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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03193541
• Other study ID #: Rosser-2015-8
• Secondary ID: R01CA198887
• Status: Recruiting
• Start date: December 30, 2016
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Charles Rosser, MD
• Phone: 310-423-5609
• Email: charles.rosser[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Hematuria
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Japan	Nara Medical University	Nara
Japan	Nara Prefecture Seiwa Medical Center	Nara
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (9)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Nara Medical University, Nara Prefecture Seiwa Medical Center, National Cancer Institute (NCI), Nonagen Bioscience Corporation, University of California, Los Angeles, University of Rochester, University of Texas, Southwestern Medical Center at Dallas, VA Long Beach Healthcare System

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.		1 year
Secondary	Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.		1 year