Real-world evaluation of the GALEAS™ Bladder biomarker for bladder cancer detection
| ISRCTN | ISRCTN15215837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15215837 |
| Sponsor | Nonacus Limited |
| Funder | Nonacus Limited |
- Submission date
- 02/06/2026
- Registration date
- 24/06/2026
- Last edited
- 24/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Bladder cancer is one of the most common cancers in the UK, with around 10,000–18,000 new cases diagnosed each year. While it is not always immediately life-threatening, up to 44% of cases can progress to a more serious form of the disease, which has a 5-year survival rate of 27–50%. Outcomes for bladder cancer have not significantly improved for over 25 years, highlighting the need for better ways to diagnose and manage the disease.
A common warning sign of bladder cancer is blood in the urine (haematuria). However, most people referred to hospital with haematuria do not have bladder cancer. At present, these patients are usually investigated with a flexible cystoscopy, where a thin camera is used to look inside the bladder. This test is effective but can be uncomfortable and requires a hospital visit, placing pressure on NHS services.
New tests are being developed that can detect bladder cancer using urine samples. These tests look for biomarkers, such as small changes in genetic material (DNA), that are associated with cancer. The GALEAS™ Bladder test is one such test. This study aims to assess how well the GALEAS™ Bladder urine test detects bladder cancer in patients referred with haematuria. This is an important early step in understanding whether some patients could, in the future, be assessed using a simple urine test instead of, or before, undergoing cystoscopy.
Who can participate?
Adults aged 18 years and over who have been referred to an NHS Urology Department for urgent investigation of haematuria (blood in the urine), either visible to the naked eye or detected on urine testing and who are able to provide a urine sample and undergo standard haematuria investigations including flexible cystoscopy.
What does the study involve?
Participants are asked to provide a urine sample before their cystoscopy appointment, using a special urine collection device that can be used at home. The device contains a preservative to keep the urine sample stable during transport to the laboratory. Participants then attend their normal haematuria clinic appointment and undergo their standard NHS investigations, including flexible cystoscopy, exactly as they would if they were not in the study. Where cystoscopy identifies an abnormality, standard biopsy and tissue analysis takes place as normal.
The urine sample is sent to the Nonacus Clinical Services laboratory in Birmingham, where it is tested using the GALEAS™ Bladder assay. This test analyses DNA in the urine to look for genetic changes associated with bladder cancer. The GALEAS™ Bladder result is then compared with the outcome of the cystoscopy and any tissue analysis to assess how accurately the urine test detects bladder cancer.
Participation does not change the standard care or investigations that patients receive. No additional hospital visits are required beyond those already planned as part of routine haematuria investigation.
What are the possible benefits and risks of participating?
Participants do not receive a direct clinical benefit from their GALEAS™ Bladder result as part of this study, as the test result is not used to guide their clinical care at this stage. However, participation contributes to research that may benefit future patients by helping to develop a faster and less invasive way of investigating haematuria and diagnosing bladder cancer earlier.
There are no direct risks to participants from taking part in this study. Providing a urine sample at home carries no medical risk. All standard clinical investigations proceed exactly as they would outside of the study, so participants are not exposed to any additional procedures or risks as a result of participation.
Where is the study run from?
The study is run across seven NHS Urology Departments in the United Kingdom:
University Hospitals of Leicester NHS Trust
Department of Urology, Royal Berkshire Hospital
Department of Urology, Manchester University NHS Foundation Trust
Kingston and Richmond NHS Foundation Trust
Dorset County Hospital NHS Foundation Trust
Department of Urology, Western General Hospital, Edinburgh, EH4 2XU
Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh, EH4 2XU
Leeds Teaching Hospitals NHS Trust
Laboratory analysis of all urine samples is carried out at Nonacus Clinical Services, Birmingham, an ISO 15189 UKAS-accredited diagnostic laboratory.
When is the study starting and how long is it expected to run for?
The study started in October 2024 and recruitment was completed in August 2025. The total duration of the study from first patient enrolled to completion of data collection was approximately nine months.
Who is funding the study?
Nonacus Ltd, Birmingham, UK.
Who is the main contact?
Lee Silcock, Co-Founder Nonacus Ltd, lee.silcock@nonacus.com
Contact information
Public, Scientific
Unit 5, Quinton Business Park, 11 Ridgeway, Quinton
Birmingham
B32 1AF
United Kingdom
 ORCID ID |
0009-0000-2806-1778 |
|---|---|
| Phone | +44 07793316851 |
| lee.silcock@nonacus.com |
Scientific
Bladder Cancer Research Centre, Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 01214147870 |
|---|---|
| r.t.bryan@bham.ac.uk |
Scientific
Bladder Cancer Research Centre
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 01214147870 |
|---|---|
| d.g.ward@bham.ac.uk |
Principal investigator
Leicester General Hospital
Gwendolen Rd
Leicester
LE5 4PW
United Kingdom
| Phone | +44 0300 303 1573 |
|---|---|
| jayne.moore@nhs.net |
Principal investigator
Royal Berkshire Hospital
3-5 Craven Rd
Reading
RG1 5LF
United Kingdom
| Phone | +44 0118 322 5111 |
|---|---|
| christopher.blick@royalberkshire.nhs.uk |
Principal investigator
Manchester Royal Infirmary
Oxford Rd
Manchester
M13 9WL
United Kingdom
| Phone | +44 0161 276 1234 |
|---|---|
| amar.mohee@mft.nhs.uk |
Principal investigator
Kingston Hospital
Galsworthy Rd
Kingston upon Thames
KT2 7QB
United Kingdom
| Phone | +44 020 8546 7711 |
|---|---|
| nadine.coull@nhs.net |
Principal investigator
Dorset County Hospital
Williams Ave
Dorchester
DT1 2JY
United Kingdom
| Phone | +44 01305 251150 |
|---|---|
| richard.tippett@dchft.nhs.uk |
Principal investigator
Western General Hospital
Crewe Rd S
Edinburgh
EH4 2XU
United Kingdom
| Phone | +44 0131 537 1000 |
|---|---|
| alexander.laird@nhs.scot |
Principal investigator
St James's University Hospital
Beckett St
Harehills
Leeds
LS9 7TF
United Kingdom
| Phone | +44 0113 243 3144 |
|---|---|
| u.mufti@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Real-world multicentre evaluation of GALEAS™ Bladder for the detection of bladder cancer in UK NHS haematuria clinics |
| Study objectives | To assess the diagnostic performance and clinical utility of GALEAS™ Bladder as a molecular triage tool in real-world haematuria investigation pathways. |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Adults referred for bladder cancer investigation following the detection of either visible haematuria (VH) or non-visible haematuria (NVH). |
| Methodology | Design This study is an observational real-world evaluation study conducted across seven UK NHS Urology Departments. All participants underwent standard diagnostic procedures for haematuria investigation, including flexible cystoscopy for direct bladder visualisation, imaging to assess the upper urinary tract, and histological confirmation where indicated. Study Population Eligibility criteria included adults aged ≥18 years referred for investigation following the detection of either visible haematuria (VH) or non-visible haematuria (NVH), with the ability to provide informed consent and a voided urine sample prior to cystoscopy. Exclusion criteria comprised a prior diagnosis of urothelial cancer, inability to provide an adequate urine sample, or unwillingness or inability to undergo standard haematuria investigations. Sample processing with GALEAS™ Bladder All referrals, sample receipt, processing, and reporting were conducted at Nonacus Clinical Services (NCS), an ISO 15189 UKAS-accredited laboratory. Urine samples (≥25 ml) were collected primarily at home using the GALEAS™ Urine Collection Device (UCD); collection time was not recorded. The UCD contains 3.5ml preservative agent to inhibit bacterial growth and preserve DNA (final preservative:urine ratio 1:7-1:14). Samples were stored at room temperature for ≤28 days prior to processing. UCD content was centrifuged at 1500g for 10 minutes to isolate a pellet from which genomic DNA was extracted using the GALEAS™ Bead Xtract: Urine gDNA 96 kit. DNA quantification was performed using Qubit (Thermo, USA). DNA libraries were prepared using the GALEAS™ Bladder NGS kit (Nonacus Ltd, UK), targeting a panel of >450 single nucleotide variants across 23 genes. Sequencing was performed on an Illumina NextSeq 2000 (Illumina, USA) and FASTQ files processed using the proprietary GALEAS™ Bladder Software pipeline (Supplemental Methods). Statistical Analysis This study aimed to recruit 1,200 patients, based on an estimated BC prevalence of 10.5%. Accounting for an anticipated combined 10% participant dropout rate and patient non-compliance. This sample size was expected to yield approximately 113 BC positive and 967 BC-negative evaluable cases. Diagnostic performance metrics were calculated from 2×2 contingency tables. Likelihood ratios were computed as LR+ = sensitivity/(1-specificity) and LR-= (1-sensitivity)/specificity, with 95% confidence intervals via the Wilson score method. The diagnostic odds ratio (DOR) was calculated as (TP×TN)/(DP×FN), representing the odds of a positive test result in patients with cancer relative to those without. |
| Intervention type | Genetic |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 22/08/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1200 |
| Total final enrolment | 964 |
| Key inclusion criteria | 1. Adult patients aged ≥18 years 2. Patients referred for investigation following the detection of either visible haematuria (VH) or non-visible haematuria (NVH) 3. Patients with the ability to provide informed consent 4. Patients with the ability to provide a voided urine sample prior to cystoscopy |
| Key exclusion criteria | 1. Patients with a prior diagnosis of urothelial cancer 2. Patients with an inability to provide an adequate urine sample 3. Patients with an unwillingness or inability to undergo standard haematuria investigations |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
London Road
Reading
RG1 5AN
England
Leicester
LE5 4PW
England
2-4 Waterloo Place
Edinburgh
EH1 3EG
Scotland
Galsworthy Road
Kingston upon Thames
KT2 7QB
England
Beckett Street
Leeds
LS9 7TF
England
Williams Avenue
Dorchester
DT1 2JY
England
Oxford Road
Manchester
M13 9WL
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
24/06/2026: Study’s existence confirmed by the University Hospitals of Leicester Trust, UK.
