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

Last updated: August 19, 2024
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Focal Segmental Glomerulosclerosis

Bladder Cancer

Treatment

N/A

Clinical Study ID

NCT03193541
Rosser-2015-8
R01CA198887
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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)

Study Design

Total Participants: 900
Study Start date:
December 30, 2016
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Nara Medical University

    Nara,
    Japan

    Active - Recruiting

  • Nara Prefecture Seiwa Medical Center

    Nara, 636-0802
    Japan

    Active - Recruiting

  • VA Long Beach Healthcare System

    Long Beach, California 90822
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14620
    United States

    Active - Recruiting

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas 75390
    United States

    Active - Recruiting

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