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NCT03193541Recruiting

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

Cedars-Sinai Medical Center

Start Date

12/30/2016

Completion Date

2/1/2029

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 90 years

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)

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Conditions

Bladder Cancer

Locations

VA Long Beach Healthcare System

Long Beach, California 90822

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

UCLA Medical Center

Los Angeles, California 90095

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

University of Rochester Medical Center

Rochester, New York 14620

United States

UT Southwestern Medical Center at Dallas

Dallas, Texas 75390

United States

Nara Prefecture Seiwa Medical Center

Nara, Nara 636-0802

Japan

Nara Medical University

Nara,

Japan