Clinical trial NCT04943380: Efficacy and Utility of Cxbladder Tests in Hematuria Patients
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematuria
Urothelial Carcinoma
Lead sponsor: Pacific Edge Limited
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 684
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: This study will be conducted with all hematuria patients who present to an outpatient clinic to undergo clinical assessment including cystoscopy and who fulfil study requirements. Consented eligible patients will attend their scheduled clinic visit and undergo all standard tests as clinically indicated.

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: 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.
timeFrame: Time Frame: The outcome measure will be assessed by 6 months after trial completion.
Secondary outcomes:
measure: Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: To compare the theoretical clinical outcome of patients tested using Cxbladder tests
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: 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.
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
measure: Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
timeFrame: The outcome measure will be assessed by 6 months after trial completion.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
city: Bay Pines
country: United States
facility: Bay Pines Veterans Affairs
state: Florida
city: Miami
country: United States
facility: South Florida Veterans Affairs
state: Florida
city: Tampa
country: United States
facility: James A Haley Veterans' Hospital
state: Florida
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Omaha
country: United States
facility: NWIHCS-Omaha VA Medical Center
state: Nebraska
city: New York
country: United States
facility: James J. Peters VAMC
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma City VA Hospital
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
Study officials:
affiliation: Pacific Edge Pty Ltd
name: Tony Lough, PhD
role: STUDY_CHAIR
References: