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

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT03193528
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-12-30
• Study First Submitted: 2017-06-17
• Study First Submitted QC: 2017-06-17
• Study First Posted: 2017-06-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria.	1 year

Secondary Outcome Measures

Name	Time	Method
To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.	1 year
To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.	1 year

Trial Locations

Locations (6)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Department of Urology, Nara Medical University; 🇯🇵 Nara, Japan

Nara Precfecture Seiwa Medical Center; 🇯🇵 Nara, Japan