To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.

The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC early is crucial to increase the chances of a cure. Cystoscopy, which is currently the standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive procedure but, while several potential markers in urine have been studied with the goal of replacing cystoscopy, no urinary marker alone or in combination with others has shown sufficient accuracy.

In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine samples collected from patients referred to the haematuria clinic with visible or microscopic haematuria. These values will be linked to the subsequent diagnosis of each patient, and used to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.

Inclusion Criteria:

• Capable of giving written informed consent
• Age ≥18 years
• Referral to haematuria clinic (gross or microscopic haematuria)

Exclusion Criteria:

• Inability to provide written informed consent
• Previous radiotherapy to the bladder (e.g. prostate cancer)
• Active urinary tract infection (Patients may be re-approached at later opportunity when urinary infection is cleared and haematuria persists)
• Current or planned treatment with neoadjuvant chemotherapy or radiotherapy
• Other known malignant condition, either active or in complete remission ≤5 years
• HIV, hepatitis C, or any other known communicable disease

Study participants will be recruited from all patients referred to the haematuria clinic due to gross (visible) haematuria or findings on routine urinalysis suggestive of microscopic haematuria. These patients will be undergoing routine investigative cystoscopy on suspicion of urothelial cancer.