Detecting Transitional Cell Carcinoma From Haematuria (TransTuFo)

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

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

Study Overview

• Status: Completed
• Conditions: Transitional Cell Carcinoma

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 Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom, HU16 5JQ
    • Castle Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from all patients referred to the haematuria clinic due to gross (visible) haematuria or findings on routine urinalysis suggestive of microscopic haematuria. These patients will be undergoing routine investigative cystoscopy on suspicion of urothelial cancer.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All participants; Patients with haematuria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.	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.	Outcome measure will be assessed by 6 months after trial completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.	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.	Outcome measure will be assessed by 6 months after trial completion.

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: C-Term Diagnostics Ltd; Hull York Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): May 28, 2018
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Diseases; Neoplasms, Glandular and Epithelial; Hemorrhage; Urination Disorders; Carcinoma; Carcinoma, Transitional Cell; Hematuria
• Other Study ID Numbers: R2006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No