Detecting Transitional Cell Carcinoma From Haematuria

NCT03256877 | Completed

• 1 other identifier: R2006
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transitional Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Outcome measure will be assessed by 6 months after trial completion.

Study Arms (1)

All participants

Patients with haematuria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Capable of giving written informed consent
• Age ≥18 years
• Referral to haematuria clinic (gross or microscopic haematuria)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• C-Term Diagnostics Ltd: collaborator
• Hull York Medical School: collaborator

Study Sites (1)

Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples.

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 22, 2017
• Study Start: October 18, 2016
• Primary Completion: May 28, 2018
• Study Completion: May 16, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)