A study to assess how well a new urine test can identify bladder cancer in patients with blood in their pee

BC-Recon: Diagnosing Bladder Cancer - evaluating the role of a urinary biomarker test in the Reconfiguration of the haematuria clinic investigations

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN40822587

Enrollment

3200

Registered

2023-11-14

Start date

2023-10-01

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Bladder cancer Cancer

Interventions

In this proposed study (called 'BC-Recon'), we will run the GALEAS® Bladder test alongside the usual 'standard' care in haematuria clinics. We plan to recruit 3200 patients from 6 large urology units

we will request a single one-off urine sample from participants, to be donated for study purposes, as well as request the opportunity to contact them again 1 and 2 years later to find out if they were

• the proportion of flexis that could be avoided using GALEAS® Bladder in the haematuria clinic setting. If these calculations and measurements are promising, then these findings could lead to a larg

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients attending a haematuria clinic (one or two stop appointment in a urology clinic in secondary care) for experiencing haematuria and/or for the investigation of symptoms suspicious of bladder cancer (BC) 2. Minimum age of 18 years 3. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of bladder or upper tract urothelial cancer (UTUC) within the last 5 years 2. Previous entry into the study 3. Limited understanding of English (due to the lack of resource available to have translators in HCs to facilitate informed consent or provide the at-home urine sample collection kits with translated instructions)

Design outcomes

Primary

Measure	Time frame
1. Sensitivity of the GALEAS® Bladder test for Bladder Cancer will be calculated from the proportion of the patients who receive a diagnosis of bladder cancer following the haematuria clinic investigations, who test positive with GALEAS® Bladder. 2. Specificity of the GALEAS® Bladder test for Bladder Cancer will be calculated from the proportion of the patients who don’t receive a diagnosis bladder cancer following the haematuria clinic investigations, who test positive with GALEAS® Bladder.	—

Measure

Time frame

1. Sensitivity of the GALEAS® Bladder test for Bladder Cancer will be calculated from the proportion of the patients who receive a diagnosis of bladder cancer following the haematuria clinic investigations, who test positive with GALEAS® Bladder. 2. Specificity of the GALEAS® Bladder test for Bladder Cancer will be calculated from the proportion of the patients who don’t receive a diagnosis bladder cancer following the haematuria clinic investigations, who test positive with GALEAS® Bladder.

—

Secondary

Measure	Time frame
There are no secondary outcome measures.	—

Countries

England, United Kingdom

Contacts

Public ContactAnna Haire

Anna.haire@kcl.ac.uk+44 (0)7464492509

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026