Bladder Cancer Clinical Trial

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Efficacy and Utility of Cxbladder Tests in Hematuria Patients

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Summary

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

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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

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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.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

684

Study ID:

NCT04943380

Recruitment Status:

Active, not recruiting

Sponsor:

Pacific Edge Limited

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There are 10 Locations for this study

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Veterans Medical Research Foundation
San Diego California, 92161, United States
Bay Pines Veterans Affairs
Bay Pines Florida, 33744, United States
South Florida Veterans Affairs
Miami Florida, 33125, United States
James A Haley Veterans' Hospital
Tampa Florida, 33612, United States
Minneapolis VA Health Care System
Minneapolis Minnesota, 55417, United States
NWIHCS-Omaha VA Medical Center
Omaha Nebraska, 68105, United States
James J. Peters VAMC
New York New York, 10468, United States
Oklahoma City VA Hospital
Oklahoma City Oklahoma, 73104, United States
Medical University of South Carolina
Charleston South Carolina, 29401, United States
White River Junction VAMC
White River Junction Vermont, 05009, United States
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Study is for people with:

Bladder Cancer

Estimated Enrollment:

684

Study ID:

NCT04943380

Recruitment Status:

Active, not recruiting

Sponsor:


Pacific Edge Limited

How clear is this clinincal trial information?

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