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

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 Overview

• Status: Recruiting
• Conditions: Bladder Cancer

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 Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Charles Rosser, MD; Phone Number: 310-423-5609; Email: charles.rosser@cshs.org

Study Locations

• Japan
  • Nara, Japan
    • Recruiting
    • Department of Urology, Nara Medical University
    • Contact: Takuto Shimizu, MD; Phone Number: +81-744-22-3051
  • Nara, Japan
    • Recruiting
    • Nara Precfecture Seiwa Medical Center
    • Contact: Satoshi Anai, MD
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Amy Oppenheim; Phone Number: 310-423-3713; Email: Amy.Oppenheim@cshs.org
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Contact: Arnold Chin, MD, PhD
  • New York
    • Rochester, New York, United States, 14627
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Edward Messing, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center at Dallas
      • Contact: Yair Lotan; Phone Number: 214-648-0389; Email: yair.lotan@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Cancer Institute (NCI); University of California, Los Angeles; Fred Hutchinson Cancer Center; University of Texas; University of Rochester; Nara Medical University; Nonagen Bioscience Corporation; Nara Prefecture Seiwa Medical Center
• Investigators: Study Director: Charles Rosser, MD, Nonagen Bioscience Corporation; Principal Investigator: Hideki Furuya, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2016
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 17, 2017
• First Submitted That Met QC Criteria: June 17, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Hemorrhage; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Hematuria
• Other Study ID Numbers: Rosser-2015-7; R01CA198887 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No