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

Last updated: April 16, 2024
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Focal Segmental Glomerulosclerosis

Nephropathy

Treatment

N/A

Clinical Study ID

NCT03193528
Rosser-2015-7
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 gross hematuria.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Have documented or reported gross hematuria within 3 month of study enrollment

  • Willing and able to give written informed consent

Exclusion Criteria (patients must not):

  • Have history of BCa

  • History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years

  • 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) Serum creatinine value can be up to 60 days before consent, otherwise repeat

  • 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: 450
Study Start date:
December 30, 2016
Estimated Completion Date:
December 30, 2025

Study Description

Hematuria is the most common presentation of BCa with 22% of patients with gross 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 (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose 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 gross hematuria.

Connect with a study center

  • Department of Urology, Nara Medical University

    Nara,
    Japan

    Active - Recruiting

  • Nara Precfecture Seiwa Medical Center

    Nara,
    Japan

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of California Los Angeles

    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 14627
    United States

    Active - Recruiting

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas 75390
    United States

    Active - Recruiting

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