NCT03256877

Detecting Transitional Cell Carcinoma From Haematuria

Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 750 (actual)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Transitional Cell Carcinoma

Timeline

• Start date: 2016-10-18
• Primary completion: 2018-05-28
• Completion: 2019-05-16
• First posted: 2017-08-22
• Last updated: 2019-07-29

Locations

1 site across 1 country: United Kingdom