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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||December 30, 2016||N/A||Observational|
Primary Outcome 1 - Measure: Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
Primary Outcome 1 - Time Frame: 1 year
- Age 18 years or older
- Have documented or reported microscopic hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Exclusion Criteria (participants must not):
- Have history of BCa
- History of previous cancer (excluding basal and squamous cell skin cancer)
- Have a known active urinary tract infection or urinary retention
- Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0
- Have ureteral stents, nephrostomy tubes or bowel interposition
- Have recent genitourinary instrumentation (within 10 days prior to signing consent)
- Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and
upper tract imaging)
Minimum Age: 18 Years
Maximum Age: N/A
Name: Charles Rosser, MD
|University of Hawaii Cancer Center
Honolulu, Hawaii 96813
Charles Rosser, MD