Efficacy and Utility of Cxbladder Tests in Hematuria Patients

Pacific Edge

Status: Active, not recruiting

Conditions: Hematuria; Urothelial Carcinoma

Treatments: Diagnostic Test: Cxbladder

Study type: Observational

Funder types: Industry

Identifiers

NCT04943380

CXB/2019/VA

Details and patient eligibility

About

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

Full 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

Enrollment: 684 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

684 participants in 1 patient group

patients with hematuria undergoing investigation for UC

Description:

Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as \> 3 red blood cells per high-powered microscopy field for a properly collected urine sample.

Treatment:

Diagnostic Test: Cxbladder