NCT04943380

Efficacy and Utility of Cxbladder Tests in Hematuria Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 684 (actual)
• Sponsor: Pacific Edge Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hematuria
• Urothelial Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-08
• Primary completion: 2024-01-18
• Completion: 2025-12-01
• First posted: 2021-06-29
• Last updated: 2024-02-02

Locations

10 sites across 1 country: United States