Detecting Transitional Cell Carcinoma From Haematuria

Completed

• Conditions: Transitional Cell Carcinoma

• Registration Number: NCT03256877
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief 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.

Study Timeline

• Study Start: 2016-10-18
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Primary Completion: 2018-05-28
• Study Completion: 2019-05-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Castle Hill Hospital; 🇬🇧 Hull, United Kingdom