Clinical trial NCT03256877: Detecting Transitional Cell Carcinoma From Haematuria
Official title: Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transitional Cell Carcinoma
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: C-Term Diagnostics Ltd
name: Hull York Medical School
First posted: 2017-08-22
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.
timeFrame: Outcome measure will be assessed by 6 months after trial completion.
Secondary outcomes:
measure: Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.
timeFrame: Outcome measure will be assessed by 6 months after trial completion.
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
Study officials:
References: