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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    450
  • sponsor
    Charles Rosser
Updated on 9 April 2022
cancer
bladder cancer
bladder tumor
hematuria

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.

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.

Details
Condition Bladder Cancer
Clinical Study IdentifierNCT03193528
SponsorCharles Rosser
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

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

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)
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