/03/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/03/2022 to 30/11/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/06/2022 to 30/11/2023.
3. The total final enrolment number has been added.
13/07/2021: The recruitment start date was changed from 01/07/2021 to 07/07/2021.
18/06/2021: The participant information sheet has been uploaded.
04/06/2021: Trial's existence confirmed by Accelerate programme.
