A real-world evaluation of a bladder cancer biomarker pathway
| ISRCTN | ISRCTN11466534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11466534 |
| Integrated Research Application System (IRAS) | 364053 |
| Protocol serial number | R&D:5650 |
| Sponsor | North Bristol NHS Trust |
| Funders | Nonacus (formerly Informed Genomics), Somerset, Wiltshire, Avon and Gloucestershire Cancer Alliance |
- Submission date
- 06/11/2025
- Registration date
- 11/02/2026
- Last edited
- 11/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Bladder Cancer (BC) is the seventh most common cancer in Western Society, with around 10,000 new BC cases registered per year in the UK. BC is not immediately life-threatening, but up to 44% of patients with BC progress to a more serious type. This type of BC has a 27-50% 5-year survival rate. Outcomes for BC have not improved for over 25 years; therefore, it is important to research better diagnosis and treatment methods. This study looks at the tests patients have when they are sent to the hospital for possible BC. When a patient has blood in their urine, they go to the hospital where they have their urine tested and have a test called a flexible cystoscopy. A small camera on a flexible tube is used to look inside the bladder. This can be quite uncomfortable and also means the patient has to visit the hospital to have it done. A new testing kit has been made that can check for BC by looking at biomarkers (small molecules) in patients' urine. This study wants to see if it is practical and easy for patients to do a urine sample at home and send it back to the lab for testing. This study is the first step in helping researchers learn if some patients can be checked for BC using this urine test without having a flexible cystoscopy.
Who can participate?
Adult patients referred to the hospital with blood in their urine will be asked if they want to take part.
What does the study involve?
Participants will have all their usual tests and appointments, but also be provided a urine sample from home and post it (free) back to the lab. The urine kit will be sent to the participant's home and will include instructions on when and how to collect the urine sample. The samples will be given unique ID numbers so lab researchers will not know the names of the participants. The research team will also check the patients' notes to see the outcome of the hospital tests.
What are the possible benefits and risks of participating?
Benefits: Participants will not experience any direct benefit from participating in the study. However, this study hopes to provide information to guide a better and less invasive diagnostic pathway for suspected bladder cancer patients in the future.
Risks: This study has minimal participant burden and no significant risks. Participants may face barriers in providing and returning a urine sample due to access to post box or mobility difficulties.
Where is the study run from?
North Bristol NHS Trust (Southmead Hospital), UK
When is the study starting and how long is it expected to run for?
The study is expected to start 01/12/2025 with recruitment starting 01/02/2026 and the study ending 31/06/2027.
Who is funding the study?
1. Nonacus (formerly Informed Genomics), UK
2. NHS Somerset, Wiltshire, Avon and Gloucestershire Cancer Alliance, UK
Who is the main contact?
Prof Jonathan Aning, jonathan.aning@nbt.nhs.uk
Contact information
Public, Scientific, Principal investigator
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 0117 414 9330 |
|---|---|
| jonathan.aning@nbt.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre cohort observational study using sample analysis and questionnaires |
| Secondary study design | Cohort study |
| Scientific title | Urinary biomarker real world evaluation- bladder cancer pathway |
| Study acronym | ARMADA- BCP |
| Study objectives | This study aims to find out if GALEAS® Bladder testing kits could improve the real-world pathway for patients referred to hospital with blood in their urine. This study will see if it practical and easy for patients to provide a urine sample at home and send it off for testing. Hopefully, this might highlight if the test could be used to reduce the number of unnecessary cystoscopies undertaken on patients in the future. This study also aims to asses the diagnostic performance of the GALEAS® Bladder testing kits in the real-world. We are also looking at the acceptability of the test in the real world. |
| Ethics approval(s) |
Approved 24/12/2025, East of England - Cambridge South Research Ethics Committee (Equinox House, City Link, Nottningham, NG2 4LA, United Kingdom; -; Cambridgesouth.rec@hra.nhs.uk), ref: 25/EE/0280 |
| Health condition(s) or problem(s) studied | Haematuria/ suspected bladder cancer |
| Intervention | Urine samples will undergo urinary biomarker analysis. Samples returned to Nonacus Clinical Services will undergo DNA analysis using the following methodology. Sequencing reads generated via Illumina technology are aligned to the human reference genome (hg19) using BWA. Unique Molecular Identifiers (UMIs), extracted from the i7 index reads, are used to annotate each read on a per-original-molecule basis. A proprietary bioinformatics pipeline, based on widely used open-source tools, is then applied. Consensus reads are generated from a minimum of three reads sharing the same UMI and identical genomic start and stop positions. Variant calling is performed using bamreadcount to extract reference and non-reference read depths. Biomarker analysis results will be classes as either positive, negative or inconclusive. Data will be also be collected about number and quality of samples returned. |
| Intervention type | Genetic |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
Patient acceptability of home urine testing (TFA) and of the GALEAS test will be assessed through the following secondary outcome variables measured using study data at one time point, unless stated: |
| Completion date | 01/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 2378 |
| Key inclusion criteria | 1. Patients referred for the investigation of symptoms suspicious of bladder cancer (BC) 2. Minimum age of 18 years 3. Able to provide verbal informed consent |
| Key exclusion criteria | 1. Previous diagnosis of bladder or upper tract urothelial cancer (UTUC) in the last 5 years 2. Previous entry into the study 3. Must not have a long-term catheter or urostomy 4. Limited understanding of English (due to the lack of resources available to have translators in clinics to facilitate informed consent) |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 01/06/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Bath
BA1 3NG
England
Sandford Road
Cheltenham
GL53 7AN
England
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
England
Marlborough Road
Swindon
SN3 6BB
England
160 AZTEC WEST
BRISTOL
BS32 4TU
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated will be published as a supplement to the results publication. |
Editorial Notes
12/01/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).
