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

RecruitingObservational study

Who can join

Ages 18 to 90 · All sexes

Full eligibility criteria
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)

About the study

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.

Sponsor: Cedars-Sinai Medical Center · Participants: 900 · Started: Dec 30, 2016

Contact the study team

Official record on ClinicalTrials.gov — NCT03193541

Locations in the U.S.

CaliforniaVA Long Beach Healthcare System, Long Beach
Cedars-Sinai Medical Center, Los Angeles
UCLA Medical Center, Los Angeles
Hoag Memorial Hospital Presbyterian, Newport Beach
New YorkUniversity of Rochester Medical Center, Rochester
TexasUT Southwestern Medical Center at Dallas, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.