Efficacy and Utility of Cxbladder Tests in Hematuria Patients

Urothelial Carcinoma Clinical Trial

Official title:

An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04943380
• Other study ID #: CXB/2019/VA
• Status: Active, not recruiting
• Start date: November 8, 2019
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Pacific Edge Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

Description:

Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.

The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 684
• Est. completion date: December 2025
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.

• Able to provide a voided urine sample of the required minimum volume

• Able to give written consent

• Able and willing to comply with study requirements

• Aged 18 years or older

Exclusion Criteria:

• Prior history of bladder malignancy, prostate or renal cell carcinoma

• Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection

• Previous alkylating based chemotherapy

• Known Pregnancy.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Hematuria
• Urothelial Carcinoma

Intervention

Diagnostic Test:
• Cxbladder
The Cxbladder Detect test, developed by Pacific Edge Ltd (O'Sullivan 2012; Holyoake 2008; National Health Committee 2015b) is a molecular diagnostic test, which consists of five mRNA transcripts measured in a small volume of urine.

Locations

Country	Name	City	State
United States	Bay Pines Veterans Affairs	Bay Pines	Florida
United States	Medical University of South Carolina	Charleston	South Carolina
United States	South Florida Veterans Affairs	Miami	Florida
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	James J. Peters VAMC	New York	New York
United States	Oklahoma City VA Hospital	Oklahoma City	Oklahoma
United States	NWIHCS-Omaha VA Medical Center	Omaha	Nebraska
United States	Veterans Medical Research Foundation	San Diego	California
United States	James A Haley Veterans' Hospital	Tampa	Florida
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Edge Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.	The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with hematuria	The outcome measure will be assessed by 6 months after trial completion.
Primary	Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.	The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.	Time Frame: The outcome measure will be assessed by 6 months after trial completion.
Secondary	Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	To compare the theoretical clinical outcome of patients tested using Cxbladder tests	To compare the theoretical clinical outcome of patients tested using Cxbladder tests in combination (Triage followed by Detect and / or Resolve) before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy.	To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.	The outcome measure will be assessed by 6 months after trial completion.
Secondary	Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites	To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015	The outcome measure will be assessed by 6 months after trial completion.