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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03193528
• Other study ID #: Rosser-2015-7
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Hematuria
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Japan	Department of Urology, Nara Medical University	Nara
Japan	Nara Precfecture Seiwa Medical Center	Nara
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (9)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Fred Hutchinson Cancer 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

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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