A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
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.
Inclusion Criteria:

 -  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
 mg/dL)

 -  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)