Brief Title
Detecting Transitional Cell Carcinoma From Haematuria
Official Title
Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor
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 Type
Observational
Primary Outcome
Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.
Secondary Outcome
Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.
Condition
Transitional Cell Carcinoma
Study Arms / Comparison Groups
All participants
Description: Patients with haematuria.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
750
Start Date
October 18, 2016
Completion Date
May 16, 2019
Primary Completion Date
May 28, 2018
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03256877
Organization ID
R2006
Responsible Party
Sponsor
Study Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
C-Term Diagnostics Ltd
Study Sponsor
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Verification Date
July 2019