Bladder EpiCheck - testing a urine test to help detect bladder cancer in people with blood in their urine
| ISRCTN | ISRCTN15306308 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15306308 |
| IRAS number | 353608 |
| Secondary identifying numbers | DMS No: 68096 |
- Submission date
- 30/01/2025
- Registration date
- 30/01/2025
- Last edited
- 10/04/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Blood in the urine (haematuria) can be a sign of bladder or urothelial cancer. Currently, when someone has blood in their urine, they will often need to have a camera examination of their bladder (cystoscopy) to check for cancer. The main purpose of this study is to test how well a new urine test (called Bladder EpiCheck) can detect urothelial carcinoma including bladder cancer and upper tract urothelial cancer in people who have blood in their urine. We are looking for participants who are due to have a scheduled standard camera examination of their bladder (called a cystoscopy) within 60 days of joining the study. We will ask them for one urine sample. The study will measure how accurately Bladder EpiCheck can identify both people who do have bladder cancer (measured as sensitivity) and people who don't have bladder cancer (measured as specificity), by comparing the urine test results tested with the Bladder EpiCheck to the results from the camera examination and any tissue samples taken. The study will also compare how well Bladder EpiCheck performs against another standard urine test called cytology, and will specifically look at how good it is at detecting more aggressive types of bladder cancer.
Who can participate?
People aged 45 years or older who have had blood in their urine (either visible or detected through testing) within the last 6 months and are scheduled to have a camera examination of their bladder. Participants must not have previously been diagnosed with bladder cancer, had a bladder camera examination for blood in urine in the past 2 years, or been treated for prostate or kidney cancer in the last 12 months.
What does the study involve?
Participants will be asked to provide a urine sample when they attend their scheduled hospital appointment for their bladder camera examination. This sample will be tested at a main central laboratory using Bladder EpiCheck. Neither the participant nor their doctor will be told the results of this test as it is for research purposes only. The study will compare the Bladder EpiCheck results with the results from standard hospital tests.
What are the possible benefits and risks of participating?
There are no direct benefits to participants, but the research may help improve how bladder cancer is detected in the future. There are no known risks from taking part as participants are only being asked to provide a urine sample.
Where is the study run from?
The study is being run at multiple NHS hospitals across the UK
When is the study starting and how long is it expected to run for?
December 2024 to August 2026
Who is funding the study?
Nucleix Ltd
Who is the main contact?
Jennifer Stuart, jennifer@lindushealth.com
Contact information
Public, Scientific
90 Union Street
London
SE1 0NW
United Kingdom
| Phone | +44 (0)808 1893802 |
|---|---|
| jennifer@lindushealth.com |
Principal Investigator
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
| Phone | +44 (0)1315372933 |
|---|---|
| param.mariappan@nhs.scot |
Study information
| Study design | Multicentre prospective double-blind non-interventional single-arm study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Bladder EpiCheck® for the primary detection of urothelial carcinoma in subjects presenting with haematuria: a multicentre, prospective, double-blind, non-interventional, single-arm study |
| Study hypothesis | The purpose of this study is to further validate the performance of the Bladder EpiCheck test for the detection of primary urothelial carcinoma in subjects presenting with haematuria (non-visible [micro] or visible [macro/gross]) within 6 months of enrollment as compared to standard of care cystoscopic examination and pathological confirmation (if indicated). The sensitivity and specificity of the test will be compared to the Reference Standard, based on cystoscopy and pathology if indicated. |
| Ethics approval(s) |
Approved 27/02/2025, Ethics North East - Newcastle & North Tyneside 1 (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8384; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 25/NE/0035 |
| Condition | Urothelial carcinoma |
| Intervention | Participants will be asked to attend their routine hospital appointment, and at this appointment provide a urine sample. There will be no additional hospital visits required for this research. This urine sample will be sent to a laboratory to be tested using the Bladder EpiCheck. The participant or doctor will not be told of the results. They will be compared to the usual hospital results for research purposes only. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bladder EpiCheck |
| Primary outcome measure | The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma, calculated versus the Reference Standard defined by cystoscopy, imaging, and, if indicated, pathological confirmation) in subjects presenting with haematuria (visible and/or non-visible). Measured at a single timepoint. |
| Secondary outcome measures | Measured at a single timepoint: 1. Non-inferiority of Bladder EpiCheck overall sensitivity vs cytology in the detection of primary urothelial carcinoma 2. Non-inferiority of Bladder EpiCheck specificity vs cytology in the detection of primary urothelial carcinoma 3. The sensitivity of the Bladder EpiCheck test to detect pathologically confirmed high-grade urothelial carcinoma, including HG non-muscle invasive and muscle-invasive disease |
| Overall study start date | 18/12/2024 |
| Overall study end date | 01/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Sex | Both |
| Target number of participants | 600 |
| Participant inclusion criteria | 1. Subjects aged 45 years or older 2. Subjects who are willing and able to provide written informed consent and adhere to study procedures 3. Subjects presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment 4. Subjects scheduled to undergo standard-of-care cystoscopy for urinary bladder examination within 60 days after study enrollment 5. Subjects who are able to produce at least 10 ml of voided urine |
| Participant exclusion criteria | 1. Subjects with history of urothelial cancer in the bladder and/or upper urinary tract 2. Subjects who had prior cystoscopy for haematuria within the past 2 years 3. Subjects previously enrolled in this study 4. Subjects treated for prostate cancer within the last 12 months 5. Subjects treated for kidney cancer within the last 12 months 6. Subjects with untreated urinary tract infection 7. Subjects with symptomatic urinary tract stones (e.g. flank pain) 8. Subjects on dialysis for end-stage renal failure 9. Subjects with a long-term urinary catheter 10. Pregnancy (self-reported) 11. Subjects who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway |
| Recruitment start date | 15/05/2025 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH4 2XU
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
St Thomas Street
London
SE1 9RT
United Kingdom
Sponsor information
Industry
3 Pekeris St
Rehovot
7670203
Israel
| Phone | +972 (0)8 9161616 |
|---|---|
| vered.y@nucleix.com | |
| Website | http://nucleix.com/ |
"ROR" |
https://ror.org/0584knp84 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in peer reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
10/04/2025: The following changes were made:
1. Ethics approval added.
2. The recruitment start date was changed from 01/04/2025 to 15/05/2025.
3. The recruitment end start date was changed from 10/07/2025 to 30/09/2025.
4. The study participating centres, Addenbrookes Hospital and Guys Hospital, were added.
30/01/2025: Study's existence confirmed by Nucleix Ltd.
