Detecting Transitional Cell Carcinoma From Haematuria

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03256877

Acronym

TransTuFo

Enrollment

750

Registered

2017-08-22

Start date

2016-10-18

Completion date

2019-05-16

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transitional Cell Carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United Kingdom

Outcome results