RecruitingNCT03193541

A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

Sponsor

Cedars-Sinai Medical Center

Enrollment

900 participants

Start Date

Dec 30, 2016

Study Type

OBSERVATIONAL

Conditions

Bladder Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

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 Criteria7

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)