Castle Hill Hospital
Hull, HU16 5JQ, United Kingdom
NCT Number: NCT03256877
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.
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Notify Me18 year and older
All sexes
Observational
Hull, HU16 5JQ, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Outcome measure will be assessed by 6 months after trial completion.
To examine the specificity and sensitivity of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria. The assays will provide measurements of the TF isoform concentrations present in patient urine samples, and the information on a subsequent diagnosis (or non-diagnosis) of a urothelial cancer will be obtained through reference to medical records.
Time frame: Outcome measure will be assessed by 6 months after trial completion.
To determine the positive and negative predictive values of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria.
Hull University Teaching Hospitals NHS Trust
Other Gov
Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor
Acronym: TransTuFo
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