Detecting Transitional Cell Carcinoma From Haematuria
Detecting Transitional Cell Carcinoma From Haematuria
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