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Completed

NCT Number: NCT03256877

Detecting Transitional Cell Carcinoma From Haematuria

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.

    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.

Secondary outcomes

  1. Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.

    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.

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • C-Term Diagnostics Ltd
  • Hull York Medical School

Registry information

Official study title

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

Acronym: TransTuFo

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 22, 2017
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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