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To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
VA Long Beach Healthcare System
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of Rochester Medical Center
Rochester, New York, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Nara Prefecture Seiwa Medical Center
Nara, Nara, Japan
Nara Medical University
Nara, Japan
Start Date
December 30, 2016
Primary Completion Date
February 1, 2029
Completion Date
February 1, 2029
Last Updated
February 4, 2026
900
ESTIMATED participants
Lead Sponsor
Cedars-Sinai Medical Center
Collaborators
NCT07061964
NCT00026884
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