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

RECRUITINGSponsored by Cedars-Sinai Medical Center
Actively Recruiting
SponsorCedars-Sinai Medical Center
Started2016-12-30
Est. completion2029-02
Eligibility
Age18 Years – 90 Years
Locations6 sites
View on ClinicalTrials.gov →

NCT03193541

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

Age: 18 Years – 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)

Conditions2

Bladder CancerCancer

Locations6 sites

VA Long Beach Healthcare System
Long Beach, California, 90822
Mina BehdadMina.Behdad@va.gov
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Amy Oppenheim310-423-3713Amy.Oppenheim@cshs.org
UCLA Medical Center
Los Angeles, California, 90095
Ankush Sachdevaasachdeva@mednet.ucla.edu
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Clemente Reyes949-791-3049clemente.reyesrodriguez@hoag.org
University of Rochester Medical Center
Rochester, New York, 14620
Natalie CarrollNatalie_Carroll@URMC.Rochester.edu

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