A real-world evaluation of a bladder cancer biomarker pathway

Urinary biomarker real world evaluation- bladder cancer pathway

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11466534

Enrollment

2378

Registered

2026-02-11

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematuria/ suspected bladder cancer Cancer

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Secondary

Measure	Time frame
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: 1. Feasibility of postal return system (return rate of GALEAS® Bladder kits) 2. Timeliness of receipt of GALEUS® Bladder result to inform clinical care 3. Sensitivity and specificity of GALEAS® Bladder vs. standard HC diagnostics measured using flexi ± cytology/imaging and, where appropriate, cystoscopy and bladder biopsy 4. Proportion of positive GALEAS® results among patients with ultimately negative HC investigations 5. Modelling of reduction in flexis if GALEAS® Bladder is used as a triage tool 6. Environmental/lifecycle impact modelling of alternate pathways, including those involving reduced procedures 7. Anticipated facilitators and barriers to implementation from health care professional perspectives measured using the Consolidated Framework for Implementation Research (CFIR)] at the end of study recruitment at each participating centre	—

Measure

Time frame

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: 1. Feasibility of postal return system (return rate of GALEAS® Bladder kits) 2. Timeliness of receipt of GALEUS® Bladder result to inform clinical care 3. Sensitivity and specificity of GALEAS® Bladder vs. standard HC diagnostics measured using flexi ± cytology/imaging and, where appropriate, cystoscopy and bladder biopsy 4. Proportion of positive GALEAS® results among patients with ultimately negative HC investigations 5. Modelling of reduction in flexis if GALEAS® Bladder is used as a triage tool 6. Environmental/lifecycle impact modelling of alternate pathways, including those involving reduced procedures 7. Anticipated facilitators and barriers to implementation from health care professional perspectives measured using the Consolidated Framework for Implementation Research (CFIR)] at the end of study recruitment at each participating centre

—

Countries

England, United Kingdom

Contacts

Public ContactJonathan Aning

jonathan.aning@nbt.nhs.uk+44 0117 414 9330

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026