BC-Recon 

Status: Open

Specialty: Bladder

Date Opened:22/01/2024

Planned Close Date: 15/01/2026 

Sponsor: University of birmingham 

Principal Investigator: Dr Omi Parikh

Study Title: BC-Recon 

Seeing blood in the urine (visible haematuria), or having blood detected in a urine sample by a GP (non-visible haematuria), is common. There are many possible reasons, such as urine infections, kidney infections, kidney stones, or an enlarged prostate; for many patients, no cause is ever found. However, importantly, in 10-12% of patients the cause of haematuria is due to bladder cancer (BC). Therefore, patients who experience haematuria are referred for further investigations at hospital. At this appointment, also known as a ‘Haematuria Clinic’ appointment, virtually all patients will have a camera inspection of their bladder (flexible cystoscopy, or a ‘flexi’) alongside other tests including scans and routine urine tests. A flexi is when a narrow flexible telescope is passed through the water pipe (urethra) into the bladder to allow the doctor or nurse to see any abnormalities that might represent BC. Flexi can be uncomfortable, embarrassing and result in complications, and because most patients undergoing flexi do not have BC, researchers have been trying to develop special urine tests that could be used to diagnose BC instead of flexi. With funding from Cancer Research UK, researchers at the University of Birmingham have developed a urine test which identifies the mutated DNA which comes from BC. This urine test has been commercialised by Cancer Research Technology (CRT) as GALEAS® Bladder and we have set up this study, called BC-Recon, to evaluate how accurate it is. We plan to recruit patients referred by their GP for further investigations in Haematuria Clinic and to ask them to donate a one-off urine sample for testing. This will enable us to evaluate the accuracy of the test for diagnosing BC, and whether some patients may not need flexi as part of the Haematuria Clinic investigations.