Spots Global Cancer Trial Database for Efficacy and Utility of Cxbladder Tests in Hematuria Patients
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Trial Identification
Brief Title: 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 ID: NCT04943380
Interventions
Study Description
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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Medical Research Foundation, San Diego, California, United States
Bay Pines Veterans Affairs, Bay Pines, Florida, United States
South Florida Veterans Affairs, Miami, Florida, United States
James A Haley Veterans' Hospital, Tampa, Florida, United States
Minneapolis VA Health Care System, Minneapolis, Minnesota, United States
NWIHCS-Omaha VA Medical Center, Omaha, Nebraska, United States
James J. Peters VAMC, New York, New York, United States
Oklahoma City VA Hospital, Oklahoma City, Oklahoma, United States
Medical University of South Carolina, Charleston, South Carolina, United States
White River Junction VAMC, White River Junction, Vermont, United States
Contact Details
Name: Tony Lough, PhD
Affiliation: Pacific Edge Pty Ltd
Role: STUDY_CHAIR
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