TransTuFo: Detecting Transitional Cell Carcinoma From Haematuria
Study Details
Study Description
Brief Summary
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All participants Patients with haematuria. |
Outcome Measures
Primary Outcome Measures
- Specificity and sensitivity of the ELISAs when compared to standard cystoscopy. [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.
Secondary Outcome Measures
- Positive and negative predictive values of the ELISAs when compared to standard cystoscopy. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Capable of giving written informed consent
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Age ≥18 years
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Referral to haematuria clinic (gross or microscopic haematuria)
Exclusion Criteria:
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Inability to provide written informed consent
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Previous radiotherapy to the bladder (e.g. prostate cancer)
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Active urinary tract infection (Patients may be re-approached at later opportunity when urinary infection is cleared and haematuria persists)
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Current or planned treatment with neoadjuvant chemotherapy or radiotherapy
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Other known malignant condition, either active or in complete remission ≤5 years
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HIV, hepatitis C, or any other known communicable disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Castle Hill Hospital | Hull | United Kingdom | HU16 5JQ |
Sponsors and Collaborators
- Hull University Teaching Hospitals NHS Trust
- C-Term Diagnostics Ltd
- Hull York Medical School
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R2006